Not Signed In -
Glyburide and Metformin |
Glucovance |
Clinical Trial: Double Blinded Randomised Trial Comparing Metformin Versus Placebo in NASH Patients Receiving Bariatric Surgery for Obesity
This study is currently recruiting patients.
Verified by University Hospital Ghent August 2005
|
Purpose
| Condition | Intervention | Phase |
|---|---|---|
| Obesity | Drug: Metformin versus placebo | Phase IV |
MedlinePlus related topics: Obesity
Study Type: Interventional
Study Design: Treatment, Randomized, Double-Blind, Placebo Control, Single Group Assignment, Efficacy Study
Further Study Details:
Primary Outcomes: Number of patients with histological amelioration of NASH after a period of 1 year
Secondary Outcomes: Number of patients with normalisation of ALT, steatosis on ultrasound after a period of 1 year
Expected Total Enrollment: 80
Secondary Outcomes: Number of patients with normalisation of ALT, steatosis on ultrasound after a period of 1 year
Expected Total Enrollment: 80
Study start: June 2005
Last follow-up: August 2005
In patients receiving bariatric surgery, a peroperative liver biopsy will confirm the presence of NASH. Those patients with NASH (histological defined according the Brunt''''s criteria) will be randomized to receive metformin (2 times 850 mg orally daily) or placebo for a time period of 1 year. A control liver biopsy will be performed after one year.
Eligibility
Genders Eligible for Study: Both
Criteria
Location and Contact Information
Please refer to this study by ClinicalTrials.gov identifier NCT00134303
Hans Van Vlierberghe, MD, PhD 0032/9/240.23.70 hans.vanvlierberghe@UGent.be
Belgium
University Hospital Ghent, Ghent, 9000, Belgium; Recruiting
Hans Van Vlierberghe, MD, PhD 0032/9/240.23.70 hans.vanvlierberghe@UGent.be
Study chairs or principal investigators
Hans Van Vlierberghe, MD, PhD, Principal Investigator, University Hospital Ghent
More Information
Website University Hospital Ghent
Study ID Numbers: 2005/045
Last Updated: August 23, 2005
Record first received: August 23, 2005
ClinicalTrials.gov Identifier: NCT00134303
Health Authority: Belgium: Directorate general for the protection of Public health: Medicines
ClinicalTrials.gov processed this record on 2005-08-30
Last Updated: August 23, 2005
Record first received: August 23, 2005
ClinicalTrials.gov Identifier: NCT00134303
Health Authority: Belgium: Directorate general for the protection of Public health: Medicines
ClinicalTrials.gov processed this record on 2005-08-30
email this page
print this page
bookmark this page
feedback on this page
