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NCT00583999 Clinical Trial

The Role of Leptin Receptors in NASH

Metabolic Syndrome Clinical Trial

— NASH  

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00583999
Other study ID # 2000513532
Secondary ID
Status Completed
Phase N/A
First received December 21, 2007
Last updated May 25, 2017
Start date January 2006
Est. completion date June 2009

Study information
Verified date May 2017
Source University of California, Davis
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 104
Est. completion date June 2009
Est. primary completion date June 2009
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 18 Years to 65 Years
Eligibility 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.

Study Design

Related Conditions & MeSH terms

Intervention

Other:
• no interventions, only regular blood-draw
No interventions, only regular blood-draw (liver biopsy obtained per routine during the surgery)

Locations
Country Name City State
United States UC Davis Medical Center Sacramento California

Sponsors (1)
Lead Sponsor Collaborator
University of California, Davis

Country where clinical trial is conducted

United States, 

References & Publications (1)

Medici V, Ali MR, Seo S, Aoki CA, Rossaro L, Kim K, Fuller WD, Vidovszky TJ, Smith W, Jiang JX, Maganti K, Havel PJ, Kamboj A, Ramsamooj R, Török NJ. Increased soluble leptin receptor levels in morbidly obese patients with insulin resistance and nonalcoho — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary To link SLR to grade/stage of NASH 2.5 years
Secondary To link SLR, leptin and adiponectin to features/components of the metabolic syndrome 2.5 years
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