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| Sponsored by: |
Department of Veterans Affairs |
| Information provided by: | Department of Veterans Affairs |
| ClinicalTrials.gov Identifier: | NCT00108524 |
Purpose
This study compares two types of diet interventions: a low carbohydrate ketogenic diet (Atkins) and a low-fat diet combined with a medication (Orlistat).
| Condition | Intervention |
|
Obesity Diabetes Mellitus |
Behavioral: Low carbohydrate ketogenic diet Drug: Orlistat plus a low-fat diet |
| MedlinePlus related topics: | Diabetes Obesity Weight Control |
| ChemIDplus related topics: | Orlistat |
| Study Type: | Interventional |
| Study Design: | Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study |
| Official Title: | A Low-Carbohydrate, Ketogenic Diet Versus Orlistat for Weight Loss |
| Estimated Enrollment: | 150 |
| Study Start Date: | July 2004 |
| Estimated Study Completion Date: | April 2008 |
Overweight and obesity are increasingly prevalent in the veteran population as well as the general public. For patients with obesity-associated illnesses, there are few effective treatment options available after failed attempts at diet and exercise, even though weight loss has been shown to alleviate these conditions. The purpose of this study is to compare the tolerability, safety, and efficacy of a low-carbohydrate ketogenic diet (Atkins) with a combination of a low-fat diet and Orlistat. The outcomes examined over a 48 week duration will include body weight, risk factors for heart disease (e.g., lipid profiles), and blood sugar. This is a randomized, parallel-intervention trial. Subjects (n=150) will be recruited from the Durham VAMC Ambulatory Care Clinics. All patients receive one of the two intensive weight loss interventions.
Eligibility
| Ages Eligible for Study: | 18 Years to 69 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | Yes |
Inclusion Criteria:
Contacts and Locations
More Information
| Study ID Numbers: | CLIN-005-03F |
| First Received: | April 15, 2005 |
| Last Updated: | July 5, 2007 |
| ClinicalTrials.gov Identifier: | NCT00108524 |
| Health Authority: | United States: Federal Government |
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