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Tracking Information | |||||
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First Received Date † | November 3, 2000 | ||||
Last Updated Date | June 22, 2007 | ||||
Start Date † | January 2000 | ||||
Current Primary Outcome Measures † | |||||
Original Primary Outcome Measures † | |||||
Change History | Complete list of historical versions of study NCT00006432 on ClinicalTrials.gov Archive Site | ||||
Current Secondary Outcome Measures † | |||||
Original Secondary Outcome Measures † | |||||
Descriptive Information | |||||
Brief Title † | Acute Glycemic Effects of a Very Low Fat Diet in Type 2 Diabetes | ||||
Official Title † | |||||
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. |
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Detailed Description | |||||
Study Phase | |||||
Study Type † | Interventional | ||||
Study Design † | Treatment, Randomized, Single Blind | ||||
Condition † | Diabetes Mellitus, Non-Insulin-Dependent | ||||
Intervention † | Procedure: very low fat diet | ||||
Study Arms / Comparison Groups | |||||
Publications * | |||||
* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline. |
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Recruitment Information | |||||
Recruitment Status † | Completed | ||||
Enrollment † | |||||
Completion Date | |||||
Primary Completion Date | |||||
Eligibility Criteria † | Inclusion Criteria:
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Gender | Both | ||||
Ages | 45 Years and older | ||||
Accepts Healthy Volunteers | No | ||||
Contacts †† | |||||
Location Countries † | United States | ||||
Expanded Access Status | |||||
Administrative Information | |||||
NCT ID † | NCT00006432 | ||||
Responsible Party | |||||
Secondary IDs †† | M01RR00030 | ||||
Study Sponsor † | National Center for Research Resources (NCRR) | ||||
Collaborators †† |
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Investigators † |
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Information Provided By | National Center for Research Resources (NCRR) | ||||
Verification Date | June 2007 | ||||
† Required WHO trial registration data element. †† WHO trial registration data element that is required only if it exists. |