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The Role of Leptin Receptors in NASH (NASH)

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ClinicalTrials.gov Identifier: NCT00583999
Recruitment Status : Completed
First Posted : January 2, 2008
Last Update Posted : May 30, 2017
Sponsor:
Information provided by (Responsible Party):

Study Description
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

Study Design

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
Primary Completion Date : June 2009
Study Completion Date : June 2009


Groups and Cohorts

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


Outcome Measures

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

Eligibility Criteria

Information from the National Library of Medicine

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

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.
Contacts and Locations

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 ClinicalTrials.gov identifier (NCT number): NCT00583999


Locations
United States, California
UC Davis Medical Center
Sacramento, California, United States, 95817
Sponsors and Collaborators
University of California, Davis
Investigators
Principal Investigator: Natalie Torok, MD UC Davis
More Information

Publications:
Responsible Party: University of California, Davis
ClinicalTrials.gov Identifier: NCT00583999     History of Changes
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:
Metabolic Syndrome X
Fatty Liver
Non-alcoholic Fatty Liver Disease
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Liver Diseases
Digestive System Diseases