Status:
COMPLETED
A Low-Carbohydrate, Ketogenic Diet Versus Orlistat for Weight Loss
Lead Sponsor:
US Department of Veterans Affairs
Conditions:
Diabetes Mellitus
Obesity
Eligibility:
All Genders
18-69 years
Phase:
NA
Brief Summary
This study compares two types of diet interventions: a low carbohydrate ketogenic diet (Atkins) and a low-fat diet combined with a medication (Orlistat).
Detailed Description
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 ava...
Eligibility Criteria
Inclusion
- Participants must have a VA medical center primary care provider;
- 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.
Exclusion
- No VAMC primary care provider
- Unable to attend regular study visits
- No access to telephone
- BMI \< 27
- Contraindications to Orlistat
- Pregnancy, breast feeding or planning to become pregnant
- Unstable mental health illness
- Use of a weight loss therapy in the month prior to screening
Key Trial Info
Start Date :
July 1 2004
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 1 2007
Estimated Enrollment :
146 Patients enrolled
Trial Details
Trial ID
NCT00108524
Start Date
July 1 2004
End Date
December 1 2007
Last Update
April 17 2014
Active Locations (1)
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1
Durham VA Medical Center HSR&D COE
Durham, North Carolina, United States, 27705