Trial record 5 of 902 for:    Open Studies | "Insulin"

Insulin Resistance in HCV Infection

This study is currently recruiting participants.
Verified January 2014 by University of California, San Francisco
Sponsor:
Information provided by (Responsible Party):
University of California, San Francisco
ClinicalTrials.gov Identifier:
NCT01858012
First received: May 16, 2013
Last updated: January 15, 2014
Last verified: January 2014
  Purpose

The study hypothesis is that the means by which HCV induces glucose intolerance is through impairment of B-cell function and compensatory hyperinsulinemia in predisposed Latinos with insulin resistance and that HCV eradication improves these abnormalities.


Condition
Insulin Resistance

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Impact of Hepatitis C on Insulin Sensitivity and Insulin Secretion in Latinos

Resource links provided by NLM:


Further study details as provided by University of California, San Francisco:

Primary Outcome Measures:
  • insulin resistance [ Time Frame: 18 months ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

serum samples for analysis


Estimated Enrollment: 150
Study Start Date: May 2008
Estimated Study Completion Date: March 2015
Estimated Primary Completion Date: March 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
HCV infection
patients with hepatitis C infection
non-HCV infection
healthy controls

Detailed Description:

The study hypothesis is that the means by which HCV induces glucose intolerance is through impairment of B-cell function and compensatory hyperinsulinemia in predisposed Latinos with insulin resistance and that HCV eradication improves these abnormalities. This study addresses changes in the metabolic parameters over time.

  Eligibility

Ages Eligible for Study:   18 Years to 60 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

Latinos with and without HCV infection

Criteria

Inclusion criteria for HCV participants:

  • Male or female patients between 18 and 60 years of age
  • Body mass index (BMI) > 20 Kg/m2
  • Serologic evidence of hepatitis C infection by anti-HCV antibody
  • Detectable plasma HCV-RNA
  • Compensated liver disease with the following minimum biochemical parameters: prothrombin time < 2 seconds prolonged compared to control and bilirubin < 3 mg/dL
  • Willingness to provide informed consent

Inclusion criteria for healthy Latino volunteers (without HCV infection):

-Same inclusion criteria as above except no evidence of HCV infection (anti-HCV antibody negative)

Inclusion criteria for participation in 6-week alcohol abstinence follow-up testing:

-Latinos who are moderate1 alcohol drinkers (1NIAAA definition: female: no more than 3 drinks on any day & no more than 7 drinks per week; male: no more than 4 drinks on any day and no more than 14 drinks per week).

Steady-State Plasma Glucose < 180 mg/dL

Exclusion criteria:

  • Hepatitis B or HIV infection
  • Subjects with liver disease other than that caused by HCV
  • Known history of diabetes, or fasting plasma glucose concentration >126 mg/dl
  • Known history of cirrhosis of the liver, as well as individuals with decompensated liver disease such as those with ascites, variceal bleeding, and encephalopathy
  • Known history of pancreatitis
  • Prior or current treatment for HCV
  • Heavy alcohol use (>80 g/d)
  • Subjects of lipid lowering agents, steroid/ anabolic therapy
  • Significant medical illness that would interfere with the completion of the study

Exclusion criteria for healthy (non HCV) Latino volunteers:

-Same as above, including subjects with HCV infection

  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01858012

Contacts
Contact: Mandana Khalili, MD 2064766 mandana.khalili@ucsf.edu

Locations
United States, California
University of California San Francisco Recruiting
San Francisco, California, United States
Principal Investigator: mandana Khalili         
University of California San Francisco Recruiting
San Francisco, California, United States, 94110
Contact: Mandana Khalili    415-206-4766      
University of california San Francisco Recruiting
San Francisco, California, United States, 94110
Contact: mandana Khalili    415-206-4766      
Sponsors and Collaborators
University of California, San Francisco
Investigators
Principal Investigator: Mandana Khalili, MD University of California, San Francisco
  More Information

No publications provided

Responsible Party: University of California, San Francisco
ClinicalTrials.gov Identifier: NCT01858012     History of Changes
Other Study ID Numbers: UCSF 10-00922
Study First Received: May 16, 2013
Last Updated: January 15, 2014
Health Authority: United States: Institutional Review Board

Keywords provided by University of California, San Francisco:
insulin resistance

Additional relevant MeSH terms:
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Insulin
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions

ClinicalTrials.gov processed this record on April 15, 2014