The effect of Topiramate on weight loss in Iranian patients with diabetes type 2
Phase 3
- Conditions
- Obesity.Obesity, unspecified
- Registration Number
- IRCT201112036027N2
- Lead Sponsor
- Tehran University of Medical sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete
- Sex
- All
- Target Recruitment
- 80
Inclusion Criteria
1- patients aged 18–75 years 2-body mass index (BMI) between 27 and 50 kg/m2 3-documented history of type 2 diabetes mellitus 4- glycosylated hemoglobin (HbA1c) less than 11% 5- blood pressure (BP) less than 160/105 mmHg 6-constant weight for at least 3 months (±3 kg). Exclusion criteria: 1-History of central nervous system (CNS) related or psychiatric disorders 2-Significant renal, hepatic or thyroid disease 3- Pregnancy 4- Sever diabetes complications
Exclusion Criteria
Not provided
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Percent change in body weight. Timepoint: End of the study. Method of measurement: Body mass index measurment.
- Secondary Outcome Measures
Name Time Method Change in systolic and Diastolic blood pressure. Timepoint: At the end of study. Method of measurement: Blood pressure measurment.;Changes in glycosylated hemoglobin (HgA1c). Timepoint: At the end of study. Method of measurement: HbA1C measurment.;Changes in lipid profile (total cholesterol, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol, triglycerides). Timepoint: At the end of study. Method of measurement: Lipid profile measurment.;Proportion of subjects who achieved 5% or 10% weight loss (5% and 10% weight responders). Timepoint: At the end of study. Method of measurement: weight measurment with standadrd method.