Expired Study
This study is not currently recruiting Study Participants on ClinicalConnection.com. If you would like to find active studies please search for clinical trials.

Durham, North Carolina 27705


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).


Study summary:

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.


Criteria:

Inclusion Criteria: - 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 Criteria: - 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


NCT ID:

NCT00108524


Primary Contact:

Principal Investigator
William S. Yancy, MD MHS
Durham VA Medical Center HSR&D COE


Backup Contact:

N/A


Location Contact:

Durham, North Carolina 27705
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: June 25, 2018

Modifications to this listing: Only selected fields are shown, please use the link below to view all information about this clinical trial.


Click to view Full Listing

This study is not currently recruiting Study Participants on ClinicalConnection.com. The form below is not enabled.