CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 44 enrolled
Drug / intervention
Inulin +5 moredietary
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT01841073
NCT01841073N/ACompleted

Effect of Fermentable Carbohydrate on Glucose Homeostasis and Weight Management in Subjects With Prediabetes

Imperial College London·interventional·Posted Apr 26, 2013·Updated Nov 25, 2019

In Brief

A clinical study evaluating Inulin and Cellulose for Prediabetes. Completed, enrolled 44 participants across 1 site.

Detailed Summary

The rise in the prevalence of type 2 diabetes is related to recent lifestyle changes leading to a rise in obesity. Obesity is a risk factor for Impaired Glucose Tolerance (IGT) and diabetes. A type of fibre - fermentable carbohydrate - may help prevent diabetes in individuals with IGT by reducing appetite and food intake, and improving insulin sensitivity. Although fermentable carbohydrate is not absorbed in the small intestine it is full fermented by the colonic bacteria. The fermentation of this carbohydrate produces short chain fatty acids which act on specific G protein coupled receptors (GPR41/43) in the intestine to release GLP-1 and PYY. GLP-1 and PYY are hormones which act on appetite centres in the brain to decrease appetite. GLP-1 incretin effects and possible effect of the beta cell will increase insulin sensitivity. Short chain fatty acids also suppress the release of free fatty acids from adipocytes. Lower levels of free fatty acids in insulin resistant subject's leads to improved insulin sensitivity. This body of work will examine the effect of fermentable carbohydrate on appetite, weight loss, blood glucose control which will give an indication of the possibility of fermentable carbohydrate to prevent type 2 diabetes in this at-risk group.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsPrediabetes
CountriesUnited Kingdom
Collaborators--

Timeline

N/ACompletedFinished
2011201220132014201520162017201820192020202120222023202420252026
First PostedApr 26, 2013
Enrollment StartMar 1, 2011
Primary CompletionAug 1, 2013
Study CompletionAug 1, 2014
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 13.2 years ago

Interventions

Inulindietary

Subjects will have 4 dietary counselling sessions in the first 9 weeks of the study with a goal to lose 5% of their body weight by week 9. They will be asked to maintain their weight loss until week 18.

Cellulosedietary

Subjects will have 4 dietary counselling sessions in the first 9 weeks of the study with a goal to lose 5% of their body weight by week 9. They will be asked to maintain their weight loss until week 18.

Inulindietary

Subject will take inulin for 6 weeks in total with no other change to their diet or lifestyle.

Cellulosedietary

Subject will take cellulose for 6 weeks in total with no other change to their diet or lifestyle.

Inulindietary

Subject will take inulin for 6 weeks in total with no other change to their diet or lifestyle. Subject will wear a Continuous Glucose Monitor for 4 x 5 days during the study.

Cellulosedietary

Subject will take cellulose for 6 weeks in total with no other change to their diet or lifestyle. Subject will wear a Continuous Glucose Monitor for 4 x 5 days during the study.