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Completed

NCT Number: NCT00134303

Trial Comparing Metformin Versus Placebo in Non Alcoholic Steatohepatitis (NASH) Patients Receiving Bariatric Surgery for Obesity

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

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Key information

Conditions

Obesity Body Weight Nutrition Disorders Nutritional and Metabolic Diseases Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

University Hospital Ghent

Ghent, 9000, Belgium

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.)

Treatment and study plan

metformin

Drug

Metformin is used.

Primary outcomes

  1. Number of patients with histological amelioration of NASH after a period of 1 year

    Time frame: 1 year

Secondary outcomes

  1. Number of patients with normalisation of ALT, steatosis on ultrasound after a period of 1 year

    Time frame: 1 year

Sponsors and collaborators

Lead sponsor

University Hospital, Ghent

Other

Collaborators

  • Merck Sharp & Dohme LLC

Registry information

Official study title

Double Blinded Randomised Trial Comparing Metformin Versus Placebo in NASH Patients Receiving Bariatric Surgery for Obesity

Important dates

Study start
2005
Primary completion
2006
Study completion
2006
First posted
Aug 24, 2005
Registry last updated
Dec 8, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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