Diabetes Mellitus, Type 2 Clinical Trial
Official title:
The Effect of Viscous Fibre on Glycemic Control in Individuals With Diabetes
Purpose of Study (The Effect of Viscous Fiber on Glycemic Control (VF & GC) in Individuals
with Diabetes Mellitus.
According to the World Health Organization, about 347 million individuals are living with
diabetes. (http://www.who.int/features/factfiles/diabetes/facts/en/, accessed on Nov. 23,
2015). Over the last decades, dietary fibers, namely dietary viscous fibers, have emerged as
a nutrition component that may improve the postprandial glycemic response and hence aid in
long term diabetes management. It is believed that supplementation with viscous fibers can
control blood glucose by increasing viscosity of the gastric digesta, hence delaying gastric
emptying and retarding entry of glucose into the bloodstream to result in a diminished
postprandial rise in blood glucose. (Chutkan et al., 2012).
Currently, the evidence of the relationship between viscous fibers and diabetes is mixed. The
systematic review method depends on combining data from many small studies in order to get a
pooled estimate of the true effect. The purpose of this study is to conduct a systematic
review and meta-analysis of randomized controlled trials (RCTs) investigating the fasting
glycemic and insulinemic effect of viscous fiber supplementation. We hope the findings of
this study will play a key role in developing the nutritional guidelines for individuals with
diabetes mellitus.
Background: Diet high in total dietary fiber content has been recommended for individuals
with diabetes mellitus. However, the effect of supplementing diet with viscous fiber such as
guar gum, beta glucan, psyllium, konjac, or other viscous fibers on glycemic and insulinemic
outcomes in individuals with diabetes mellitus is still controversial.
Objective: To improve the evidence-based guidelines/ recommendations for diabetes mellitus,
we will conduct a systematic review and meta-analysis on the effect of viscous fiber
supplementation on glycemic control endpoints in individuals with diabetes mellitus.
Design: Cochrane handbook for systematic review of interventions will be used for planning
and conducting this meta-analysis. The reporting will follow the Preferred Reporting Items
for Systematic Reviews and Meta-analyses (PRISMA) guidelines.
Data sources: MEDLINE, EMBASE, the Cochrane Central Register of Controlled Trials will be
searched using appropriate pre-determined search terms.
Study selection: All the included trials must be randomized, controlled, with duration of ≥ 3
weeks investigating the effect of supplementing diet with viscous fiber on glycemic control
outcomes in individuals with diabetes mellitus. Acute studies, non-randomized, not
appropriately controlled studies will be excluded. Both isocaloric and non-isocaloric will be
included.
Data extraction: Two independent reviewers will extract information about fiber type, sample
size, subject characteristics, dose, follow-up, composition of the background diets, and
statistical analyses. Mean±SEM values will be extracted for all outcomes. Standard
computation and imputation will be used to derive all missing variance data. Risk of bias and
study quality will be assessed using the Cochrane Risk of Bias Tool and the Grading of
Recommendations Assessment, Development and Evaluation (GRADE), respectively.
Outcome: This meta-analysis will assess a set of outcomes related to glycemic control in
individuals with diabetes mellitus. These outcomes are: (1) glycated hemoglobin A1c (HbA1c),
(2) fasting glucose (FG), (3) fasting insulin (FI), (4) fructosmine, and (5) Homeostasis
model assessment of insulin resistance (HOMA-IR).
Data synthesis: Pooled analysis will be conducted using the Generic Inverse Variance method.
Rand-effects models will be used even in the absence of statistical significant between-study
heterogeneity because they yield more conservative summary effect estimates in the presence
of residual heterogeneity. Heterogeneity will be assessed using Cochran's Q test and
quantified by the I2 statistic. Sensitivity and subgroup analyses will be used to explore
sources of heterogeneity. A prioir subgroup analyses include study design, does, fiber type,
follow-up (duration), baseline values, study quality, food matrix, and composition of the
background diet. The significance of subgroup analyses will be assessed using meta-regression
analyses. Publication bias will be assessed using the inspection of funnel plots and
application of Egger's and Begg's tests.
Knowledge translation plan: Results will be shared through traditional, national, and
international scientific meetings and they will be submitted to high impact factor journals
for publication.
Significance: We hope the results of this study will play a role in improving the guidelines/
recommendations for individuals with diabetes mellitus by raising the awareness towards
viscous fiber consumption among health providers, patients, and industry. Hopefully, this
study will aid in guiding future research in the dietary fiber field.
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