Running head: INTEGRATED REVIEW 1

Integrative Review

Jamiris Merritt

Karen Mellott, PhD, MSN, RN

NUR 4122 Nursing Research

Bon Secours Memorial College of Nursing

April 2, 2019

“I pledge...”
INTEGRATED REVIEW 2

Abstract

Purpose: The purpose of this integrated review is to identify the relationship of intermittent

fasting on the effects of hemoglobin A1c in type 2 diabetic patients.

Background: Type 2 diabetes mellitus is a growing worldwide epidemic and correlates with the

rising obesity rates, sedentary lifestyle, and taxing on medical resources. Patients with type 2

diabetes mellitus are more likely to use medical resources three to four times in comparison to

those without diabetes.

Method: This is an integrative review in which research was collected from online databases.

The articles discussed are quantitative studies that were selected based on specific criteria. This

information was then used to determine the effects of intermittent fasting on hemoglobin A1c

levels.

Results and Findings: The evidences complied for this integrative review supports that

intermittent fasting is a safe and beneficial practice to manage glycemic control. A secondary

outcome was identified with associated benefits of weight loss and new lifestyle modifications.

Limitations: The most significant limitation is the author’s inexperience in conducting an

integrative review. Additional limitations identified included small sample size and lack of

generalizability which may decrease the strength and confidence of the studies.

Implications and Recommendations: Implications indicate that intermittent fasting is an easy

teachable alternative diet management for type 2 diabetics. Recommendations include increase

sample size, duration of study, and longevity of beneficial effects of long term intermittent

fasting therapy.
INTEGRATED REVIEW 3

Integrative Review

The purpose of this integrated review is to identify the relationship of intermittent fasting

on the effects of hemoglobin A1c in type 2 diabetic patients. There is a worldwide epidemic of

the increasing incidence of type 2 diabetes that correlates with the rising obesity rates and

sedentary lifestyles (Arnason et al., 2017). Unfortunately, the prevalence of type 2 diabetes does

not exhibit any signs of slowing down and is often closely associated with other comorbidities

such as cardiovascular disease and metabolic syndrome. It is important to recognize the

increasing prevalence of type 2 diabetes within the healthcare system and the lasting effects. The

healthcare system has experienced an increased stress level and patients utilize medical resources

three to four times the amount of individuals without diabetes (Arnason et al., 2017). A

knowledge gap was identified in respect of using intermittent fasting to fill the gap between

costly medication regimens, invasive medical procedures or unsuccessful dietary management.

It is important to begin looking at alternative complementary therapies to treatment the

growing epidemic. Lifestyle modifications and different forms of energy restriction have proven

effective, especially in the case of prevention and treatment of diabetes (Stange et al., 2013).

Intermittent energy restriction has been introduced as a complementary therapy for well managed

type 2 diabetic patients which offers a reduced burden of dietary restrictions, achievable weight

loss and effective for long term diet management. The intent of this integrative review is to

assemble appropriate literature to the researcher’s PICOT question: Does fasting influence

glucose control (HbA1c) in patients who have diabetes or prediabetes over 1 year?
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Design/Search Methods

The research design is an integrative review. The method utilized by the researchers

began with an initial search using electronic databases including PubMed and EBSCO

MEDLINE Complete. The search terms used were “fasting therapy”, “restrictive diet”, “type 2

diabetes”, “hemoglobin A1c’, ‘HbA1c’, ‘metabolic syndrome’, and ‘intermittent’. The numbers

of articles yielded by the initial search compromised of 1,516 articles from PubMed and 32

articles from EBSCO MEDLINE Complete. The articles were then fielded by year, language,

status of publication, peer review and relevance to the PICOT question. Search criteria was

further refined by limiting publishing dates to 2013- 2019, clinical trial, and peer reviewed. This

criteria narrowed the articles inclusion down to 651 articles for review. All articles obtained for

review were selected from PubMed due to the robust selection of studies. Articles were then

selected based on relevance to the PICOT question, “Does fasting influence glucose control

(HA1c) in patients who have diabetes or prediabetes over 1 year?”. The articles were then

selected based on the following inclusion criteria: type 2 diabetes, fasting intervention, and

effects on metabolic syndromes. Articles were excluded based on irrelevant titles, full test

availability, publishing language, and animal population testing. The researcher selected a

variety of quantitative articles to analyze findings. A final review of five quantitative articles

were chosen to be reviewed.

Findings and Results

The findings and results of the five reviewed studies indicate complementary alternative

therapies such as intermittent fasting/restrictive energy intake show a positive correlation in the

reduction of hemoglobin A1c levels, weight loss, and improved metabolic syndrome (Arnason et

al., 2017; Carter et al. 2018; Carter et al. 2016 & Li et al. 2017). A complete synopsis of the
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research is detailed in Tables 1 through 5. The researcher framed the review according to the

following themes: glycemic control and weight loss. The results of the literature review are

presented below.

