Trial record 4 of 206 for:    nash

The Role of Leptin Receptors in NASH

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Natalie J. Torok, University of California, Davis
ClinicalTrials.gov Identifier:
NCT00583999
First received: December 21, 2007
Last updated: November 1, 2012
Last verified: November 2012
  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 ] [ 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

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

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

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: Natalie J. Torok, Principal Investigator, University of California, Davis
ClinicalTrials.gov Identifier: NCT00583999     History of Changes
Other Study ID Numbers: 2000513532
Study First Received: December 21, 2007
Last Updated: November 1, 2012
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, Davis:
leptin, leptin receptors, adiponectin

Additional relevant MeSH terms:
Metabolic Syndrome X
Fatty Liver
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Liver Diseases
Digestive System Diseases

ClinicalTrials.gov processed this record on April 17, 2014