Protocol summary

Summary
This study was a double-blind randomized controlled clinical trial. From all obese patients referred to the endocrinology clinic of Afzalipour hospital and office for treatment, 66 non diabetic subjects were recruited to this study. Inclusion criteria were age equal or more than 18 years, willingness to participate in the study, BMI (weight[kg]/ height[m]2 ) between 25-35, no evidence of cardiovascular disease, diabetes, gastrointestinal disease (IBD, intestinal ulcers, bowel obstruction), liver disease and renal disease, no history of medication for lowering weight, women should not be pregnant or milking. The exclusion criteria were no desire to continue the treatment, development of renal, gastrointestinal and liver disease during treatment and beginning to utilize antihypertensive drugs such as β blocker and thiazides. At the beginning of study, the baseline characteristics of all selected subjects including height, weight, total cholesterol, and triglyceride (TG) and fasting blood glucose (FBS) were recorded. Patients were randomly assigned to receive acarbose or placebo. Randomization was performed centrally by a computer program with minimization for height, weight and BMI according to the study center. Treatment group was given acarbose pills (100mg) and other group took lactose contained placebo (100mg). Patients were given study medication1.5 tablets daily for the first two weeks and 3 tablets per day afterwards. Subjects were evaluated every month for adverse effects, weight loss and BMI for five months. At the baseline and once every three months blood samples for FBS, TG and Cholesterol were taken from patients

General information

Acronym
IRCT registration information
IRCT registration number: IRCT201011151774N3
Registration date: 2010-12-29, 1389/10/08
Registration timing: retrospective

Last update:
Update count: 0
Registration date
2010-12-29, 1389/10/08
Registrant information
Name
Mojgan Sanjari
Name of organization / entity
Kerman University of Medical Science
Country
Iran (Islamic Republic of)
Phone
+98 34 1322 2506
Email address
msanjari@kmu.ac.ir
Recruitment status
Recruitment complete
Funding source
Kerman medical university; Excir company
Expected recruitment start date
2009-03-21, 1388/01/01
Expected recruitment end date
2010-03-21, 1389/01/01
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
Evaluation of effect of acarbose consumption on weight loosing in nondiabetic obese patients in Kerman
Public title
acrabose effect on weight loseing
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria were age equal or more than 18 years, willingness to participate in the study, BMI (weight[kg]/ height[m]2 ) between 25-35, no evidence of cardiovascular disease, diabetes, gastrointestinal disease (IBD, intestinal ulcers, bowel obstruction), liver disease and renal disease, no history of medication for lowering weight, women should not be pregnant or milking. The exclusion criteria were no desire to continue the treatment, development of renal, gastrointestinal and liver disease during treatment and beginning to utilize antihypertensive drugs such as β blocker and thiazides.
Age
From 18 years old to 149 years old
Gender
Both
Phase
2-3
Groups that have been masked
No information
Sample size
Target sample size: 66
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
Kerman medical univercity ethics committe
Street address
Kerman Jomhori ave. Kerman medical univercity
City
Kerman
Postal code
Approval date
2009-07-24, 1388/05/02
Ethics committee reference number
k/88/106

Health conditions studied

1

Description of health condition studied
overweight
ICD-10 code
E66.9
ICD-10 code description
Obesity, unspecified

Primary outcomes

1

Description
BMI
Timepoint
monthly
Method of measurement
meter and weighting scale

Secondary outcomes

1

Description
Fbs, TG, Cholestrol
Timepoint
every three mounth
Method of measurement
lab test

Intervention groups

1

Description
placebo three tablets daily
Category
Placebo

2

Description
acarbose tablet 100 mg three tablets daily
Category
Treatment - Drugs

Recruitment centers

1

Recruitment center
Name of recruitment center
Afzali Pour hospital
Full name of responsible person
Dr Akram Nakhaee
Street address
City
Kerman

Sponsors / Funding sources

1

Sponsor
Name of organization / entity
Kerman medical university
Full name of responsible person
Dr Hamid Najafipour
Street address
Kerman, Kerman medical university
City
Kerman
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Kerman medical university
Proportion provided by this source
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

2

Sponsor
Name of organization / entity
Excir company
Full name of responsible person
Romiia Javadi
Street address
22, Rahmati alley, Valiasr Ave
City
Tehran
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
Excir company
Proportion provided by this source
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
Kerman Medical university
Full name of responsible person
Dr Akram Nakhaee
Position
general physician
Other areas of specialty/work
Street address
Kerman ,Kerman Medical university
City
Kerman
Postal code
Phone
+98 34 1245 3189
Fax
Email
anakheai@gmail.com
Web page address

Person responsible for scientific inquiries

Contact
Name of organization / entity
kerman medical university
Full name of responsible person
Dr Mojgan Sanjari
Position
Endocrinologist
Other areas of specialty/work
Street address
Kerman, Kerman Medical university
City
Kerman
Postal code
Phone
+98 34 1322 2250
Fax
Email
msanjari@kmu.ac.ir
Web page address

Person responsible for updating data

Contact
Name of organization / entity
Kerman Medical University
Full name of responsible person
Dr Akram Nakhaee
Position
general physician
Other areas of specialty/work
Street address
Kerman, Kerman Medical University
City
Kerman
Postal code
Phone
Fax
Email
Web page address

Sharing plan

Deidentified Individual Participant Data Set (IPD)
empty
Study Protocol
empty
Statistical Analysis Plan
empty
Informed Consent Form
empty
Clinical Study Report
empty
Analytic Code
empty
Data Dictionary
empty
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