Iron Depletion Therapy for Type 2 DM and NAFLD

NCT00230087 | Completed Phase 2 DMC

• 1 other identifier: DK 61728-S1 (completed)
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 1

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 and non-alcoholic fatty liver disease. This may result in better diabetes control and/or a decrease in the amount of liver fat.

Conditions

Non-Alcoholic Fatty Liver Disease; Diabetes Mellitus

Keywords

diabetes; nafld; nash; phlebotomy

Outcome Measures

Primary Outcomes (2)

• Improved insulin sensitivity as determined by:(1) hyperinsulinemic euglycemic clamp method

  one year

• (2) HOMA model- determined by the OGTT method

  one year

Secondary Outcomes (3)

• Change in serum aminotransferase levels Change in levels of serum, plasma and urinary markers of oxidative stress

  one year

• Changes in intrahepatic and intraabdominal fat content as determined by CT scan

  one year

• Change in serum levels of proinflammatory cytokines (ie IL-6, TnF-αR2)

  one year

Interventions

blood donation PROCEDURE

phlebotomy until iron depleted

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Hereditary hemochromatosis or hepatic iron overload defined as any of the following:
• + 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

Sponsors & Collaborators

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

Study Sites (1)

University of Washington Medical Center

Seattle, Washington, 98195, United States

Location

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease; Diabetes Mellitus

Interventions

Blood Donation

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Tissue and Organ Procurement; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Kris V Kowdley, MD

  University of Washington

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: NIH

Study Record Dates

• First Submitted: September 29, 2005
• First Posted: September 30, 2005
• Study Start: September 1, 2005
• Primary Completion: June 1, 2010
• Study Completion: June 1, 2010
• Last Updated: November 7, 2012

Record last verified: 2012-11

Locations

US (1)