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OpenTrials
Completed

NCT Number: NCT00583999

The Role of Leptin Receptors in NASH

NAFLD is a spectrum of liver diseases associated with varying degrees of hepatic steatosis, inflammation, and in some cases, fibrosis. NAFLD is a common observation in all demographics, but the prevalence of NAFLD and nonalcoholic steatohepatitis (NASH) is especially high in the morbidly obese population. Leptin is a cytokine that is encoded by the ob gene and primarily secreted by adipose tissue. The production of serum leptin increases with progressive obesity. Because of this observation, there has been significant interest in potential role of leptin in NAFLD.

Our hypothesis is that we will find increased hepatic leptin and leptin receptor expression as the degree of hepatic injury worsens in NAFLD.

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Key information

Age range

18 year–65 year

Sex eligibility

All sexes

Study type

Observational

Primary location

UC Davis Medical Center

Sacramento, California, 95817, United States

Who can participate

Healthy volunteers accepted: Yes

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

Inclusion criteria

  • All patients undergoing elective bariatric surgery, ages 18-65.

Exclusion criteria

  • non-obese patients, ages less than 18 and over 65. Pregnant patients.

Treatment and study plan

no interventions, only regular blood-draw

Other

No interventions, only regular blood-draw (liver biopsy obtained per routine during the surgery)

Primary outcomes

  1. To link SLR to grade/stage of NASH

    Time frame: 2.5 years

Secondary outcomes

  1. To link SLR, leptin and adiponectin to features/components of the metabolic syndrome

    Time frame: 2.5 years

Sponsors and collaborators

Lead sponsor

University of California, Davis

Other

Registry information

Official study title

Leptin, Soluble Leptin Receptor and Adiponectin in Non Alcoholic Steatohepatitis

Acronym: NASH

Important dates

Study start
2006
Primary completion
2009
Study completion
2009
First posted
Jan 2, 2008
Registry last updated
May 30, 2017

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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