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Blood Donation for Non-alcoholic Fatty Liver Disease
N/A
Waitlist Available
Led By Donald A McClain, MD, PhD
Research Sponsored by Wake Forest University Health Sciences
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up month 6, month 12
Summary
This trial will test if giving blood regularly can help people with diabetes better manage their condition and improve related issues like fatty liver disease.
Who is the study for?
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.
What is being tested?
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.
What are the potential side effects?
Potential side effects may include those commonly associated with donating blood such as dizziness, fainting due to low blood pressure after donation (orthostatic hypotension), fatigue, bruising at the needle site, and mild anemia.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ month 6, month 12
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~month 6, month 12
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in ALT
Change in FSIGTT DI (Frequently sampled intravenous glucose tolerance test)
Change in HgbA1C
Secondary study objectives
Change in Blood Pressure
Change in HOMA-IR (Homeostatic Model Assessment-Insulin Resistance)
Change in Weight
+5 moreTrial Design
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
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Who is running the clinical trial?
Wake Forest University Health SciencesLead Sponsor
1,394 Previous Clinical Trials
2,459,968 Total Patients Enrolled
University of North Carolina, Chapel HillOTHER
1,555 Previous Clinical Trials
4,298,365 Total Patients Enrolled
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)NIH
2,446 Previous Clinical Trials
4,331,764 Total Patients Enrolled
1 Trials studying Fatty Liver Disease
144 Patients Enrolled for Fatty Liver Disease
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Eligibility Criteria:
This trial includes the following eligibility 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.Your HgbA1C levels are between 5.7% and 6.4% if you have prediabetes, and between 7% and 8.5% if you have diabetes.You drink more than 4 alcoholic drinks in a day or 14 drinks in a week (for men).I am between 40 and 75 years old.Your C-reactive protein levels are higher than 11.0.Your blood ferritin levels are high, indicating too much iron in your body.My HgA1C level is between 6.5 and 6.9, and I am not on medication.My kidney function is reduced.I have experienced recent blood loss.I have an active cancer diagnosis, not including non-melanoma skin cancers.I have been tested for specific liver infections and am clear, except possibly for HCV which requires further testing.Your C-reactive protein levels are higher than normal, which could indicate ongoing inflammation.I have a history of sudden blood pressure drops when standing up.Your hemoglobin levels are close to the lower limit of normal. For women, this means less than 12.5 g/dL, and for men, less than 13.5 g/dL.You have been diagnosed with anemia.I was diagnosed with prediabetes or diabetes over 3 months ago.Your blood test shows high levels of ALT, or a liver stiffness test indicates potential liver problems.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment Group
- Group 2: Control Group
Awards:
This trial has 0 awards, including:Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
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