Blood Donation for Non-alcoholic Fatty Liver Disease
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
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
Exclusion Criteria
Timeline
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants undergo phlebotomy to reduce iron levels, with glucose control monitored through standard blood tests and continuous glucose monitoring
Follow-up
Participants are monitored for safety and effectiveness after treatment
Optional Substudies
Participants may opt into substudies focusing on liver complications and glucose tolerance mechanisms
Treatment Details
Interventions
- Blood Donation
- Sham Blood Donation
Blood Donation is already approved in United States, European Union, Canada for the following indications:
- Iron overload
- Polycythemia vera
- Porphyria cutanea tarda
- Iron overload
- Polycythemia vera
- Porphyria cutanea tarda
- 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
University of North Carolina, Chapel Hill
Collaborator
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Collaborator