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

This study has been completed.

Sponsors and Collaborators: National Center for Research Resources (NCRR)
Duke University
Procter and Gamble
Jenny Craig, Inc.
Information provided by: National Center for Research Resources (NCRR)
ClinicalTrials.gov Identifier: NCT00006432
  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

MedlinePlus related topics:   Diabetes   

U.S. FDA Resources

Study Type:   Interventional
Study Design:   Treatment, Randomized, Single Blind

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
National Center for Research Resources (NCRR)
Duke University
Procter and Gamble
Jenny Craig, Inc.

Investigators
Principal Investigator:     Richard S. Surwit, Ph.D.    
  More Information


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

Study placed in the following topic categories:
Metabolic Diseases
Diabetes Mellitus, Type 2
Diabetes Mellitus
Endocrine System Diseases
Endocrinopathy
Metabolic disorder
Glucose Metabolism Disorders

ClinicalTrials.gov processed this record on October 03, 2008




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