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NCT01386645 · ClinicalTrials.gov registry record · NA

Effect of Dietary Glycemic Index on Beta-cell Function

A NA study of PreDiabetes and Oxidative Stress, sponsored by Seattle Institute for Biomedical and Clinical Research.

Completed
Registry status
NA
Development phase
56
Enrollment target
1
Study location

NCT01386645: Completed NA study of PreDiabetes and Oxidative Stress, sponsored by Seattle Institute for Biomedical and Clinical Research.

NCT01386645 is a NA study of PreDiabetes and Oxidative Stress that has completed, run by Seattle Institute for Biomedical and Clinical Research. The registered enrollment target is 56 participants, below the 701-participant average among 149 other PreDiabetes trials with a reported enrollment target (92% lower). The trial reports 1 study location across 1 state. According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT01386645, a NA study of PreDiabetes and Oxidative Stress, has completed, sponsored by Seattle Institute for Biomedical and Clinical Research.

COMPLETED
Registry status
NA
Development phase
56 participants
Enrollment target
1
Study location

Study 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.

Primary Outcome

The disposition index generated from an intravenous glucose tolerance test (insulin sensitivity x the acute insulin response to intravenous glucose) is a measure of beta-cell function.

Interventions

  • OTHER low glycemic index (LGI) diet
  • OTHER high glycemic index (HGI) diet plus placebo (PLAC)
  • DRUG high glycemic index diet plus N-acetylcysteine

Study Locations (1)

Washington

  • VA Puget Sound Health Care System - Seattle

Trial Details

FieldValue
Enrollment Target 56 participants
Start Date 2011-07
Est. Completion 2019-08-01
Phase NA

What the finished NCT01386645 record still lists

NCT01386645 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 56 participants, a relatively small participant target, below the 701-participant average among 149 other PreDiabetes trials with a reported enrollment target (92% lower).

The record links to 4 conditions, with PreDiabetes appearing as the primary indexed condition, and to 3 interventions - of which low glycemic index (LGI) diet is the first listed.

NCT01386645 reports a single indexed study location in Washington.

Frequently Asked Questions

What is clinical trial NCT01386645 about?

NCT01386645 is a clinical study titled "Effect of Dietary Glycemic Index on Beta-cell Function". 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 c...

What is the current status of trial NCT01386645?

This trial is currently completed. It is a NA study. The enrollment target is 56 participants. The study started on 2011-07. Estimated completion is 2019-08-01.

What conditions does trial NCT01386645 study?

This clinical trial studies the following conditions: PreDiabetes, Oxidative Stress, Impaired Glucose Tolerance, Impaired Fasting Glucose.

What interventions are being tested in trial NCT01386645?

The interventions under investigation include: low glycemic index (LGI) diet (OTHER), high glycemic index (HGI) diet plus placebo (PLAC) (OTHER), high glycemic index diet plus N-acetylcysteine (DRUG).

Who is sponsoring clinical trial NCT01386645?

This trial is sponsored by Seattle Institute for Biomedical and Clinical Research, which has 43 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT01386645 being conducted?

This trial has 1 study location across Washington. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.

Similar trials for PreDiabetes

Matched on the same primary condition, ranked to surface studies in the same phase first, then by recruiting status, no relevance scoring or editorial curation.

Where NCT01386645's enrollment target sits among peer trials

56 98th of 149 higher than 52 of 149 other PreDiabetes trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other PreDiabetes trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT01386645, the US trial registry maintained by the National Library of Medicine. NCT01386645 (small enrollment · single site footprint · completed) retrieved and formatted by PlainTrial, see methodology.