Non-insulin demanding type 2 diabetes
Conditions
Interventions
Trade Name: Vigantol ÖL
Pharmaceutical Form: Oral drops, solution
INN or Proposed INN: cholecalciferol
Concentration unit: IU international unit(s)
Concentration type: equal
Concentration number: 2000
Sponsors
Johann Wolfgang Goethe Universität
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: Age > 18 years In female subjects: postmenopausal status or practice of a highly reliable method of contraception Diabetes mellitus type 2, controlled by diet and oral antidiabetic drugs Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range
Exclusion criteria
Exclusion criteria: Active, consuming diseases (cancer, HIV) Renal failure (creatinine > 1,5 mg/dl) Liver diseases (AST, ALT >1.5x ULN)) Psychiatric diseases Hypercalcaemia Nephrolyths (current or in patient’s history) Sarcoidosis (current or in patient’s history) Treatment with vitamin D, biphosphanates, calcium mimetics, insulin, phenytoin, oral corticosteroids, glycosides, benzodiazepine) Pregnancy or missing contraception in childbearing age, lactation
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Main Objective: Evaluation whether a vitamin D substitution reduces the insulin resistance and the function of the lymphocytes in patients with type 2 diabetes who are under treatment with diet and oral antidiabetic drugs;Secondary Objective: None;Primary end point(s): Difference in insulin resistance (measured by fasting blood glucose and HOMA-IR) after 6 months of treatment and 6 months of follow up between Vigantol Oil and Placebo Oil | — |
Countries
Germany
Outcome results
None listed