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The Role of Leptin Receptors in NASH (NASH)

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00583999
First Posted: January 2, 2008
Last Update Posted: May 30, 2017
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.
Information provided by (Responsible Party):
University of California, Davis
  Purpose

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 Intervention
Nonalcoholic Steatohepatitis Metabolic Syndrome Other: no interventions, only regular blood-draw

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Leptin, Soluble Leptin Receptor and Adiponectin in Non Alcoholic Steatohepatitis

Resource links provided by NLM:


Further study details as provided by University of California, Davis:

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

Secondary Outcome Measures:
  • 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

Enrollment: 104
Study Start Date: January 2006
Study Completion Date: June 2009
Primary Completion Date: June 2009 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
A
bariatric surgery
Other: no interventions, only regular blood-draw
No interventions, only regular blood-draw (liver biopsy obtained per routine during the surgery)

  Eligibility

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 Submitted: December 21, 2007
First Posted: January 2, 2008
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