Status:
COMPLETED
Iron Depletion Therapy for Type 2 DM and NAFLD
Lead Sponsor:
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Conditions:
Non-Alcoholic Fatty Liver Disease
Diabetes Mellitus
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief 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...
Detailed Description
Nonalcoholic fatty liver disease (NAFLD) is a common liver disease in the United States. NAFLD can lead to severe liver disease in some patients. Patients with NAFLD develop resistance to the normal a...
Eligibility Criteria
Inclusion
- 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 \<50μg/L
- Serum transferrin-iron saturation \<10 %
- Hemoglobin \<10 mg/L
- Hematocrit \<38 %
- Voluntary blood donation or therapeutic phlebotomy within the previous twelve months (except routine lab tests)
- Pregnant or lactating women
- Prior history of coronary artery disease, myocardial infarction, exertional dyspnea or chronic chest pain at rest.
- Evidence of myocardial infarction as determined by an ECG
Exclusion
Key Trial Info
Start Date :
September 1 2005
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
June 1 2010
Estimated Enrollment :
15 Patients enrolled
Trial Details
Trial ID
NCT00230087
Start Date
September 1 2005
End Date
June 1 2010
Last Update
November 7 2012
Active Locations (1)
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1
University of Washington Medical Center
Seattle, Washington, United States, 98195