Type 2 diabetes mellitus Insulin resistance Vitamin D deficiency
Conditions
Interventions
Group1: Cholecalciferol 50.000IU once a month during 6 months
Group 2: Placebo 50.000IU once a month during 6 months.
Sponsors
S.Simsek
Medisch Centrum Alkmaar
Eligibility
Inclusion criteria
Inclusion criteria: 1. Written informed consent; 2. Patients with T2DM treated with lifestyle advises whether or not in combination with metformin; 3. Adults (≥ 18 years); 4. HbA1c values between 7.0 - 8.5% for the last 3 months.
Exclusion criteria
Exclusion criteria: 1. Impaired renal function: creatinine * 150 *mol/l or an estimated creatinin clearance 150 nmol/l; 6. Hypercalcemia of any reason; 7. Urolithiasis; 8. Granulomatous diseases influencing vitamin D levels; 9. Diabetes mellitus other than type 2; 10. Recent or current use of insulin or incretin mimetics; 11. Using other oral antidiabetics than metformin; 12. Pregnancy and/or lactation; 13. Substance abuse, other than nicotine; 14. Participation in any other trials, involving investigational products within 30 days prior to trial entry; 15. Any condition that the Investigator and/or Coordinating Investigator feels would interfere with trial participation or evaluation of results.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| HbA 1c values. | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. The effect of vitamin D supplementation on serum 25OHD, insulin sensitivity, bloodpressure, thyroid function, lipid profile and BMI in patients with type 2 diabets melltius; 2. Adverse effects. | — |
Contacts
Public ContactY.H.M. Poel
Medisch Centrum Alkmaar Wilhelminalaan 12
Outcome results
None listed