Glycemic Control

A majority of the studies concluded four out of the five articles demonstrated a reduction

in the hemoglobin A1c levels (Arnason et al., 2017; Carter et al. 2018; Carter et al. 2016 &

Stange et al., 2013). One study observed a partial rebound effect however levels were still

significantly lower than baseline (Stange et al., 2013).

The qualitative observational study by Arnason et al. (2017) studied the short-term

biochemical effects and clinical tolerability of intermittent fasting in adults with type 2 diabetes

mellitus. Participants were recruited within the Saskatoon Health Region, general practitioner’s

offices, three additional hospitals within the area, and advertisements to the general public. The

study followed 10 adult participants with type 2 diabetes. Data was collected in three phases:

baseline, intervention, and follow up at one clinical site. Participants self-reported number of

fasting hours, blood glucose readings, physical activity, and caloric intake. Data analysis was

performed using an Ordinal Logistic Regression (ORL) and ANOVA for statistical analysis.

These tests were proven appropriate for the design of the study. Findings concluded that

intermittent fasting is a safe dietary intervention and boast improvements in body weight, fasting

glucose, and postprandial variability. Statistical findings were not significant based on the

sample size and further duration of study would present significant findings for HbA1c

measures.
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A quantitative study, open-label observational design conducted by Stange et al. (2013)

investigated the short to midterm fasting therapy to improve insulin resistance in patients with

metabolic syndrome. The study was comprised of 25 patients including 16 patients with type 2

diabetes and nine non-diabetic patients. Participants were selected from an inpatient clinic at the

Immanuel hospital. Data was collected before fasting, after fasting, and 80 days after fasting. The

following metabolic data was collected body mass index (BMI), hemoglobin A1c, glucose

control, and insulin sensitivity measures. A two-sided Mann-Whitney test, univariate analysis of

variance, and two-sided Wilcoxon signed rank test were used for statistical analysis. These tests

were appropriate for the design of the study. Based on the group comparison, findings indicated

a marked improvement in glycemic management in type 2 diabetic patients.

A quantitative parallel randomized non-inferiority clinical trial was conducted by Carter

et al. (2018) to compare the effects of intermittent energy restriction (fasting) with those of

continuous energy restriction on glycemic control in patients with type 2 diabetes mellitus. The

study was encompassed 137 adults with type 2 diabetes mellitus. Participants were recruited via

public flyers and advertisements in print and broadcast media. Participants were randomized into

allotted groups. Data was obtained at baseline, three months, and twelve months. The following

metabolic measurements were monitored hemoglobin A1c, BMI, daily steps, and fasting

glucose. Independent sample t-tests and Pearson x2 tests were used to analysis difference

between groups at baseline. The statistical tests performed were appropriate for this study.

Statistical findings demonstrated a significant drop in hemoglobin A1c levels greater than 8%

including weight loss reported.

A quantitative parallel randomized clinical trial was conducted by Carter et al. (2016)

aimed at investigating the effects of intermittent energy restriction (IER) compared to continuous
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energy restriction (CER) on hemoglobin A1c. The study was composed of 63 adults with type 2

diabetes however sustained a 19% attrition rate resulting in a completion of 51 participants.

Participants were recruited using flyers posted in public places and by advertisements in the

media. Data was collected at baseline and followed up at the end of 12 weeks and designed to

monitor hemoglobin A1c levels and weight loss. Shapiro-Wilk values, Q-Q plots, independent

samples t-tests, and Pearson chi-squared, and ANOVA were used for data analysis. The

statistical tests performed were appropriate for this study. Statistical findings demonstrated a

decrease in both hemoglobin A1c and weight loss over time but not by treatment method.

Weight loss

There was a consensus among all five studies indicating a marked improvement on

weight loss including reduction in waist circumference and lower body mass index (BMI). Body

weight measures utilized the body mass index (BMI), were discussed as an inclusion criterion in

all five studies. BMI measures varied across each study conducted. Body mass index was a key

characteristic in identifying individuals at risk for developing diabetes. Weight loss can be an

important factor to prevent diabetes and translate to fewer comorbidities and healthcare costs

(Arnason et al., 2017; Carter et al. 2018; Carter et al. 2016; Li et al. 2017 & Stange et al., 2013).

