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Blood Donation for Non-alcoholic Fatty Liver Disease
Study 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.
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Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Trial Design
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Who is running the clinical trial?
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- 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.
- Group 1: Treatment Group
- Group 2: Control Group
- 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.
Frequently Asked Questions
Are new participants being sought to join this trial?
"Absolutely. According to clinicaltrials.gov, this investigation is actively seeking participants who were initially invited through an announcement published on the 1st of May 2019 and most recently updated on September 26th 2022. The project requires 240 volunteers from 2 distinct locations across the country."
Who meets the eligibility criteria for participating in this research?
"This medical trial is looking to enrol 240 patients aged between 40 and 75 who present with nonalcoholic fatty liver. In order to participate, individuals must meet the following criteria: have a prediabetes or diabetes diagnosis of at least 3 months old; HgbA1C value in the 5.7-6.4% range for those with pre-diabetes, 7-8.5% for those diagnosed with diabetes (upper limit chosen due to glycemic interventions); undiagnosed on no medications but an HgA1C of 6.5-6.9%; C-reactive protein levels up to 11"
Are applicants below the age of sixty accepted for this research?
"The minimum age for enrollment in this clinical trial is 40, and the cut-off for maximum eligibility is 75 years of age."
What aims is this trial attempting to accomplish?
"This clinical trial will measure the change in FSIGTT DI (Frequently sampled intravenous glucose tolerance test) at its baseline and Month 12. Additional objectives of this study include tracking changes in fasting glucose as recorded by an Abbott Freestyle Libre Pro system, counting how many participants discontinue oral antihyperglycemic agents, and assessing the number of individuals that transition from pre-diabetes to normal gluclose tolerance according to HbA1C criteria."
How many participants is the research team recruiting for this experiment?
"Affirmative. As observed on clinicaltrials.gov, the trial that began recruiting patients on May 1st 2019 is still actively looking for participants to enroll in this study; 240 people need to be recruited from 2 medical facilities."
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