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

This study has been completed.
Sponsor:
Collaborators:
Duke University
Procter and Gamble
Jenny Craig, Inc.
Information provided by:
National Center for Research Resources (NCRR)
ClinicalTrials.gov Identifier:
NCT00006432
First received: November 3, 2000
Last updated: June 22, 2007
Last verified: June 2007
  Purpose

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.


Condition Intervention
Diabetes Mellitus, Non-Insulin-Dependent
Procedure: very low fat diet

Study Type: Interventional
Study Design: Allocation: Randomized
Masking: Single Blind
Primary Purpose: Treatment

Resource links provided by NLM:


Further study details as provided by National Center for Research Resources (NCRR):

Study Start Date: January 2000
  Eligibility

Ages Eligible for Study:   45 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Type 2 diabetes, not tightly controlled at present
  • Not using medication (insulin or oral) to control blood sugar
  • Overweight, but generally healthy
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00006432

Locations
United States, North Carolina
Duke University Medical Center
Durham, North Carolina, United States, 27710
Sponsors and Collaborators
Duke University
Procter and Gamble
Jenny Craig, Inc.
Investigators
Principal Investigator: Richard S. Surwit, Ph.D.
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00006432     History of Changes
Other Study ID Numbers: NCRR-M01RR00030-0152, M01RR00030
Study First Received: November 3, 2000
Last Updated: June 22, 2007
Health Authority: United States: Federal Government

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases

ClinicalTrials.gov processed this record on April 23, 2014