Obesity. Obesity, unspecified
Conditions
Interventions
Intervention 1: Intervention: The 3-week titration phase began with administration of 25mg topiramate once every morning to subjects assigned to that group. In the second week, topiramate was administ
Treatment - Drugs
Placebo
Intervention: The 3-week titration phase began with administration of 25mg topiramate once every morning to subjects assigned to that group. In the second week, topiramate was administered at 25mg twi
Control:The 3-week titration phase began with administration of 25mg placebo tablet( prduced by Arya pharmacy company) that had shape and cover similar to topiramate tablets once every morning to subj
Sponsors
Tehran University of Medical sciences
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: 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
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Percent change in body weight. Timepoint: End of the study. Method of measurement: Body mass index measurment. | — |
Secondary
| Measure | Time frame |
|---|---|
| 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. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactSedighe Moradi
Tehran University of Medical Sciences
Outcome results
None listed