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Blood donation may improve diabetes and fatty liver, study finds

NCT ID NCT03696797

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 Results may not be published yet.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This status has not been confirmed recently, so it may be out of date.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 Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 1 time

Summary

This study tested whether regularly removing blood (like donating blood) can lower iron levels and improve diabetes control and fatty liver disease. 132 adults aged 40-75 with prediabetes or diabetes took part. The treatment group gave blood several times, while the control group did not. Researchers measured blood sugar, liver enzymes, and insulin function over 6 to 12 months.

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)
What this could lead to
If it works, this could offer a simple, low-cost way to improve blood sugar control and liver health in people with diabetes and fatty liver disease.
What could go wrong
This is a completed trial with 132 participants, so results are limited. The intervention (blood donation) may not be effective for everyone, and risks include anemia or dehydration from blood draws.

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

132 people

The number who actually took part.

Started

May 2019

Finished

Jan 2025

Lead sponsor

Other sponsor

The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.

Who can take part

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

Ages

40 to 75 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: * Ages 40-75 * At least 3 months since diagnosis of prediabetes or diabetes * HgbA1C value within three months or at screening of 5.7-6.4% for those with prediabetes and 7- 8.5% for those with diabetes (the upper limit of the latter to reduce the likelihood of major changes in glycemic intervention during the trial period, and the lower limit to allow some room for improvement) * Undiagnosed on no medication HgA1C 6.5-6.9 * C-reactive protein levels up to 11.0 * Aim 2-serum ALT\> 1.5 times the upper limit of normal, or; liver stiffness of \> 12.5 kPa by Fibroscan transient elastography * Serum ferritin levels within 1 year or at the time of screening in the upper half of the normal range (\>50 ng/mL for women; \>100ng/mL for men) Exclusion Criteria: * Documented anemia * Hemoglobin levels within 0.5 g/dL of the lower limit of normal (\<12.5 g/dL for women; 13.5 g/dL for men) * Recent blood loss * Bleeding diatheses (coagulation abnormalities or treatment with anticoagulants) * Serious chronic infections or chronic inflammatory conditions that could elevate ferritin as an "acute phase reactant * C-reactive protein greater than the upper limit of normal to further validate the lack of significant chronic inflammation * Active cancer diagnosis (excluding skin cell cancers other than melanoma) * Renal insufficiency (eGFR\<60 ml/min) * History of orthostatic hypotension * Heavy alcohol use (NIH criteria for men, greater than 4 drinks on any day or 14/week) * Pregnancy or premenopausal women of childbearing age, unless unable to become pregnant because of oral contraceptive use or surgical loss of ovaries or uterus * Aim 2 - individuals meeting the additional inclusion criteria for aim 2 will be tested for anti-HAV IgM, HBs Ag, anti-HBc. IgM, anti HCV IgM and IgG. Subjects who prove positive for any of these viral serologies, except for HCV IgG will be excluded. The latter will be tested for HCV RNA by PRC, and if negative they will be eligible for enrollment

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Conditions

The condition(s) this trial relates to.

As listed by the trial registrant

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

Contacts and locations

Locations

  • University of North Carolina at Chapel Hill (UNC)

    Chapel Hill, North Carolina, 27599-2100, United States

  • Wake Forest University Health Sciences

    Winston-Salem, North Carolina, 27157, United States

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