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

Karolinska Institute

Status and phase

Completed

Phase 4

Conditions

Vitamin D Deficiency

Diabetes Mellitus, Type 2

Glucose Intolerance

Treatments

Drug: Placebo

Drug: Vitamin D3

Study type

Interventional

Funder types

Other

Identifiers

NCT01497132

2010-024487-18 (EudraCT Number)

DvitamininDM2_v1_110815

Details and patient eligibility

About

The purpose of this study is to evaluate if treatment with vitamin D increase beta cell function and insulin sensitivity in subjects with pre-diabetes or newly diagnosed diabetes mellitus type 2.

Enrollment

44 patients

Sex

All

Ages

45 to 75 years old

Volunteers

No Healthy Volunteers

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.