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

NCT00006432 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL

Last updated 2007-06-25

No results posted yet for this 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.

Conditions

  • Diabetes Mellitus, Non-Insulin-Dependent

Interventions

PROCEDURE

very low fat diet

Sponsors & Collaborators

  • Duke University

    collaborator OTHER

  • Procter and Gamble

    collaborator INDUSTRY

  • Jenny Craig, Inc.

    collaborator INDUSTRY

  • National Center for Research Resources (NCRR)

    lead NIH

Principal Investigators

  • Richard S. Surwit, Ph.D.

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE

Eligibility

Min Age
45 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2000-01-31

Countries

  • United States

Study Locations

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Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00006432 on ClinicalTrials.gov