68 Participants Needed

Blood Donation for Non-alcoholic Fatty Liver Disease

Recruiting at 1 trial location
DA
AB
Overseen ByAudrey Bell-Farrow, MBA, MHA
Age: 18+
Sex: Any
Trial Phase: Academic
Sponsor: Wake Forest University Health Sciences
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Approved in 3 JurisdictionsThis treatment is already approved in other countries

Trial Summary

What is the purpose of this trial?

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 diabetes such as fatty liver disease.

Research Team

DA

Donald A McClain, MD

Principal Investigator

Wake Forest University Health Sciences

Eligibility Criteria

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.
See 4 more

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.
See 9 more

Timeline

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

Treatment Details

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.
Participant Groups
2Treatment groups
Active Control
Placebo Group
Group I: Treatment GroupActive Control1 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 GroupPlacebo Group1 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:

πŸ‡ΊπŸ‡Έ
Approved in United States as Blood Donation for:
  • Iron overload
  • Polycythemia vera
  • Porphyria cutanea tarda
πŸ‡ͺπŸ‡Ί
Approved in European Union as Blood Donation for:
  • Iron overload
  • Polycythemia vera
  • Porphyria cutanea tarda
πŸ‡¨πŸ‡¦
Approved in Canada as Blood Donation for:
  • Iron overload
  • Polycythemia vera
  • Porphyria cutanea tarda

Find a Clinic Near You

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+
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