CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 56 enrolled
Drug / intervention
high glycemic index diet plus N-acetylcysteine +2 moredrug
Likely dose
high glycemic index diet plus N-acetylcysteine 600 mgfrom 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/NCT01386645
NCT01386645N/ACompleted

Effect of Dietary Glycemic Index on Beta-cell Function

Seattle Institute for Biomedical and Clinical Research·interventional·Posted Jul 1, 2011·Updated Aug 12, 2020

In Brief

A clinical study evaluating low glycemic index (LGI) diet, high glycemic index (HGI) diet plus placebo (PLAC), and 1 other intervention for Impaired Glucose Tolerance and 3 related conditions. Completed, enrolled 56 participants across 1 site.

Detailed Summary

The study will determine if increasing the highs and lows of blood glucose levels (glycemic variability) impairs insulin secretion in people with impaired glucose tolerance and/or impaired fasting glucose who are at risk for developing type 2 diabetes. Furthermore, the study will determine whether changes in beta-cell function are associated with glycemic variability and whether they are mediated by oxidative stress. To decrease or increase glycemic variability the study will provide subjects with special diets containing either low or high glycemic index foods respectively for 4 weeks. To determine if oxidative stress is a mediator, subjects on the high glycemic index diet will take either placebo or the anti-oxidant N-acetylcysteine. The study will address the hypothesis that increased glycemic variability results in increased oxidative stress and thereby exacerbates beta-cell dysfunction in individuals with impaired glucose tolerance and/or impaired fasting glucose. The findings may have important implications for the development of effective strategies aimed at the prevention and treatment of type 2 diabetes. In addition, understanding the contribution of dietary glycemic index to beta-cell dysfunction in subjects with pre-diabetes may have a significant public health impact, including changes to dietary counseling and promotion of healthier eating patterns.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

N/ACompletedFinished
201220132014201520162017201820192020202120222023202420252026
First PostedJul 1, 2011
Enrollment StartJul 1, 2011
Primary CompletionAug 1, 2019
TodayJul 2, 2026
Enrollment to primary: 8.1 yearsPosted 15.0 years ago

Interventions

low glycemic index (LGI) dietother

Following a 2 week medium glycemic index control diet (glycemic index 50-55), subjects will be provided with a weight stable low glycemic index diet (glycemic index \<35) for 4 weeks with all food provided by the Human Nutrition Lab

high glycemic index (HGI) diet plus placebo (PLAC)other

Following a 2 week medium glycemic index control diet (glycemic index 50-55), subjects will be provided with a weight stable high glycemic index diet (glycemic index \>70) for 4 weeks, all food provided by the Human Nutrition Lab. They will take placebo capsules (matching for active N-acetylcysteine (NAC) in arm 3) twice daily for the 4 weeks on the high GI diet. The NAC vs. placebo arms (arms 2 and 3) will be double-blinded.

high glycemic index diet plus N-acetylcysteinedrug

Following a 2 week medium glycemic index control diet (glycemic index 50-55), subjects will be provided with a weight stable high glycemic index diet (glycemic index \>70) for 4 weeks, all food provided by the Human Nutrition Lab. They will take N-acetylcysteine (NAC) two 600 mg capsules twice daily for the 4 weeks on the high GI diet. The NAC vs. placebo arms (arms 2 and 3) will be double-blinded.