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

NCT00006432 | Completed

• 2 other identifiers: NCRR-M01RR00030-0152M01RR000030
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief 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

very low fat diet PROCEDURE

Eligibility Criteria

• Age: 45 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Type 2 diabetes, not tightly controlled at present
• Not using medication (insulin or oral) to control blood sugar
• Overweight, but generally healthy

Sponsors & Collaborators

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

Study Sites (1)

Duke University Medical Center

Durham, North Carolina, 27710, United States

Location

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Richard S. Surwit, Ph.D.

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Purpose: TREATMENT
• Sponsor Type: NIH

Study Record Dates

• First Submitted: November 3, 2000
• First Posted: November 6, 2000
• Study Start: January 1, 2000
• Last Updated: June 25, 2007

Record last verified: 2007-06

Locations

US (1)