Low Carbohydrate Diet |
Living Low Carb; Living Low Carb Diet; Low Carb; Low Carb Diet; Low Carbohydrate; Low Carbs |
Clinical Trial: A Low-Carbohydrate, Ketogenic Diet versus Orlistat for Weight Loss
This study is not yet open for patient recruitment.
|
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 | Treatment or Intervention |
|---|---|
| Obesity Diabetes Mellitus | Behavior: Low carbohydrate ketogenic diet Drug: Orlistat plus a low-fat diet |
MedlinePlus related topics: Diabetes; Obesity
Study Type: Interventional
Study Design: Treatment, Randomized, Open Label, Uncontrolled, Parallel Assignment, Safety/Efficacy Study
Expected Total Enrollment: 150
Study start: July 2004; Expected completion: 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 - 69 Years, Genders Eligible for Study: Both
Accepts Healthy Volunteers
Criteria
Inclusion Criteria:
- Failed first line diet and exercise recommendations;
- In stable health by screening physical and lab tests;
- Agrees to make regular visits per study protocol;
- Has access to telephone;
- Body mass index (BMI) > or = 27 with obesity-related illness OR BMI > or = 30 with no risk factors;
- No contraindications to Orlistat;
- Not pregnant or breast-feeding;
- No serious mental health illness such as dementia or schizophrenia;
- No use of a weight loss therapy in the month prior to screening.
Location and Contact Information
North Carolina
Durham VA Medical Center, Durham, North Carolina, 27705, United States
William Yancy, Jr., M.D., Principal Investigator
More Information
Record last reviewed: April 2005
Last Updated: April 15, 2005
Record first received: April 15, 2005
ClinicalTrials.gov Identifier: NCT00108524
Health Authority: United States: Federal Government
ClinicalTrials.gov processed this record on 2005-05-03
Source: ClinicalTrials.gov
Cache Date: May 4, 2005

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