Insulin Resistance
Conditions
Keywords
insulin resistance
Brief summary
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. It is also hypothesized that moderate alcohol consumption impact insulin sensitivity and secretion with Latinos with or without HCV infection.
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. In addition, it is hypothesized that moderate alcohol consumption impacts insulin resistance and secretion and 30 patients with or without HCV who drink alcohol moderately will have discontinuation of alcohol use for 6 weeks and have metabolic testing before and after alcohol discontinuation.
Interventions
BEHAVIORALModerate alcohol cessation
patients will have moderate alcohol use discontinued for 6 weeks and have before and after alcohol cessation clinical and metabolic assessment and also patients with hepatitis C who have undergo therapy for hepatitis C may have repeat clinical and metabolic assessement
Sponsors
University of California, San Francisco
Study design
Observational model
COHORT
Time perspective
PROSPECTIVE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
Yes
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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| insulin resistance | baseline, 6 weeks and 18 months | steady state plasma glucose level (mg/dL) |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Insulin secretion | baseline, 6 weeks and 18 months | insulin secretion rate area under the curve (pmol/min) |
Countries
United States
Outcome results
None listed