A Low-Carbohydrate, Ketogenic Diet Versus Orlistat for Weight Loss
Diabetes Mellitus, Obesity
About this trial
This is an interventional treatment trial for Diabetes Mellitus focused on measuring anti-obesity agents, diet therapy, diet, reducing, obesity, overweight, risk factors, weight loss
Eligibility 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
Sites / Locations
- Durham VA Medical Center HSR&D COE
Arms of the Study
Arm 1
Arm 2
Experimental
Active Comparator
Low Carbohydrate Ketogenic Diet
Low-Fat Diet plus Orlistat
Participants receive dietary counseling over 48 weeks aimed at helping them to lower starch and sugar intake.
Participants receive counseling on a low fat diet over 48 weeks aimed at reducing fat and calorie intake, and additionally receive Orlistat taken 3 times daily.