The aim of this study is to evaluate the effect of sibutramine and metformin combination therapy in comparison with sibutramine or metformin monotherapy over weight, adiposity, glucose metabolism and inflammatory state in obese patients.
The treatment of obesity is strongly recommended because it exacerbates insulin resistance, hypertension, dyslipidemia and atherosclerosis, and represents a risk factor for type 2 diabetes. Although diet and exercise are valuable in this treatment, patient compliance is a major problem. Sibutramine has been shown to be a highly effective pharmacotherapy for weigh loss in obese patients, mediated by increased satiety and an enhancement of energy expenditure. Metformin is widely used for glycemia control and is associated with a small to moderate body weight loss. We are assessing the combination of sibutramine and metformin, two agents with different mechanisms of action for control of body weight and metabolic dysregulation.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Enrollment
60
sibutramine and metformin, 15 mg per day and 850 mg per day, respectively, in a single tablet, for 180 days
15 mg per day for 180 days
Metformin 850 mg per day for 180 days
Centro Universitario de Ciencias de la Salud
Guadalajara, Jalisco, Mexico
improvement of body weight, adiposity and inflammation state defined by serum adiponectin, leptin and C reactive protein
Time frame: 6 months
improvement of metabolic profile, defined by triglycerides, total cholesterol, HDL cholesterol, LDL cholesterol, insulin, and insulin sensitivity
Time frame: 6 months
adverse events
Time frame: 6 months
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