Iron Reduction for the Treatment of Diabetes and Nonalcoholic Fatty Liver Disease

Korábbi kezelés

• Bleeding diatheses (coagulation abnormalities or treatment with anticoagulants)

Más betegség

• 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

Laborértékek

• 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)

Életkor

• Pregnancy or premenopausal women of childbearing age, unless unable to become pregnant because of oral contraceptive use or surgical loss of ovaries or uterus

Egyéb

• 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)

• 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)