Iron Depletion Therapy for Type 2 DM and NAFLD

Sex: All

Ages: 18 Years – 65 Years

Healthy volunteers: No

Phase: NA

Enrollment: 15

Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Summary

The purpose of this study is to find out whether lowering the amount of iron in the body will result in less resistance to insulin and improved liver function in patients with type 2 diabetes mellitus and non-alcoholic fatty liver disease. This may result in better diabetes control and/or a decrease in the amount of liver fat.

Eligibility Criteria

Inclusion Criteria * Histological evidence of NAFLD and enrollment in NASH CRN Database Study * Type 2 DM treated with diet or a stable dose of non-insulin sensitizing oral hypoglycemic agents for \> 3 mo. * Hemoglobin HbA1c level ≤ 8 % * Serum ALT levels ≥1.3 x ULN * Between 18-65 years of age Exclusion Criteria * Hereditary hemochromatosis or hepatic iron overload defined as any of the following: * 2+ iron on hepatic iron staining * Hepatic Iron Index ≥ 1.9 * C282Y homozygous or C282Y/H63D compound heterozygous HFE genotype * Use of insulin or thiazolidinediones for the treatment of diabetes * Use of anti-NASH drugs (thiazolidinediones, vitamin E, UDCA, SAM-e, betaine, milk thistle, gemfibrozil, anti-TNF therapies, probiotics) * Serum ferritin \

Interested in this study? View the official listing for contact and enrollment details.

View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT00230087). StuddyBuddy aggregates publicly available trial information.