The randomized controlled explorative quantitative study by Li et al. (2017) aimed to

investigate the effects of a one-week fasting period compared to usual care of type 2 diabetes

mellitus. The initial study followed 46 adults with type 2 diabetes mellitus however only 32

participants completed the clinical study. Participants were referred by general internists and

specialist or recruited by press releases. Based on eligibility participants were randomly assigned

to a fasting program or Mediterranean diet. Data was collected at baseline assessment and a

follow up assessment after sixteen weeks. Data collection components collected monitored body
INTEGRATED REVIEW 8

mass index, blood pressure, heart rate, and hemoglobin A1c. A non-parametric analysis,

Wilcoxon rank sum test, Wilcoxon signs rank test, Shapiro-Wilk test and ANCOVA test were

used for data analysis. The statistical test performed was appropriate for this design due to the

small sample size. Findings determined that fasting helps participants lose weight, reduce

abdominal circumference, blood pressure; however, this study did not show a significant

reduction in hemoglobin A1c measures. The statistical findings do not support the author’s

hypothesis of beneficial effects on fasting on hemoglobin A1c.

Discussion and Implications for Practice

The articles for review show a positive correlation between diet management and

reduction of hemoglobin A1c and other associated metabolic syndromes. Intermittent energy

restriction proved to be superior compared to continuous energy restriction in weight reduction

and glycemic control (Carter et al., 2018). It’s important to meet the health goals of patients with

type 2 diabetes to help reduce their symptoms, improve quality of life, and prevent the

development of complications. Conventional practices to manage type 2 diabetes mellitus focus

on lifestyle changes and pharmacological methods. In three studies, Li et al., 2017; Stange et al.

2013; & Arnason et al., 2017, observed marked improvement in hemoglobin A1c, fasting

glucose, and insulin sensitivity. The noted improvements are related directly to the PICO

question: Does fasting influence glucose control (HbA1c) in patients who have diabetes or

prediabetes and aim to offer additional lifestyle modifications. However, one study highlights

medication dosage decreased over time although complete discontinuation of medication was not

met (Carter et al., 2016). Implications for practice include educating patients on the benefits of

fasting in the management of type 2 diabetes and decrease hospitalization occurrences related to

disease complication (e.g. hypoglycemia). Recommendations for future research include

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exploration in a larger randomized cohort, longer observational periods, and determine the value

of long-term benefits (Li et al., 2017 & Stange et al. 2013).

Limitations

In conducting this integrative review, the researcher encountered several limitations. An

important factor in the development of the research includes the limited experience and depth of

knowledge of the researcher. Lack of knowledge in conducting the integrative review limits the

accuracy of the information. The review conducted comprises only five articles that contain

recent research limited to the publication timeframe from 2013 to 2019. This limited the amount

of information available to the researcher. This is not an exhaustive review of the field of study

and limited to the structure of a class assignment.

Additional limitations identified in the articles chosen include small sample size, lack of

generalizability, and variable measurement tools including validity and reliability of instruments

used. A power analysis was not conducted in any of the five articles reviewed. Bias could have

been introduced based on the sampling strategies, selection criteria, and high attrition rates. High

attrition rates were observed in studies conducted by Carter et al. (2016) resulting in a loss of

29% and Carter et al. (2018) observed a loss of 19%. These limitations deteriorate the

generalizability and statistical power of the study. The remaining three studies did not experience

any participant losses. There were several design studies utilized including a parallel randomized

non-inferiority, parallel randomized control, observational, and an explorative randomized

controlled trial. The randomized controlled trials are the strongest design and provide high

quality of evidence. These studies offer a balance between major variables and help control bias

from being under or over represented. Observational studies provide the lowest quality of
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evidence. Major variables were clearly operationalized and well-defined. However, validity and

reliability of measurement tools was limited in several studies.

Conclusions
The evidence concluded for the integrative review supports the conception of

implementing an alternative diet management, intermittent fasting, for type 2 diabetes mellitus

patients (Arnason et al., 2017; Carter et al. 2018; Carter et al. 2016 & Stange et al., 2013). This is

directly associated with the themes of glycemic control and weight loss outcomes. Many

individuals with type 2 diabetes mellitus would benefit from a simple and accessible nutrition

intervention that is simple to implement and teach and improves their glycemic control (Arnason

et al., 2017). A new safe, low cost, and easily approachable alternative treatment aims to reduce

the growing type 2 diabetes mellitus epidemic and may boast secondary results of lower

comorbidity complications. In future development of new practice implementation, a larger

patient population should be designed in order maintain precision, high level of confidence, and

increase detection of differences among variables. In relation to the PICOT question being

addressed, “Does fasting influence glucose control (HbA1c) in patients who have diabetes or

prediabetes over 1 year?”, the literature review suggests a positive association with reduced

hemoglobin A1c levels with secondary gains of weight loss.

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Reference

Arnason, T.G., Bowen, M.W., & Mansell, K.D. (2017). Effects of intermittent fasting on health

markers in those with type 2 diabetes: A pilot study. World Journal of Diabetes, 8(4),

154-164. doi: 10.4239/wjd.v8.i4.154.

Carter, S., Clifton, P.M., & Keogh, J.B. (2018). Effect of intermittent compared with continuous

energy diet on glycemic control in patients with type 2 diabetes. JAMA Network

Open,1(3), Retrieved from https://www.ncbi.nlm.nih.gov/pmc/articles/PMC6324303/.

