Effects of Vitamin D on Beta Cell Function and Insulin Sensitivity in Pre-diabetes and Diabetes Mellitus Type 2 (EVIDENS)

Inclusion Criteria:

• Meeting criteria for IFG, IGT, IFG+IGT or diabetes mellitus at OGTT.
• BMI ≤ 32 kg/m2.
• HbA1c ≤ 7.0 % (MonoS) or ≤ 63 mmol/mol (IFCC).
• Fasting plasma glucose < 9 mmol/l
• S-25-OH-vitamin D3 < 75 nmol/l.

Exclusion Criteria:

• Treatment with any vitamin D preparation.
• Regular sun-bathing in solarium.
• Hypercalcemia at screening, defined as free s-calcium > 1.35 mmol/l.
• Hyperphosphatemia at screening, defined as s-phosphate > 1.5 mmol/l.
• Sarcoidosis or other granulomatous disease.
• Treatment with phenytoin, barbiturates, rifampicin, isoniazid, cardiac glycosides, orlistat or colestyramin.
• Impaired hepatic function.
• Impaired renal function

• Cardiac disease defined as:

  • Unstable angina pectoris
  • Myocardial infarction within the last 6 months
  • Congestive heart failure NYHA class III and IV
• Cerebral stroke within the last 6 months.
• Anti-diabetic medication of any kind.
• Females of childbearing potential who are pregnant, breast-feeding or intend to become pregnant or are not using adequate contraceptive methods.