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Could donating blood help control diabetes and fatty liver?

NCT ID NCT00230087

Disease control Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed This study
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 21, 2026 · Last updated Jul 22, 2026 · Updated 1 time

Summary

This study investigates whether reducing iron levels in the body through blood donation can improve insulin sensitivity and liver function in people with type 2 diabetes and non-alcoholic fatty liver disease. Participants will undergo phlebotomy until their iron stores are depleted. The goal is to see if this leads to better diabetes control and less fat in the liver.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
blood donation (phlebotomy) to reduce iron levels
What this could lead to
If it works, this could point toward a simple, low-cost way to improve diabetes control and reduce liver fat in people with type 2 diabetes and fatty liver disease.
What could go wrong
This is a very small early study with only 15 participants, so results may not apply to everyone. Lowering iron may not improve insulin sensitivity or liver health as hoped.

This is an AI summary of the original study and may miss details. Read our disclaimer.

Study facts

What this study's own registry entry says, in plain language.

Phase

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 15 people

The number the study aims to enrol. It can still change while the study runs.

Start date

Sep 2005

Finished

Jun 2010

Lead sponsor

A government research agency

The lead sponsor is the US National Institutes of Health.

Who can take part

This study's own entry requirements. Only the study team can say for certain whether you qualify.

Ages

18 to 65 years

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show the full entry requirements

Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.

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

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Conditions

The condition(s) this trial relates to.

diabetes mellitus metabolic dysfunction-associated steatotic liver disease type 2 diabetes mellitus

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Diabetes mellitus Non-alcoholic fatty liver disease

Contacts and locations

Locations

  • University of Washington Medical Center

    Seattle, Washington, 98195, United States

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