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Home > "A" Clinical Trials Conditions > Acute Glycemic Effects of a Very Low Fat Diet in Type 2 Diabetes  Acute Glycemic Effects of a Very Low Fat Diet in Type 2 Diabetes
Acute Glycemic Effects of a Very Low Fat Diet in Type 2 Diabetes
For Condition: Diabetes Mellitus, Non-Insulin-Dependent
Status: Recruiting
Sponsor(s): National Center for Research Resources (NCRR) , Duke University,Procter & Gamble Pharmaceuticals,Jenny Craig
Synopsis: 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.
Details:
Eligibility:
Study Type: Interventional, Treatment, Randomized, Single Blind
Minimum Age/Maximum Age: 45 Years/
Genders: Both
Protocol Entry 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
Total Enrollment:
Location and Contact Information:
Overall Study Official:
RichardSurwit, Principal Investigator,
Duke University Medical Center *Recruiting*
Durham, North Carolina, 27710
United States
Recruiting Cynthia McCaskill 919-684-3019
Additional Information:
Study ID Numbers: NCRR-M01RR00030-0152; M01RR00030
Study Start Date: January 2000
Record last reviewed: November 2001
Additional information available at: clinicaltrials.gov
Clinicaltrials.gov Reference link: NCT00006432
Other Diabetes Mellitus, Non-Insulin-Dependent Studies:
1. Evaluation of the Effect on Glucose Control and Safety of AC2993 in Patients With Type 2 Diabetes Treated With Metformin, Sulfonylurea, or Metformin and Sulfonylurea Combination
2. An evaluation of an oral antidiabetic agent for the treatment of type 2 diabetes
3. Disease Management and Educational Intervention Outcomes in High-Risk Diabetics
4. Evaluation of an Orally Administered Medication When Taken in Conjunction with Pramlintide
5. Education and Group Support for Diabetic Hispanics
Related Studies:
Other Diabetes Mellitus, Non-Insulin-Dependent Clinical Trials
Other North Carolina Clinical Trials
Other Durham Clinical Trials
Acute Glycemic Effects of a Very Low Fat Diet in Type 2 Diabetes
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