Carter, S., Clifton, P.M., & Keogh, J.B. (2016). The effects of intermittent compared to

continuous energy restriction on glycemic control in type 2 diabetes; a pragmatic pilot

trial. Diabetes Research and Clinical Practice, 122, 106-112.

doi: 10.1016/j.diabres.2016.10.010.

Li, C., Sadraie, B., Steckhan, N., Kessler, C., Stange, R., Jeitler, M., & Michalsen, A. (2017).

Effects of a one-week fasting therapy in patient with type-2 diabetes mellitus and

metabolic syndrome- A randomized controlled explorative study. Experimental and

Clinical Endocrinology & Diabetes, 125, 618-624. doi: 10.1055/s-0043-101700.

Stange, R., Pflugbeil, C., Michalsen, A., & Uehleke, B. (2013). Therapeutic fasting in patients

with metabolic syndrome and impaired insulin resistance. Forschende

Komplementärmedizin, 20, 421-426. doi: 10.1159/000357875.

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Appendix

Table 1 Li, C., Sadraie, B., Steckhan, N., Kessler, C., Stange, R., Jeitler, M., & Michalsen, A.
(2017). Effects of a one-week fasting therapy in patient with type-2 diabetes mellitus
and metabolic syndrome- A randomized controlled explorative study. Experimental and
Clinical Endocrinology & Diabetes, 125, 618-624. doi: 10.1055/s-0043-101700.
Problem 1. Authors identified the growing prevalence of excessive caloric intake associated with
Statement / an increased incidence of chronic diseases including type 2 diabetes mellitus and
metabolic syndrome.
2. The background acknowledged a deficiency in knowledge within this research topic
Background / related to the unknown effects of prolonged fasting greater than five days in patients
with type 2 diabetes mellitus.

Research Question- 3. The specific aim of the study was designed to investigating the effects of a one-week
Specific Aim or fasting period compared to usual care of type 2 diabetes mellitus.
Purpose / 4. The importance of this study was to demonstrate intermittent fasting can help prolong
Significance individual's lifespan and reduces incidence of age-associated chronic disease including
statement diabetes mellitus.

Conceptual or 1. There was no conceptual or theoretical framework identified within the study.
Theoretical
Framework
Method Design / 1. The researchers utilized a quantitative study. The design type conducted for the study
was an explorative randomized controlled clinical trial.
Philosophical
2. No philosophical underpinnings were identified.
Underpinnings
Sample / 1. The sample size was composed of 46 participates. Only 32 participates completed the
clinical study resulting in a decrease of 14 participates (about 4% attrition rate). The
attrition rate is low and has minimal significance. The sampling strategy was well
defined and systematic. Bias can be introduced due to transfer or loss of participates.
2. The clinical trial was carried out at an outpatient facility at the Immanuel Hospital
Berlin in the department of Internal and Complementary Medicine. The outpatient clinic
Setting / specialized in diabetic clients.
3. Internal review board approval was granted by the Ethics Committee of the Chartié-
Ethical University Medical Centre located in Berlin, Germany. Written consent was obtained
Considerations for all participates; confidentiality was not guaranteed by authors.

Major Variables 1. The dependent variable measured within the clinical trial was a Mediterranean diet,
Studied (and their BMI, and blood pressure. The independent variable measured the effects of intermittent
definition) fasting program followed by a Mediterranean diet on HbA1c. The fasting program
would be initiated with two pre-fasting days with moderate caloric intake followed by
seven modified fasting days for the duration of four months.
2. The independent variable was loosely defined and did not describe any guidelines or
restrictions of the diet. The dependent variable was clearly operationalized and well
 INTEGRATED REVIEW 13

