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NCT00006432 · ClinicalTrials.gov registry record · NA

Acute Glycemic Effects of a Very Low Fat Diet in Type 2 Diabetes

A NA study of Diabetes Mellitus, Non-Insulin-Dependent, sponsored by National Center for Research Resources (NCRR).

Completed
Registry status
NA
Development phase
1
Study location

NCT00006432 is a NA study of Diabetes Mellitus, Non-Insulin-Dependent that has completed, run by National Center for Research Resources (NCRR). The trial reports 1 study location across 1 state.

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The verdict

NCT00006432, a NA study of Diabetes Mellitus, Non-Insulin-Dependent, has completed, sponsored by National Center for Research Resources (NCRR).

COMPLETED
Registry status
NA
Development phase
1
Study location

Study Summary

There is some consensus that high fat diets can contribute to the development of obesity and type 2 diabetes in humans and animals. An increase in dietary fat has been shown to produce obesity and diabetes in mice; such diet-induced diabetes can be reversed by reducing the fat in the diet. In humans, there is some evidence that low-fat diets can produce acute improvements in blood sugar control in type 2 diabetes-even in the absence of weight loss. In most human studies, however, dietary fat reduction has been accompanied by a reduction in total calorie intake. It is thus not possible to separate the effects of these 2 metabolic changes. The purpose of this study is to gather preliminary information on the effect of a very-low-fat diet on blood metabolism in persons with type 2 diabetes. The design incorporates controlled feeding procedures, and 30 men and women with type 2 diabetes will be given all foods for 4 weeks--a 2-week diet standardization period (diet composition: 35% fat, 15% protein, 50% carbohydrate), followed by a 2-week experimental diet period. The experimental diet conditions are A) continuation of the moderately-high-fat standardization diet, or B) a very-low-fat diet composed of 10% fat, 15% protein, 75% carbohydrate. Outcomes will be measured after the standardization and the experimental periods. The primary outcome variable is fasting plasma glucose; secondary outcomes are fasting insulin, carbohydrate (meal) tolerance, insulin secretion and blood lipids. In addition, we will gather descriptive data on the potential acceptability and utility of a very-low-fat diet constructed using the fat substitute, olestra (sucrose polyester). There are no results yet.

Interventions

  • PROCEDURE very low fat diet

Study Locations (1)

North Carolina

  • Duke University Medical Center - Durham

Trial Details

FieldValue
Start Date 2000-01
Phase NA

What the Registry Record Tells You About NCT00006432

The ClinicalTrials.gov registry entry for NCT00006432 describes a study currently listed as completed, categorized as NA. An enrollment target was not published in the registry record, which is common for early-stage or observational entries. The listed sponsor is National Center for Research Resources (NCRR), which has 94 total studies on file at ClinicalTrials.gov.

The record links to 1 condition, with Diabetes Mellitus, Non-Insulin-Dependent appearing as the primary indexed condition, and to 1 intervention - of which very low fat diet is the first listed.

NCT00006432 reports 1 study location spanning 1 distinct geographic area - top geographies include North Carolina.

Frequently Asked Questions

What is clinical trial NCT00006432 about?

NCT00006432 is a clinical study titled "Acute Glycemic Effects of a Very Low Fat Diet in Type 2 Diabetes". There is some consensus that high fat diets can contribute to the development of obesity and type 2 diabetes in humans and animals. An increase in dietary fat has been shown to produce obesity and diabetes in mice; such diet-induced diabetes can be reversed by reducing the fat in the diet. In humans...

What is the current status of trial NCT00006432?

This trial is currently completed. It is a NA study. The study started on 2000-01.

What conditions does trial NCT00006432 study?

This clinical trial studies the following conditions: Diabetes Mellitus, Non-Insulin-Dependent.

What interventions are being tested in trial NCT00006432?

The interventions under investigation include: very low fat diet (PROCEDURE).

Who is sponsoring clinical trial NCT00006432?

This trial is sponsored by National Center for Research Resources (NCRR), which has 94 total clinical trials registered on ClinicalTrials.gov.

Where is trial NCT00006432 being conducted?

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

Data sourced from official public datasets. See our methodology for details. Retrieved and formatted by PlainTrial Editorial

Every figure on PlainTrial is rendered directly from the ClinicalTrials.gov registry, no number is typed in by an editor. This page mirrors this trial's own ClinicalTrials.gov registry record, live from the dataset. See our editorial standards & corrections policy, the methodology behind these numbers, or report a data error.