CompletedNot Applicable

Iron Depletion Therapy for Type 2 DM and NAFLD

United States15 participantsStarted 2005-09

Plain-language 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.

Who can participate

Age range

18 Years – 65 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

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

Timeframe: one year

(2) HOMA model- determined by the OGTT method

Timeframe: one year

Trial details

NCT IDNCT00230087

SponsorNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Sponsor typeNIH

Study typeINTERVENTIONAL

Primary completion2010-06

View on ClinicalTrials.gov More Non-Alcoholic Fatty Liver Disease trials