| Trial ID: | L0957 |
| Source ID: | IRCT201012275483N1
|
| Associated Drug: |
Sibutramine
|
| Title: |
The effect of low calorie diet with and without sibutramine on metabolic syndrome risk factors and sonographic findings in non alcoholic fatty liver
|
| Acronym: |
--
|
| Status: |
Not Recruiting
|
| Study Results: |
No Results Available
|
| Results: |
--
|
| Conditions: |
non alcoholic fatty liver. <br>Diseases of liver;k70, k77;Diseases of liver
|
| Interventions: |
Intervention 1: Control group: vitamin E 400 IU supplement once daily and weight loss diet for 3 months. Intervention 2: 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
|
| Outcome Measures: |
Liver echogenicity. Timepoint: before and after intervention. Method of measurement: sonography.;Weight. Timepoint: every two week. Method of measurement: Nestle scale.Total cholestrol. Timepoint: at the beginning and end of the intervation. Method of measurement: enzymatic method with autoanalysis system.;LDL-C. Timepoint: at the beginning and end of the intervation. Method of measurement: enzymatic method with autoanalysis system.;HDL-C. Timepoint: at the beginning and end of the intervation. Method of measurement: enzymatic method with autoanalysis system.;Glucose. Timepoint: at the beginning and end of the intervation. Method of measurement: enzymatic method with autoanalysis system.;AST. Timepoint: at the beginning and end of the intervation. Method of measurement: ELISA.;ALT. Timepoint: at the beginning and end of the intervation. Method of measurement: spectrophotometery.;Ferritin. Timepoint: at the beginning and end of the intervation. Method of measurement: ELISA.;HbA1c. Timepoint: at the beginning and end of the intervation. Method of measurement: ELISA.;Trigliceride. Timepoint: at the beginning and end of the intervation. Method of measurement: enzymatic method with autoanalysis system.
|
| Sponsor/Collaborators: |
School of health & nutrition, Aras international university
|
| Gender: |
All
|
| Age: |
18 years50 years
|
| Phases: |
Not applicable
|
| Enrollment: |
40
|
| Study Type: |
interventional
|
| Study Designs: |
Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment.
|
| Start Date: |
28/01/2011
|
| Completion Date: |
--
|
| Results First Posted: |
--
|
| Last Update Posted: |
22 February 2018
|
| Locations: |
Iran (Islamic Republic of)
|
| URL: |
http://en.irct.ir/trial/5879
|