defined within the article. Specific caloric intakes, dietary restrictions, duration of
fasting periods, fluid monitoring, and follow up guidelines were provided to fasting
participates.
Measurement Tool 1. The following measures were performed at baseline and at follow up appointment
after sixteen weeks: body mass index (BMI) was calculated as weight (kg)/height (m2),
blood pressure and heart rate using an automatic sphygmomanometer (Dynamap,
Criticon). Blood sample collection was obtained to measure insulin sensitivity with the
homeostasis model assessment (HOMA) and fasting plasma glucose (mmol/L) x serum
insulin (µU/mL)/25. In addition, a blood count and assays for blood lipids, hemoglobin
A1c (HbA1c) and C-peptide were performed. No instruments were identified for this
analysis. Serum concentrations of insulin were measured by immunonephelometric
methods. Standardized questionnaires, diary and interviews were utilized to document
adverse events by participates.
2. The authors did not provide validation or reliability analysis for the tools utilized in
the clinical trial.
Data Collection
3. The study was conducted from January 2013 through July 2015. All follow ups were
Method
completed by July 2015. All participates performed a baseline assessment and a follow
up assessment after sixteen +/- 2 weeks.
Data Analysis 1. A non-parametric analysis was used for the final results. The authors supported their
statistical analysis using Wilcoxon rank sum test, Wilcoxon signs rank test, performed
an ANCOVA test, and Shapiro-Wilk test for distribution.
2. This statistical test performed were appropriate for this design due to the small
sample size.
Findings / 1. The researchers discovered that fasting helped participates lose weight, reduce
Discussion abdominal circumference, blood pressure reduction and showed improvement in
glucoregulation. However, fasting did not produce evidence of significant decrease in
HbA1c levels.
2. The findings are statistically significant in the aspect of not supporting the author’s
hypothesis of beneficial effects of fasting verse diet on HbA1c levels.
3. Similar findings were supported from literature views results showing improvement
in blood pressure measurements and insulin sensitivity. However, all studies did not
find a correlation between fasting and improved HbA1c levels. The literature review
supported evidence of cardiovascular improvement as well. The length of fasting
therapy and lasting effects are still unknown.
Appraisal/Worth 1. Based on the findings, additional research is needed to observe the effectiveness of
to practice fasting programs in diabetics and to understand the effects of insulin sensitivity and
decrease in HbA1c levels.
2. Limitations within the study include small sample size, no assessment follow-up after
fasting intervention, lack of dietary adherence, and no confirmatory design.
 INTEGRATED REVIEW 14

3. Lack of significant important in HbA1c should be further investigated. This study

Table 2 does not support
Arnason, a change
T.G., Bowen, in nursing
M.W., practice.
& Mansell, K.D. (2017). Effects of intermittent fasting
 INTEGRATED REVIEW 15

on health markers in those with type 2 diabetes: A pilot study. World Journal of
Diabetes, 8(4), 154-164. doi: 10.4239/wjd.v8.i4.154
Problem 1. An increased incidence of type 2 diabetes mellitus worldwide correlated to the rising
Statement / obesity rates and sedentary lifestyles.

2. Background identified intermittent fast as a popular diet method related to weight

loss. However, literature review has offered conflicting results of worsening glycemic
Background / control and caloric deficit and minimal research has been conducted in human trials to
identify the effects and benefits of IF in individuals with type 2 diabetes mellitus.

3. The specific aim of the study was to determine the short-term biochemical effects and
Research Question- clinical tolerability of intermittent fasting in adults with type 2 diabetes mellitus.
Specific Aim or
Purpose / 4. The significance of this study is to decrease diabetic complications and associated
comorbidities that may further tax the health care system. IF therapy is important to help
Significance manage metabolic control.
statement
Conceptual or 1. There was no conceptual or theoretical framework identified within the study.
Theoretical
Framework
Method Design / 1. Quantitative observational study; observational study was conducted in three phases
Philosophical (baseline, intervention, and follow up)
Underpinnings 2. No philosophical underpinnings were identified.
Sample / 1. 10 participates (nine females and one male); sample size was not adequate.
Participates were recruited through local hospitals, doctor’s offices, and advertisements
to the general public. There was no attrition rate within the study due the retention of all
participates at the end of study. Bias could be introduced based on recruitment practice
of participates.

Setting / 2. Participants were recruited from Saskatoon Health Region and three additional
hospitals within the city of Saskatoon.

Ethical 3. Internal review board was approved by the University of Saskatchewan Biomedical
Considerations Research Ethics Board. All participates provided written consent prior to the start of the
study.
Major Variables 1. Dependent variable measured were HbA1c, BMI, blood pressure, waist
Studied (and their circumference, and physical activity.
definition) Independent variables measured were the effects of intermittent fasting during three
phases.
2. Major variables were clearly operationalized and well-defined. Dependent variables
could be assessed through self-reporting including photographic documentation, clinical
assessment and biochemical measurements.
Measurement Tool 1. Yale Physical Activity Survey (YPAS)- questionnaire utilized to capture physical
/ activity- offers test-retest reliability
Doubly-Labelled Water method (DLW)- measure energy intake; gold standard
Remote food photography method (RFPM)- visually capture dietary intake
 INTEGRATED REVIEW 16

C-reactive protein (CRP)- biomarker used to determine presence of inflammation

Table 3 Homeostasis
Stange, Model Assessment
R., Pflugbeil, (HOMA-IR)-measures
C., Michalsen, insulin resistance
A., & Uehleke, B. (2013). Therapeutic fasting in
Fasting insulin, fasting plasma glucose, height, weight, blood pressure, and waist
patients with metabolic syndrome and impaired insulin resistance. Forschende
circumference, and BMI20, 421-426. doi: 10.1159/000357875
Komplementärmedizin,

2. YPAS tool was noted for its offering of test-retest reliability. DLW was identified as
the gold standard however can be difficult to use for inexperienced individuals. RFPM
was well-known for its efficiency and accuracy for dietary intake and was utilized in
place of DLW. No additional validity or reliability was identified within the study.

