Sibutramine-metformin Combination Versus Sibutramine and Metformin Monotherapy in Obese Patients

Study Overview
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Brief Summary
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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.

Detailed Description
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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.

Official Title
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Double-blind, Randomized Clinical Trial to Evaluate Effect of Combination Therapy of Metformin and Sibutramine Versus Metformin or Sibutramine Monotherapy Over Weight, Adiposity, Glucose Metabolism and Inflammatory State in Obese Patients

Conditions
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Obesity

Intervention / Treatment
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* Drug: Sibutramine-Metformin
* Drug: Sibutramine
* Drug: Metformin


Participation Criteria
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Eligibility Criteria
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Inclusion criteria Age between 30 and 50 years Both genders BMI between 30 and 40 Stable body weigh defined by over 5 per cent variability during the previous 3 months Fasting serum glucose less than 126 mg per dl Blood pressure over 140 and 90 mmHg Women ensuring contraceptive precautions. Communication and understanding capability. Informed consent awarding. Exclusion criteria Women were excluded if they were pregnant or lactating potential while no taking adequate contraceptive precautions Any smoking during the preceding 6 months No physical activity, defined by less than 15 minutes per day of walking Excessive physical activity equivalent to running over 60 minutes per day Known hypersensitivity to sibutramine or metformin Low commitment to follow the protocol statements Any investigational medication during the preceding 6 months Any drug or substance mayor toxicity exposure during the preceding 3 months Alcohol or any drug abuse during the previous 3 months Current medication of oral corticosteroids, anticoagulants, sympathomimetics, sympatholytics, lipid lowering drugs, any medication for type 2 diabetes, and any sibutramine interaction drug Current or previous evidence of ischemic heart disease, cardiac arrhythmia, cerebrovascular disease, chronic hepatic disease, two fold persistent elevation of ALT, AST or FA Carrying a pacemaker or any permanent bioelectronic component that could interfere with bioimpedance process Renal failure defined by serum creatinine equal or ever 1.2 mg per dL Not controlled thyroid disease defined by altered serum T3, T4 and TSH during the previous 3 months Hypertension Type 2 diabetes Anti-depressants, or any psychiatric disturbance treatment

Ages Eligible for Study
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Minimum Age: 30 Years
Maximum Age: 50 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Sibutramin-Metformin<br>Sibutramine-metformin therapy in a single tablet | Drug: Sibutramine-Metformin<br>* sibutramine and metformin, 15 mg per day and 850 mg per day, respectively, in a single tablet, for 180 days<br>* Other names: combination therapy;|
| Active Comparator: Sibutramine<br>Sibutramine monotherapy | Drug: Sibutramine<br>* 15 mg per day for 180 days<br>* Other names: Sibutramine monohidrate Hydrochloride;|
| Active Comparator: Metformin<br>Metformin monotherapy | Drug: Metformin<br>* Metformin 850 mg per day for 180 days<br>* Other names: Metformin Hydrochloride;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| improvement of body weight, adiposity and inflammation state defined by serum adiponectin, leptin and C reactive protein |  | 6 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| improvement of metabolic profile, defined by triglycerides, total cholesterol, HDL cholesterol, LDL cholesterol, insulin, and insulin sensitivity |  | 6 months | 
| adverse events |  | 6 months | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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sibutramine, metformin, obesity