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Trial record 19 of 328 for:    "nutrition disorders " [CONDITION] AND child [AGE-GROUP] | Open Studies
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Trial Comparing Metformin Versus Placebo in Non Alcoholic Steatohepatitis (NASH) Patients Receiving Bariatric Surgery for Obesity

This study is currently recruiting participants.
Verified January 2013 by University Hospital, Ghent
Sponsor:
Collaborator:
Merck
Information provided by (Responsible Party):
University Hospital, Ghent
ClinicalTrials.gov Identifier:
NCT00134303
First received: August 23, 2005
Last updated: January 29, 2013
Last verified: January 2013
History of Changes
  Purpose

This is a comparison of metformin versus placebo in NASH patients receiving bariatric surgery for obesity.


Condition Intervention Phase
Obesity
 Drug: Metformin
 Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Single Group Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
Official Title: Double Blinded Randomised Trial Comparing Metformin Versus Placebo in NASH Patients Receiving Bariatric Surgery for Obesity

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Hospital, Ghent:

Primary Outcome Measures:
  • Number of patients with histological amelioration of NASH after a period of 1 year [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Number of patients with normalisation of ALT, steatosis on ultrasound after a period of 1 year [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 200
Study Start Date: June 2005
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: July 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: NASH Drug: Metformin
Metformin is used.

Detailed Description:

In patients receiving bariatric surgery, a preoperative liver biopsy will confirm the presence of NASH. Those patients with NASH (histologically 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
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Patients receiving bariatric surgery for obesity

Exclusion Criteria:

  • Other causes of liver disease (hepatitis B virus [HBV], hepatitis C virus [HCV], primary biliary cirrhosis [PBC], etc.)
  • Patients with diabetes type I
  • Patients with endocrinological reasons for obesity (eg. Cushing, etc.)
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00134303

Contacts
Contact: Hans Van Vlierberghe, MD, PhD +32 9 332.23.70 hans.vanvlierberghe@UGent.be

Locations
Belgium
University Hospital Ghent Recruiting
Ghent, Belgium, 9000
Contact: Hans Van Vlierberghe, MD, PhD     + 32 9 332.23.70     hans.vanvlierberghe@UGent.be    
Sponsors and Collaborators
University Hospital, Ghent
Merck
Investigators
Principal Investigator: Hans Van Vlierberghe, MD, PhD University Hospital, Ghent
  More Information

Additional Information:
Website University Hospital Ghent  This link exits the ClinicalTrials.gov site

No publications provided

Responsible Party: University Hospital, Ghent
ClinicalTrials.gov Identifier: NCT00134303     History of Changes
Other Study ID Numbers: 2005/045
Study First Received: August 23, 2005
Last Updated: January 29, 2013
Health Authority: Belgium: Directorate general for the protection of Public health: Medicines

Additional relevant MeSH terms:
Nutrition Disorders
Obesity
Fatty Liver
Overnutrition
Overweight
Body Weight
Signs and Symptoms
 Liver Diseases
Digestive System Diseases
Metformin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 19, 2013