3. Data was obtained in three phases: baseline (two weeks period), intervention (weeks
three to four), follow-up (weeks five to six). Participates self-reported fasting hours,
Data Collection blood glucose three times daily, physical activity, and caloric intake.
Method
Data Analysis 1. An Ordinal Logistic Regression (ORL) and ANOVA were utilized for statistical
analysis.

2. Both identified statistical analysis tests were appropriate for the design of the study.
Findings / 1. Researchers concluded the use of IF is a safe dietary intervention and boast
Discussion improvements in body weight, fasting glucose and postprandial variability. Comparative
measure of HbA1c would be optimal in a longer conducted study.

2. The statistical findings are not significant based on the sample size. Improvements
were observed in glucose control and weight management.

3.Findings related to external knowledge demonstrated a large knowledge gap. There

have not been many human trials for comparison. Literature review identified
conflicting results in the benefits of IF therapy.
Appraisal/Worth 1.Further research is needed to fully evaluate HbA1c levels.
to practice 2. Limitations identified in the study include a small sample population and unevenly
distribution, short duration of the study, and sustained effects of IF therapy.
3. Implementation of IF therapy can be easily taught to a wide audience and alternative
dietary intervention for management of type 2 diabetes. This study does not support a
change in nursing practice.
 INTEGRATED REVIEW 17

Problem 1. Type 2 diabetes and comorbidities have been shown to exert over-additive effects
Statement / including increased frequent reasons for hospitalization and contribute to considerable
health expenses.

2. Cardiovascular diseases are predominant causes of mortality in the Western world

Background / and an increase risk factor include metabolic syndrome, e.g., type 2 diabetes.

Research Question- 3. Investigate short to midterm fasting therapy (7-18 days) to improve insulin resistance
Specific Aim or in patients with metabolic syndrome.
Purpose /

Significance 4. The importance of this study is to observe patients with metabolic syndrome achieve
statement mid-to-long term improvement after a therapy fasting living with type 2 diabetes.

Conceptual or 1. There is no conceptual or theoretical framework identified within the study.

Theoretical
Framework

Method Design / 1. A quantitative study was conducted for this research study. An open-label
Philosophical observational design was followed using the Buchinger fasting method.
Underpinnings 2. No philosophical underpinnings were identified.
Sample / 1. Sample size was composed on 25 patients, 16 patients with diabetes and 9 patients
without. 13 males and 12 females comprised the 25 patients. Sampling strategy was well
defined with inclusion and exclusion criteria. Sample size was adequate. All participates
completed the study therefore no attrition rate was identified. Selection bias could be
introduced into the study.

Setting / 2. Inpatient clinic at the Immanuel Hospital.

Ethical 3. The study was conducted in accordance with the declaration of Helsinki. Patients
Considerations were fully informed about the purpose of the study, provided consent and were ensured
anonymity.
Major Variables 1. The independent variable was non-diabetic patients and the dependent variable was
Studied (and their patients with type 2 diabetes, BMI, and HbA1c.
definition)
2. Metabolic syndrome was described in the article however a clear definition was not
provided. Reference where to obtain definition was supported by World Health
Organization. Diabetes mellitus measurements were identified.
Measurement Tool 1. HOMA-IR (homeostasis model assessment for insulin resistance) = fasting insulin
/ (µU/ml) x fasting glucose (mmol/1)/ 22.5 (µU/ml x mmol/1)
Body Mass Index (BMI)
Data Collection 2. Authors determined reliability measurements for HOMA-IR= 2.8 (+/- 2.4) however
Method no additional validity of the tool was provided.
3. Blood samples were obtained on the first day of fasting and first day of refeeding in
the morning between 8:00 am-8:30 am during inpatient facility. Follow up appointments
were scheduled outpatient at 80 days. Authors did not provide a detailed data collection
 INTEGRATED REVIEW 18

method for post therapy.

