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Completed

NCT Number: NCT00886301

Fatty Liver and Ectopic Fat in Overweight and Obese Patients

The aim of the study is to find new clinico-biological and medical imaging parameters associated with non alcoholic steatohepatitis in overweight and obese patients.

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Key information

Conditions

Steatohepatitis Body Weight Digestive System Diseases Fatty Liver Liver Diseases Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Hepatogastroenterology, Hôpital l'Archet, CHU de Nice

Nice, 06000, France

About this study

Non invasive assessment of liver fibrosis and liver inflammation and steatosis is clinically relevant in patients exposed to non alcoholic fatty liver diseases.

The aim of the study is to find new clinico-biological and medical imaging parameters associated with non alcoholic steatohepatitis in overweight and obese patients.

Fatty liver and ectopic fat accumulation will be particularly assessed.

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • BMI between 25 and 40
  • ALAT level superior to normal level even after 3 months of diet
  • alcohol consumption < 20 g/j for women and < 30 g/j for men

Exclusion criteria

  • HIV, hepatitis B virus, hepatitis C virus positive
  • known hemochromatosis
  • glycemia > 1.26 g/L or under anti-diabetic treatment

Treatment and study plan

Liver biopsy

Procedure

liver biopsy

Primary outcomes

  1. Liver status will be will be determined by liver biopsy, non invasive liver assessment. Biological and medical imaging parameters will be use to characterize our patients.

    Time frame: at inclusion and at year 1

Secondary outcomes

  1. Non invasive liver assessment, biological and medical imaging parameters will be use to characterize our patients.

    Time frame: at year 1

Sponsors and collaborators

Lead sponsor

Centre Hospitalier Universitaire de Nice

Other

Registry information

Important dates

Study start
2010
Primary completion
2014
Study completion
2014
First posted
Apr 22, 2009
Registry last updated
Nov 13, 2023

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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