The Role of Leptin Receptors in NASH
This study has been completed.
Sponsor:
University of California, Davis
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
| Tracking Information | |||||
|---|---|---|---|---|---|
| First Received Date ICMJE | December 21, 2007 | ||||
| Last Updated Date | November 1, 2012 | ||||
| Start Date ICMJE | January 2006 | ||||
| Primary Completion Date | June 2009 (final data collection date for primary outcome measure) | ||||
| Current Primary Outcome Measures ICMJE |
To link SLR to grade/stage of NASH [ Time Frame: 2.5 years ] [ Designated as safety issue: No ] | ||||
| Original Primary Outcome Measures ICMJE | Same as current | ||||
| Change History | Complete list of historical versions of study NCT00583999 on ClinicalTrials.gov Archive Site | ||||
| Current Secondary Outcome Measures ICMJE |
To link SLR, leptin and adiponectin to features/components of the metabolic syndrome [ Time Frame: 2.5 years ] [ Designated as safety issue: No ] | ||||
| Original Secondary Outcome Measures ICMJE | Same as current | ||||
| Current Other Outcome Measures ICMJE | Not Provided | ||||
| Original Other Outcome Measures ICMJE | Not Provided | ||||
| Descriptive Information | |||||
| Brief Title ICMJE | The Role of Leptin Receptors in NASH | ||||
| Official Title ICMJE | Leptin, Soluble Leptin Receptor and Adiponectin in Non Alcoholic Steatohepatitis | ||||
| 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. |
||||
| Detailed Description | Not Provided | ||||
| Study Type ICMJE | Observational | ||||
| Study Design ICMJE | Observational Model: Cohort Time Perspective: Retrospective |
||||
| Target Follow-Up Duration | Not Provided | ||||
| Biospecimen | Retention: Samples With DNA Description: Liver biopsy specimes, serum |
||||
| Sampling Method | Probability Sample | ||||
| Study Population | Patients scheduled for bariatric surgery |
||||
| Condition ICMJE |
|
||||
| Intervention ICMJE | Other: no interventions, only regular blood-draw
No interventions, only regular blood-draw (liver biopsy obtained per routine during the surgery) |
||||
| Study Group/Cohort (s) | A
bariatric surgery
Intervention: Other: no interventions, only regular blood-draw |
||||
| Publications * | 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 nonalcoholic fatty liver disease. Obesity (Silver Spring). 2010 Dec;18(12):2268-73. Epub 2010 May 6. | ||||
|
* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
|||||
| Recruitment Information | |||||
| Recruitment Status ICMJE | Completed | ||||
| Enrollment ICMJE | 104 | ||||
| Completion Date | June 2009 | ||||
| Primary Completion Date | June 2009 (final data collection date for primary outcome measure) | ||||
| Eligibility Criteria ICMJE | Inclusion Criteria:
Exclusion Criteria:
|
||||
| Gender | Both | ||||
| Ages | 18 Years to 65 Years | ||||
| Accepts Healthy Volunteers | Yes | ||||
| Contacts ICMJE | Contact information is only displayed when the study is recruiting subjects | ||||
| Location Countries ICMJE | United States | ||||
| Administrative Information | |||||
| NCT Number ICMJE | NCT00583999 | ||||
| Other Study ID Numbers ICMJE | 2000513532 | ||||
| Has Data Monitoring Committee | Yes | ||||
| Responsible Party | Natalie J. Torok, University of California, Davis | ||||
| Study Sponsor ICMJE | University of California, Davis | ||||
| Collaborators ICMJE | Not Provided | ||||
| Investigators ICMJE |
|
||||
| Information Provided By | University of California, Davis | ||||
| Verification Date | November 2012 | ||||
|
ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
|||||