Table 4 Carter, S., Clifton, P.M., & Keogh, J.B. (2018). Effect of intermittent compared with
continuous energy diet on glycemic control in patients with type 2 diabetes. JAMA
Network Open, 1, (3). doi:10.1001/jamanetworkopen.2018.0756
Data Analysis
Problem 1.
1. A
Thetwo-sided Mann-Whitney
health care test, univariate
costs of overweight, obesityanalysis
and typeof2 variance, andincreasing
diabetes are two-sidedand
Wilcoxon
traditional signed
weightrank
loss test were are
methods useddifficult
for statistical analysis.
to adhere in the long term.
Statement /
2.
2. These designshas
Background were appropriate
provided for the
evidence design offering
of effective weight comparison of single
loss in healthy sample
overweight and
Background / to independent populations.
obese population following an intermittent energy restriction (fasting) diet. Researchers
Findings / 1.
areThe authors
seeking identifiedthe
to evaluate type two of
effects diabetics benefit
intermittent more
very from fasting
low-calorie dietstherapy than non-
used within a
Discussion diabetic participates and a decrease in BMI had no correlation on the
continuous energy restriction diet within the type 2 diabetic population. effects of insulin
resistance. Short term fasting proved more beneficial than mid-term fasting.
3. The purpose of the study is to compare the effects of intermittent energy restriction
Research Question- 2. The statistical
(fasting) with thosefindings showed aenergy
of continuous marked improvement
restriction in glycemic
on glycemic management
control and weightin
Specific Aim or diabetic patients.
loss in patients with type 2 diabetes.
Purpose /
3. The findings have presented similar results from the literature review. A decrease in
HbA1c and weight loss have been the most significant finding. A new finding observed
partial rebound in insulin resistance.
Appraisal/Worth 1. Further research is needed to identify long term effects beyond six months as this
to practice study did not offer measurable data to compare effects.

2. Limitations to the study include the small sample size, one inpatient clinic utilized,
only two measurement tools provided with no reliability or validity offered, and weak
data collection methods.

3. Implications for practice offer an alternative diet management and glycemic control
for type 2 diabetics. Patients that cannot maintain regimented weight loss programs or
diets may find this option easier to follow. This study does support a change in nursing
practice.
 INTEGRATED REVIEW 19

4. Important of this study is to explore an alternative weight loss method in patients with
Significance type 2 diabetes.
statement
Conceptual or 1. There is no conceptual or theoretical framework identified within the study.
Theoretical
Framework
Method Design / 1. A quantitative study was conducted. The design of the study was a parallel
Philosophical randomized noninferiority trial.
Underpinnings 2. No philosophical underpinnings were identified.

Sample / 1. Sample size included 137 adult participates with type 2 diabetes. 77 women and 60
men were opted to participate in the randomized study. Participates were recruited via
public flyers and advertisements in print and broadcast media. The sample size was
divided into two even (n=67) diet groups: intermittent energy restriction or continuous
energy restriction. 46 participates completed continuous energy restriction diet and 51
completed intermittent energy restriction group. Sample size was adequate and noted a
loss of 40 participates. Attrition rate was identified. Selection bias could be introduced
into the study.

Setting / 2. The study was conducted at the Sansom Institute of Health Research, University of
South Australia.

Ethical 3. Internal review board was granted by the University of South Australia Human
Considerations Research Ethics Committee. All participates provided written informed consent.
Major Variables 1. The dependent variable was identified as intermittent energy restriction diet, BMI,
HbA1c, and physical activity. Continuous energy restriction was identified as the
Studied (and their
definition) independent variable. Intermittent energy restriction (fasting) followed a 500 to 600
kcal/day for two days of the week followed by participates usual diet for the remaining
five days. Continuous energy restriction group followed a 1,200-1,500 kcal/d.
2. Major variables are clearly operationalized, well defined, and described thoroughly as
an intervention.
Measurement Tool 1. Diabetes Care Analyzer (DCA) Vantage Analyzer (Siemens Healthcare Diagnostics)
/ utilized to measure HbA1c level, disposable lancets used to obtain blood sample, BMI,
body composition measured by dual energy x-ray absorptiometry (Lunar iDXA, Getz
Healthcare), daily step count measured using waistband pedometer (G-sensor, Pocket
pedometer, Walking with Attitude), and Konelab analysis (Konelab 20XTi, Thermo
Electron Corporation) utilized to measure fasting glucose and lipid levels.

2. Vantage analyzer was calibrated every two weeks ensuring validity and reliability.
Body weight measured on calibrated digital scales. Dual energy x-ray absorptiometry
performed by licensed radiation technician. No additional information was provided on
reliability or validity of measurement tools.

Data Collection 3. All outcome measures were taken at baseline, three months, and twelve months.
Method
 INTEGRATED REVIEW 20

