A Double Blind Randomised Placebo-controlled Trial to Assess the Role of Iron Repletion in Glucose Homeostasis.

Exclusion Criteria

• •Age \<18 years.
• •Menopause (defined as an amenorrhea of at least 12 months).
• •Body mass index \<18.5 kg/m2 or \>30 kg/m2.
• •Diabetes, defined as subjects with HbA1c ≥ 6.5 % and/or with fasting blood glucose levels ≥ 7 mmol/l and/or with a history of diabetes and/or by the use of anti-diabetic drugs.
• •Hb level \<117 g/L or known haemoglobinopathy or haemochromatosis.
• •Blood transfusion within the last 12 weeks.
• •Intake of iron preparations 4 weeks prior to screening.
• •Known hypersensitivity to FCM or to any other iron preparation.
• •Suspicion of major depressive disorder based on Patient Health Questionnaire.
• •Known chronic inflammatory disease, including human immunodeficiency virus, hepatitis B or hepatitis C virus infection.
• •Active malignancy.
• •Decreased renal function (estimated glomerular filtration rate using the CKD-EPI equation\<60 ml/min/1.73m2).
• •Liver dysfunction (aspartate aminotransferase and alanine aminotransferase \> 3-fold upper limit).
• •Angina (Class IV).
• •Asthma.
• •Documented sleep apnoea.
• •Important recent weight loss (\>10% within the past month).
• •Thyroid dysfunction (thyroid stimulating hormone \>4 µU/mL).
• •Reported weekly alcohol consumption \> 14 standard drinks.
• •Drug abuse (any drug consumption reported in the past 12 months).