The Role of Leptin Receptors in NASH - Full Text View

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

Drug Information available for:

Leptin

U.S. FDA Resources

Study Type:	Observational
Study Design:	Cohort, Retrospective

Official Title:	Leptin, Soluble Leptin Receptor and Adiponectin in Non Alcoholic Steatohepatitis

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:

To link SLR, leptin and adiponectin to features/components of the metabolic syndrome [ Time Frame: 2.5 years ] [ Designated as safety issue: No ]

Biospecimen Retention: Samples With DNA

Biospecimen Description:

Liver biopsy specimes, serum

Estimated Enrollment:	120
Study Start Date:	January 2006
Estimated Study Completion Date:	June 2008
Estimated Primary Completion Date:	June 2008 (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

Ages Eligible for Study:	18 Years to 65 Years
Genders Eligible for Study:	Both
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

Please refer to this study by its ClinicalTrials.gov identifier: NCT00583999

Contacts


Contact: Natalie Torok, MD	916-734-3759	natalie.torok@ucdmc.ucdavis.edu

Locations


United States, California
	UC Davis Medical Center	Recruiting
	Sacramento, California, United States, 95817
	Contact: Natalie Torok, MD 916-734-3759 natalie.torok@ucdmc.ucdavis.edu
	Principal Investigator: Natalie Torok, MD

Sponsors and Collaborators

University of California, Davis

Investigators


Principal Investigator:	Natalie Torok, MD	UC Davis

More Information

Responsible Party:	University of California, Davis ( Natalie Torok, MD )
Study ID Numbers:	2000513532
First Received:	December 21, 2007
Last Updated:	December 21, 2007
ClinicalTrials.gov Identifier:	NCT00583999
Health Authority:	United States: Institutional Review Board

Keywords provided by University of California, Davis:

leptin, leptin receptors, adiponectin

Additional relevant MeSH terms:

Pathologic Processes

Disease

Syndrome

ClinicalTrials.gov processed this record on October 31, 2008

Sponsored by:	University of California, Davis
Information provided by:	University of California, Davis
ClinicalTrials.gov Identifier:	NCT00583999