This randomized double blind controlled trial was performed to determine the effect of low-calorie diet with and without sibutramine on risk factors of metabolic syndrome and ultrasound findings in 40 patients with non-alcoholic fatty liver (confirmed by ultrasound). After 12-14 hours fasting, blood sample was taken and concentration of triglyceride, glucose, AST, ALT, HbA1c and serum ferritin, total cholesterol, HDL-c, and LDL-c are checked and weight and height of the patients were measured by standard methods. Then the patients were assigned receive 15-mg capsules of sibutramine daily half an hour before lunch as well as vitamin E supplements (400 IU) once a day and weight loss diet for 3 months or only vitamin E supplement (400 IU) once a day and weight loss diet for 3 months. At the end of the third month, the patients were again repeated the above mentioned measures.
General information
Acronym
IRCT registration information
IRCT registration number:IRCT201012275483N1
Registration date:2011-01-28, 1389/11/08
Registration timing:retrospective
Last update:
Update count:0
Registration date
2011-01-28, 1389/11/08
Registrant information
Name
Zahra Bahmanabadi
Name of organization / entity
School of health & nutrition -Aras International Unit
Country
Iran (Islamic Republic of)
Phone
+98 21 8873 7757
Email address
ysf@aut.ac.ir
Recruitment status
Recruitment complete
Funding source
Aras International University
Expected recruitment start date
2010-04-18, 1389/01/29
Expected recruitment end date
2010-09-01, 1389/06/10
Actual recruitment start date
empty
Actual recruitment end date
empty
Trial completion date
empty
Scientific title
The effect of low calorie diet with and without sibutramine on metabolic syndrome risk factors and sonographic findings in non alcoholic fatty liver
Public title
The effect of sibutramine on non alcoholic fatty liver
Purpose
Treatment
Inclusion/Exclusion criteria
Inclusion criteria: non-alcoholic fatty liver disease, having 20 to 50 years old of both sexes, having BMI 30kg/m2 or more, willing to participate
Exclusion criteria: Presence of thyroid disorders, diabetes, or uncontrolled hypertension, use of glucose, cholesterol, or triglyceride lowering drugs, estrogen or progesterone usage, supplementation of vitamin C, or E over the two months prior to the study, menopausal women, smoking and alcohol use, being athletes
Age
From 18 years old to 50 years old
Gender
Both
Phase
N/A
Groups that have been masked
No information
Sample size
Target sample size:
40
Randomization (investigator's opinion)
Randomized
Randomization description
Blinding (investigator's opinion)
Double blinded
Blinding description
Placebo
Not used
Assignment
Parallel
Other design features
Secondary Ids
empty
Ethics committees
1
Ethics committee
Name of ethics committee
Ethic Committee of Tabriz University of Medical Sciences
Street address
Tabriz University of Medical Sciences,Tabriz, Iran
City
Tabriz
Postal code
Approval date
2011-01-02, 1389/10/12
Ethics committee reference number
8949
Health conditions studied
1
Description of health condition studied
non alcoholic fatty liver
ICD-10 code
k70, k77
ICD-10 code description
Diseases of liver
Primary outcomes
1
Description
liver echogenicity
Timepoint
before and after intervention
Method of measurement
sonography
2
Description
weight
Timepoint
every two week
Method of measurement
Nestle scale
Secondary outcomes
1
Description
total cholestrol
Timepoint
at the beginning and end of the intervation
Method of measurement
enzymatic method with autoanalysis system
2
Description
lDL-C
Timepoint
at the beginning and end of the intervation
Method of measurement
enzymatic method with autoanalysis system
3
Description
HDL-C
Timepoint
at the beginning and end of the intervation
Method of measurement
enzymatic method with autoanalysis system
4
Description
Glucose
Timepoint
at the beginning and end of the intervation
Method of measurement
enzymatic method with autoanalysis system
5
Description
AST
Timepoint
at the beginning and end of the intervation
Method of measurement
ELISA
6
Description
ALT
Timepoint
at the beginning and end of the intervation
Method of measurement
spectrophotometery
7
Description
ferritin
Timepoint
at the beginning and end of the intervation
Method of measurement
ELISA
8
Description
HbA1c
Timepoint
at the beginning and end of the intervation
Method of measurement
ELISA
9
Description
Trigliceride
Timepoint
at the beginning and end of the intervation
Method of measurement
enzymatic method with autoanalysis system
Intervention groups
1
Description
Control group: vitamin E 400 IU supplement once daily and weight loss diet for 3 months
Category
Treatment - Drugs
2
Description
Intervention group: 15-mg capsule of sibutramine once a day half an hour before lunch and vitamin E supplement (400 IU) once a day and weight loss diet for 3 months
Category
Treatment - Drugs
Recruitment centers
1
Recruitment center
Name of recruitment center
Sheikhalrayis clinic
Full name of responsible person
Dr. Mehrangiz Ebrahimimamagani
Street address
Sheikhalrayis clinic, Golbad street
City
Tabriz
Sponsors / Funding sources
1
Sponsor
Name of organization / entity
School of health & nutrition, Aras international university
Full name of responsible person
Mr. Farshidi
Street address
Tabriz University of Medical Sciences, Tabriz
City
Tabriz
Grant name
Grant code / Reference number
Is the source of funding the same sponsor organization/entity?
Yes
Title of funding source
School of health & nutrition, Aras international university
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
School of health and nutrition, Aras International University
Full name of responsible person
Zahra Bahmanabadi
Position
student of master science on nutrition
Other areas of specialty/work
Street address
School of health and nutrition, Tabriz University of Medical Sciences