NCT03696797Completed
Iron Reduction for the Treatment of Diabetes and Nonalcoholic Fatty Liver Disease
Iron Reduction by Phlebotomy for the Treatment of Diabetes and Nonalcoholic Fatty Liver Disease
Source: ClinicalTrials.gov · Last updated 9 Jun 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Study type
- Interventional
- Enrollment
- 132 (actual)
- First submitted
- 3 Oct 2018
- Start date
- 3 May 2019
- Primary completion date
- 3 Jan 2025
- Lead sponsor
- Wake Forest University Health Sciences
- Diseases
- Fatty liver disease (MASLD/MASH)
- NCT number
- NCT03696797
What you commit to
- Study type: Interventional
- Participants enrolled: 132
- From 3 May 2019 to the primary completion date, 3 Jan 2025
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Bleeding diatheses (coagulation abnormalities or treatment with anticoagulants)
Other illness
- Serious chronic infections or chronic inflammatory conditions that could elevate ferritin as an "acute phase reactant
- Active cancer diagnosis (excluding skin cell cancers other than melanoma)
- History of orthostatic hypotension
- Aim 2 - individuals meeting the additional inclusion criteria for aim 2 will be tested for anti-HAV IgM, HBs Ag, anti-HBc. IgM, anti HCV IgM and IgG. Subjects who prove positive for any of these viral serologies, except for HCV IgG will be excluded. The latter will be tested for HCV RNA by PRC, and if negative they will be eligible for enrollment
Lab values
- Hemoglobin levels within 0.5 g/dL of the lower limit of normal (\<12.5 g/dL for women; 13.5 g/dL for men)
- Renal insufficiency (eGFR\<60 ml/min)
Age
- Pregnancy or premenopausal women of childbearing age, unless unable to become pregnant because of oral contraceptive use or surgical loss of ovaries or uterus
Other
- Documented anemia
- Recent blood loss
- C-reactive protein greater than the upper limit of normal to further validate the lack of significant chronic inflammation
- Heavy alcohol use (NIH criteria for men, greater than 4 drinks on any day or 14/week)
Who the study is looking for
- Ages 40-75
- At least 3 months since diagnosis of prediabetes or diabetes
- HgbA1C value within three months or at screening of 5.7-6.4% for those with prediabetes and 7- 8.5% for those with diabetes (the upper limit of the latter to reduce the likelihood of major changes in glycemic intervention during the trial period, and the lower limit to allow some room for improvement)
- Undiagnosed on no medication HgA1C 6.5-6.9
- C-reactive protein levels up to 11.0
- Aim 2-serum ALT\> 1.5 times the upper limit of normal, or; liver stiffness of \> 12.5 kPa by Fibroscan transient elastography
- Serum ferritin levels within 1 year or at the time of screening in the upper half of the normal range (\>50 ng/mL for women; \>100ng/mL for men)
Age in the registry: 40 years to 75 years · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| University of North Carolina at Chapel Hill (UNC) Coordinator of this site? Confirm its status | Chapel Hill | United States | Unknown status |
| Wake Forest University Health Sciences Coordinator of this site? Confirm its status | Winston-Salem | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.