Obesity is a complex disease that represents a growing epidemic worldwide. Obesity is no longer a cosmetic issue; it has been found to be associated with several co morbidities and increased mortality. In general, the use of medication promotes only a modest weight loss, in the range of 2 to 10kg. The effects are generally maximal during the first 6 months of therapy. The aim of this study was to assess the effect of Topiramate on weight reduction in a group of obese diabetic patients. In this study, 85 subjects were included. Patients were assigned in two treatment groups with Topiramate and Placebo. All subjects participated in a non-pharmacologic lifestyle intervention program. Primary efficacy end points were percent change in body weight at the end of the study. Secondary end points were change in blood pressure(BP), proportion of subjects who achieved 5% or 10% weight loss, changes in lipid profile (total cholesterol, low-density lipoprotein cholesterol, high-density lipoprotein cholesterol, triglycerides) ; and changes in glycosylated hemoglobin (HgA1c).
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201112036027N2
Registration date:2012-02-18, 1390/11/29
Registration timing:retrospective
Last update:
Update count:0
Registration date
2012-02-18, 1390/11/29
Registrant information
Name
Sedigheh Moradi
Name of organization / entity
Tehran university of Medical Sciences
Country
Iran (Islamic Republic of)
Phone
+98 21 8894 5247
Email address
s-moradi@tums.ac.ir
Recruitment status
Recruitment complete
Funding source
Tehran University of Medical Sciences
Expected recruitment start date
2008-10-01, 1387/07/10
Expected recruitment end date
2010-01-01, 1388/10/11
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of Topiramate on weight loss in Iranian patients with diabetes type 2
Public title
The effect of Topiramate on weight loss in Iranian patients with diabetes type 2
Purpose
Treatment
Inclusion/Exclusion 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
Age
From 18 years old to 75 years old
Gender
Both
Phase
3
Groups that have been masked
No information
Sample size
Target sample size:
80
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Tehran University of Medical Sciences
Street address
Keshavarz BLV, Qods st, Tehran University of Medical Sciences
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
Intervention groups
1
Description
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 twice daily (50 mg/day). The dose was thereafter increased to 100 mg/day (50 mg in the morning and 50 mg in the evening). The maintenance phase began in the 4th week with the dose of 150mg/day. Finally the dose was tapered to 75 mg/day in the first week and 25mg/day in the second week up to either completion of or early withdrawal from the study.
Category
Treatment - Drugs
2
Description
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 subjects assigned to this group. In the second week, placebo tablet was administered at 25mg twice daily (50 mg/day). The dose was thereafter increased to 100 mg/day (50 mg in the morning and 50 mg in the evening). The maintenance phase began in the 4th week with the dose of 150mg/day. During the maintenance phase, the dose remained constant . Finally the dose was tapered to 75 mg/day in the first week and 25mg/day in the second week up to either completion of or early withdrawal from the study.
Category
Placebo
Recruitment centers
1
Recruitment center
Name of recruitment center
Endocrine and metabolism Research center, Firouzgar hospital
Full name of responsible person
Sedighe Moradi
Street address
Endocrine and metabolism Research center, Firouzgar hospital,Valiasr sq.
City
Tehran
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
Tehran University of Medical sciences
Full name of responsible person
Roghayeh Malmir
Street address
Keshavarz BLv, Qods st, Tehran University of Medical sciences, 5th floor, Research Unit
City
Tehran
Grant name
م-ت
Grant code / Reference number
131م-ت
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Tehran University of Medical sciences
Proportion provided by this source
100
Public or private sector
empty
Domestic or foreign origin
empty
Category of foreign source of funding
empty
Country of origin
Type of organization providing the funding
empty
Person responsible for general inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Sedighe Moradi
Position
Assistant professor
Other areas of specialty/work
Street address
Endocrine and metabolism Research center, Firouzgar hospital,Valiasr sq.
City
Tehran
Postal code
Phone
+98 21 2620 2448
Fax
Email
s-moradi@tums.ac.ir
Web page address
Person responsible for scientific inquiries
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Sedighe Moradi
Position
Assistant professor
Other areas of specialty/work
Street address
Endocrine and metabolism Research center, Firouzgar hospital,Valiasr sq.
City
Tehran
Postal code
Phone
+98 21 2620 2448
Fax
Email
s-moradi@tums.ac.ir
Web page address
Person responsible for updating data
Contact
Name of organization / entity
Tehran University of Medical Sciences
Full name of responsible person
Sedighe Moradi
Position
Assistant professor
Other areas of specialty/work
Street address
Endocrine and metabolism Research center, Firouzgar hospital,Valiasr sq.
City
Tehran
Postal code
Phone
Fax
Email
Web page address
Sharing plan
Deidentified Individual Participant Data Set (IPD)