Iron Reduction for the Treatment of Diabetes and Nonalcoholic Fatty Liver Disease
Completed · Not applicable · Has a placebo group
Conditions studied: Iron, Diabetes, Nonalcoholic Fatty Liver
In brief
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.
Key facts
- Study ID
- NCT03696797
- Run by
- Wake Forest University Health Sciences
- People needed
- 132
- Starts
- 2019-05-03
- Expected to finish
- 2025-01-03
- Last updated by the study team
- 2026-06-09
Who can join
Age: 40 and older, up to 75. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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)
You may not qualify if…
- Documented anemia
- 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)
- Recent blood loss
- Bleeding diatheses (coagulation abnormalities or treatment with anticoagulants)
- Serious chronic infections or chronic inflammatory conditions that could elevate ferritin as an "acute phase reactant
- C-reactive protein greater than the upper limit of normal to further validate the lack of significant chronic inflammation
- Active cancer diagnosis (excluding skin cell cancers other than melanoma)
- Renal insufficiency (eGFR<60 ml/min)
- History of orthostatic hypotension
- Heavy alcohol use (NIH criteria for men, greater than 4 drinks on any day or 14/week)
- Pregnancy or premenopausal women of childbearing age, unless unable to become pregnant because of oral contraceptive use or surgical loss of ovaries or uterus
- 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
Where it is running
- University of North Carolina at Chapel Hill (UNC) — Chapel Hill, North Carolina, United States
- Wake Forest University Health Sciences — Winston-Salem, North Carolina, United States
Full record on ClinicalTrials.gov
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