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The Role of Leptin Receptors in NASH (NASH)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00583999
Recruitment Status : Completed
First Posted : January 2, 2008
Last Update Posted : May 30, 2017
Information provided by (Responsible Party):
University of California, Davis

Brief Summary:

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.

Condition or disease Intervention/treatment
Nonalcoholic Steatohepatitis Metabolic Syndrome Other: no interventions, only regular blood-draw

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Study Type : Observational
Actual Enrollment : 104 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Leptin, Soluble Leptin Receptor and Adiponectin in Non Alcoholic Steatohepatitis
Study Start Date : January 2006
Actual Primary Completion Date : June 2009
Actual Study Completion Date : June 2009

Group/Cohort Intervention/treatment
bariatric surgery
Other: no interventions, only regular blood-draw
No interventions, only regular blood-draw (liver biopsy obtained per routine during the surgery)

Primary Outcome Measures :
  1. To link SLR to grade/stage of NASH [ Time Frame: 2.5 years ]

Secondary Outcome Measures :
  1. To link SLR, leptin and adiponectin to features/components of the metabolic syndrome [ Time Frame: 2.5 years ]

Biospecimen Retention:   Samples With DNA
Liver biopsy specimes, serum

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 65 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Patients scheduled for bariatric surgery

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00583999

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United States, California
UC Davis Medical Center
Sacramento, California, United States, 95817
Sponsors and Collaborators
University of California, Davis
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Principal Investigator: Natalie Torok, MD UC Davis
Publications of Results:
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Responsible Party: University of California, Davis Identifier: NCT00583999    
Other Study ID Numbers: 2000513532
First Posted: January 2, 2008    Key Record Dates
Last Update Posted: May 30, 2017
Last Verified: May 2017
Keywords provided by University of California, Davis:
leptin, leptin receptors, adiponectin
Additional relevant MeSH terms:
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Fatty Liver
Non-alcoholic Fatty Liver Disease
Metabolic Syndrome
Insulin Resistance
Glucose Metabolism Disorders
Metabolic Diseases
Liver Diseases
Digestive System Diseases