Data Analysis 1. P value was used for statistical significance. Independent samples t tests and Pearson
Table 5 x2 tests S.,
Carter, were used to
Clifton, analyze
P.M., differences
& Keogh, betweenThe
J.B. (2016). groups as of
effects baseline.
intermittent compared to
2. Statistical analysis were appropriate for the design.
continuous energy restriction on glycemic control in type 2 diabetes; a pragmatic pilot
Findings / trial. Diabetes Research
1. Researchers discoveredand Clinical Practice,
a significant 122, 106-112.
drop in HbA1c baseline doi:
within 12 months with
Discussion 10.1016/j.diabres.2016.10.010
no different between treatment group (continuous energy restriction) verse intermittent
Problem 1. Overweight
energy andgroup.
restriction obesityParticipates
are major risk
withfactors
a HbA1cin the development
greater of type
than 8% saw the 2greatest
diabetes
Statement / mellitus
reductionwith approximately
opposed 90% with
to participates of thelevels
population with
less than 6%.type 2 diabetes mellitus being
overweight or obese.
Background / 2. Statistical findings demonstrated that intermittent energy restriction and continuous
2. Weight
energy loss is known
restriction to improve treatments
were comparable metabolic outcomes,
and observed witha decrease
a reduction of only 5-
in HbA1c levels
10% body weight leading to improvements in glycemic
Weight loss reduction had a larger variance between each group. control, lipid profile and blood
pressure.
3.External knowledge was limited in this area acknowledged by the authors because this
3.
wasThethespecific aimconducted
first study of the study in was to investigate
comparing the effects
intermittent energyofrestriction
intermittent energy
in comparison
Research Question- restriction (IER) compared to continuous energy restriction (CER) on hemoglobin A1c
to continuous energy restriction in type 2 diabetes. It was discovered that baseline
Specific Aim or (HbA1c).
HbA1c levels played a major factor in the intervention of glycemic control.
Purpose /
Appraisal/Worth 1. Further research is needed to observe marked improvement in type 2 diabetics and
to practice 4. The important
comparable ofto
results this
thestudy
length can
ofhelp achieve
disease and maintain weight loss and offer an
history.
Significance
2.Limitations of the study was identified as lack of generalizability, more frequent visits
to dietitian within the clinical setting, and under reporting of hypoglycemic and
hyperglycemic events. Sample profile of well controlled type 2 diabetics and lack of
prior research for comparison.

3. Fasting therapy can help improve HbA1c levels and promote weight loss. It is a safe
alternative to diet management and glycemic control for type 2 diabetes. This study
does support a change in nursing practice.
 INTEGRATED REVIEW 21

statement alternative treatment strategy for clinical practice.

Conceptual or 1. There was no conceptual or theoretical frame work identified within the study.
Theoretical
Framework
Method Design / 1. A quantitative study was conducted. A parallel randomized controlled trial was the
design type.
Philosophical
Underpinnings 2. No philosophical underpinnings were identified.
Sample / 1. Sample size=63, participants were recruited using flyers posted in public places and
by advertisements in the media. The sample size was adequate. There was a loss of 12
participants resulting in a high attrition rate (19%). Bias could be introduced based on
selection process and loss of participants.

Setting / 2. Appointments held at the University of South Australia.

Ethical 3. Ethics approval was granted from University of South Australia Human Research
Considerations Ethics Committee. Participants acknowledged informed consent and signed waivers.
Major Variables 1. The independent variable measured the effects of dietary interventions. The
Studied (and their dependent variables were HbA1c and weight loss (BMI).
definition)
2. Major variables were clearly operationalized and well defined.
Measurement Tool 1. DCA Vantage Analyzer was used to measure HbA1c. SECA electronic scale was
/ used to obtain weight, Dual X-ray Absorptiometry (DXA) was used to assess body
composition. G-sensor accelerometer pedometer waistband pedometers monitor and
record daily steps. Visual analogue scale (VAS) record appetite markers.
2. DCA Vantage Analyzer was calibrated nightly offering reliability. Weight was
measured using a calibrated electronic scale offering reliability. Dual energy x-ray
absorptiometry was performed by licensed radiation technician. Visual analogue scale
using a validated Likert scale. No additional information was provided on reliability and
validity of tools utilized.
Data Collection
Method 3. Data was gathered at baseline and at 12 weeks
Data Analysis 1. Shapiro-Wilk values, Q-Q plots, independent samples t-tests and Pearson Chi-squared
were used to analyze differences between groups at baseline. ANOVA statistical
analysis was used over the length of time and by treatment.
2. Statistical analysis was appropriate for the design.
Findings / 1. The researchers discovered a decrease in both HbA1c and weight over time but not
Discussion by treatment. An association was observed in loss of body fat and exercise which are
known to contribute to improved glycemic control.
2. Statistical findings were significant showing marked improvement in HbA1c levels
and weight loss.
3. The findings found similar outcomes to external knowledge. However, there was a
contradiction identified from the literature review related to duration of diabetes and
HbA1c improvement; which indicates beta cell function impacts on response to energy
restriction.
 INTEGRATED REVIEW 22

Appraisal/Worth 1. Further research is needed due to the limited generalizability and conducted on a
to practice larger scale to determine true effects.
2. Limitations to the study include high attrition rate, limited validity and reliability of
measurement tools, and weak data collection methods.
3. Implication for practice offers an alternative unconventional diet management and
reduction in weight loss. Additional management of medication and insulin usage could
be reviewed as secondary aim. This study does support a change in nursing practice.