Blood Donation for Non-alcoholic Fatty Liver Disease

No longer recruiting at 1 trial location

Overseen By Audrey Bell-Farrow, MBA, MHA

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Wake Forest University Health Sciences

Must not be taking: Anticoagulants

Disqualifiers: Anemia, Cancer, Renal insufficiency, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Approved in 3 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

Duration: 12 months

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether donating blood, also known as Blood Donation Therapy or Phlebotomy, can help manage diabetes and reduce related issues like fatty liver disease. Participants will either donate blood or undergo a similar procedure without actual blood donation, ensuring neither group knows their assignment. This study suits individuals aged 40-75 who have had prediabetes or diabetes for at least three months and experience related liver conditions. As an unphased trial, it offers a unique opportunity to contribute to groundbreaking research that could improve diabetes management.

Do I need to stop my current medications for this trial?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that donating blood is generally safe for most people. Many donate to help others, and the process is well-understood. Before donation, staff checks your blood to ensure you are not anemic and not dehydrated. After donating, you receive a sports drink to help replace lost fluids.

One study found that for people with non-alcoholic fatty liver disease (NAFLD), donating blood reduced insulin resistance and improved liver health. This suggests that blood donation can positively affect the body, especially for those with certain health conditions.

Overall, blood donation is usually well-tolerated. Common side effects include feeling lightheaded or tired, but these are typically mild and resolve quickly. If you have concerns, discuss them with the trial team or your doctor before participating. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Unlike standard treatments for non-alcoholic fatty liver disease (NAFLD) that primarily focus on lifestyle changes like diet and exercise, blood donation offers a novel approach by potentially reducing iron levels in the body. High iron levels can worsen liver damage, so this method might help alleviate liver stress. Researchers are excited because this treatment is simple, non-pharmacological, and could provide a quick way to improve liver health without the side effects of medications.

What evidence suggests that blood donation might be an effective treatment for fatty liver disease?

In this trial, participants will join either a treatment group or a control group. The treatment group will undergo blood donation (phlebotomy). Previous studies have found that this can help people with non-alcoholic fatty liver disease (NAFLD) by improving insulin use and lowering levels of liver damage markers. One study found that giving blood improved the balance of fats in the blood, which is important for heart health. However, some research showed that blood donation did not significantly change insulin use, liver damage markers, or liver health. Researchers believe the treatment works by lowering iron levels in the body, which might help manage diabetes and liver problems. Meanwhile, the control group will undergo a sham blood donation procedure. ^{1 3 4 6 7}

Who Is on the Research Team?

Donald A McClain, MD

Principal Investigator

Wake Forest University Health Sciences

Are You a Good Fit for This Trial?

Adults aged 40-75 with prediabetes or diabetes, having specific levels of hemoglobin A1C and serum ferritin. They should not have severe kidney issues, heavy alcohol use, bleeding disorders, low blood pressure when standing up, recent significant blood loss, pregnancy (unless unable to become pregnant), active cancer (except certain skin cancers), or chronic infections/inflammatory conditions.

Inclusion Criteria

Your HgbA1C levels are between 5.7% and 6.4% if you have prediabetes, and between 7% and 8.5% if you have diabetes.

I am between 40 and 75 years old.

Your C-reactive protein levels are higher than 11.0.

Exclusion Criteria

I have a chronic infection or inflammation that could affect my ferritin levels.

I have a bleeding disorder or am on blood thinners.

I am not pregnant or able to become pregnant due to contraception or surgery.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo phlebotomy to reduce iron levels, with glucose control monitored through standard blood tests and continuous glucose monitoring

12 months

Monthly visits for blood tests and monitoring

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

Optional Substudies

Participants may opt into substudies focusing on liver complications and glucose tolerance mechanisms

Concurrent with main study

What Are the Treatments Tested in This Trial?

Interventions

• Blood Donation
• Sham Blood Donation

Trial Overview The study is testing whether reducing iron in the body through blood donation can improve diabetes control and reduce problems like fatty liver disease. Participants will either donate blood or undergo a sham procedure without actual donation to compare effects.

How Is the Trial Designed?

Group I: Treatment Group Active Control 1 Intervention

Will have a Unit of blood (two cups, the same amount donated at the Red Cross) drawn. This involves having a needle inserted into a vein in your arm. Prior to taking the blood, staff will measure your blood count to be sure you are not anemic, and blood pressure to be sure no dehydration. During or after donation, a sports drink is provided to replace the fluid loss. Phlebotomy

Group II: Control Group Placebo Group 1 Intervention

Will not donate blood, but will have a needle inserted into a vein in your arm. Both groups will not know which group assignment they have been randomized. Sham Phlebotomy

Blood Donation is already approved in United States, European Union, Canada for the following indications:

Approved in United States as Blood Donation for:

• Iron overload
• Polycythemia vera
• Porphyria cutanea tarda

Approved in European Union as Blood Donation for:

• Iron overload
• Polycythemia vera
• Porphyria cutanea tarda

Approved in Canada as Blood Donation for:

• Iron overload
• Polycythemia vera
• Porphyria cutanea tarda

Who Is Running the Clinical Trial?

Wake Forest University Health Sciences

Lead Sponsor

Trials

1,432

Recruited

2,506,000+

University of North Carolina, Chapel Hill

Collaborator

Trials

1,588

Recruited

4,364,000+

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

Collaborator

Trials

2,513

Recruited

4,366,000+

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5184740/

Outcome of Phlebotomy for Treating Nonalcoholic Fatty Liver ... Phlebotomy decreased insulin resistance and liver transaminase levels in patients with NAFLD. In addition, it improved their lipid profile.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT03696797?tab=history&a=6

Record History | ver. 6: 2019-05-02 | NCT03696797 This is a treatment study to determine if reducing the body's iron stores by blood donation will improve diabetes control and other problems associated with ...

3. researchgate.net researchgate.net/publication/365162545_Outcome_of_Phlebotomy_on_Improvement_of_Liver_Enzymes_and_Steatosis_in_Non-Alcoholic_Fatty_Liver_Disease_A_Randomized_Controlled_Trial

Outcome of Phlebotomy on Improvement of Liver Enzymes ... Conclusions: Phlebotomy does not bring about significant improvement in indices of insulin resistance, liver enzymes or liver histology in ...

4. frontiersin.org frontiersin.org/journals/medicine/articles/10.3389/fmed.2021.693997/full

Exposure to Plasma From Non-alcoholic Fatty Liver ... The results obtained shown that plasma of NAFLD patients was able to reduce cell viability and mitochondrial membrane potential by about 48 and ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S2589555921000987

Non-alcoholic fatty liver disease: A patient guideline This patient guideline is intended for all patients at risk of or living with non-alcoholic fatty liver disease (NAFLD).

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC6429343/

Noninvasive evaluation of nonalcoholic fatty liver disease This review discusses the current noninvasive methods for assessing NAFLD, including steatosis, NASH, and NAFLD-related fibrosis, and explores the advantages ...

7. withpower.com withpower.com/trial/blood-donation-for-non-alcoholic-fatty-liver-disease-208ee

Blood Donation for Non-alcoholic Fatty Liver Disease This is a treatment study to determine if reducing the body's iron stores by blood donation will improve diabetes control and other problems associated with ...