Ignite Creation Date:
2024-05-06 @ 10:26 AM
Last Modification Date:
2024-10-26 @ 12:30 PM
Study NCT ID:
NCT03259724
Status:
UNKNOWN
Last Update Posted:
2017-08-24
First Post:
2017-08-21
Brief Title:
The Effect of NVFS on GC in Individuals With DM SR MA of RCTs
Sponsor:
Unity Health Toronto
Organization:
Unity Health Toronto
Study Overview
Official Title:
The Effect of Non-Viscous Fibre Supplementation on Glycemic Control in Individuals With Diabetes Mellitus A Systematic Review Meta-analysis of RCTs
Status:
UNKNOWN
Status Verified Date:
2017-08
Last Known Status:
ACTIVE_NOT_RECRUITING
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
NVFSGC
Brief Summary:
Purpose of Study The Effect of Non-Viscous Fibre Supplementation on Glycemic Control NVFS GC in Individuals with Diabetes Mellitus
Regardless of the remarkable advancement in pharmacotherapy diabetes mellitus remains a major concern with more than 300 millions living with its complications including CVD Nutrition is a cornerstone in diabetes management and increasing total dietary fibre have been shown to decrease HbA1c fasting glucose fasting insulin fructosamine and HOMA-IR However the main underlying mechanism is still not fully understood and the specific type and proportion of fibre supplementation to be recommended for such individuals is still controversial
Currently the available findings results from small RCTs are inconsistent The systematic review method depends on combining data from many small studies in order a pooled estimate of the pooled effect The purpose of this study is to conduct a systematic review and meta-analysis of randomized controlled trials RCTs assessing the effect of non-viscous fibre supplementation on fasting glucose and insulin in individuals with diabetes mellitus We hope the findings of this study will play a role in developing the nutritional guidelines for individuals with diabetes mellitus
Regardless of the remarkable advancement in pharmacotherapy diabetes mellitus remains a major concern with more than 300 millions living with its complications including CVD Nutrition is a cornerstone in diabetes management and increasing total dietary fibre have been shown to decrease HbA1c fasting glucose fasting insulin fructosamine and HOMA-IR However the main underlying mechanism is still not fully understood and the specific type and proportion of fibre supplementation to be recommended for such individuals is still controversial
Currently the available findings results from small RCTs are inconsistent The systematic review method depends on combining data from many small studies in order a pooled estimate of the pooled effect The purpose of this study is to conduct a systematic review and meta-analysis of randomized controlled trials RCTs assessing the effect of non-viscous fibre supplementation on fasting glucose and insulin in individuals with diabetes mellitus We hope the findings of this study will play a role in developing the nutritional guidelines for individuals with diabetes mellitus
Detailed Description:
Background High fibre diets have been recommended for individuals with diabetes mellitus However the findings on the effect of non-viscous fibre supplementation such as inulin wheat bran and resistant starch on glycemic control in individuals with diabetes are inconsistent
Objective In order to improve the evidence-based guidelines for diabetes mellitus we will conduct a systematic review and meta-analysis to assess evidence from randomized controlled trials RCTs on the effect of non-viscous fibre supplementation on glycemic control in individuals with diabetes
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-analysis PRISMA guidelines
Data sources MEDLINE EMBASE the Cochrane Central Register for 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 non-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 MeanSEM 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 or 2 fructosamine 3 fasting glucose FG 4 fasting insulin FI 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 Cochrans Q test and quantified by the I2 statistic Sensitivity and subgroup analyses will be used to explore sources of heterogeneity A priori 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 Eggers and Beggs tests
Knowledge translation plan Results will be shared through traditional national and international scientific meetings and they may 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
Objective In order to improve the evidence-based guidelines for diabetes mellitus we will conduct a systematic review and meta-analysis to assess evidence from randomized controlled trials RCTs on the effect of non-viscous fibre supplementation on glycemic control in individuals with diabetes
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-analysis PRISMA guidelines
Data sources MEDLINE EMBASE the Cochrane Central Register for 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 non-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 MeanSEM 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 or 2 fructosamine 3 fasting glucose FG 4 fasting insulin FI 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 Cochrans Q test and quantified by the I2 statistic Sensitivity and subgroup analyses will be used to explore sources of heterogeneity A priori 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 Eggers and Beggs tests
Knowledge translation plan Results will be shared through traditional national and international scientific meetings and they may 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None