Diabetes Mellitus Type 2
Conditions
Keywords
vitamin D, blood pressure, typ 2 diabetes mellitus, blood glucose, HbA1c
Brief summary
The effect of administration of vitamin D is tested on the long-term control of blood sugar (as measured by HbA1-c levels in blood) and mean blood pressure (as measured by 24 hour blood pressure profiles)in patients with stable type 2 diabetes mellitus
Interventions
DRUG25(OH) vitamin D
300 000 U intramuscularly, one dosage, in subjects with 25 (OH) vit D levels below 80 nmol/L, another dosage of 150 000 U after 3 months if 25(OH)vit D levels continue to be below 80 nmol/L.
DRUG0.9 % NaCl
1 ml of 0.9 % of NaCl at the beginning and 0.5 ml of 0.9 % NaCl after three months
Sponsors
Kantonsspital Baselland Bruderholz
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
QUADRUPLE (Subject, Caregiver, Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Men and women, ages ≥18 years * Official diagnostic criteria for type 2 diabetes fulfilled in patients on any type of oral or parenteral glucose-lowering treatment * Independent living at home * On stable regimen of BP meds (if any) with BP well controlled and/or K supplement (if any) for 2 months and which is deemed unlikely to change during the study * Stable glucose control for 2 months by any approved method including insulin
Exclusion criteria
* Patients with type 1 diabetes (or insulin-requiring diabetes of unclear type) * Patients on hemodialysis, with hyperparathyroidism or active cancer disease * Patients with known metabolic bone disease * Laboratory evidence of kidney (eGFR \< 60 ml/min) or liver disease * Dietary calcium intake exceeding 1500mg/d (as estimated by dietary history) * 25(OH) vitamin D levels at baseline \> 70 nmol/L * Calciuria (\> 8 mmol/24 hours as measured by 24 hour urine collections) * Hypo- and hypercalcemias and hypo- and hyperphosphatemias of any cause * Medications that affect vitamin D metabolism (e.g. antiepileptic drugs, calcimimetics, 1-34 PTH (Forsteo) vitamin D therapy over and above 400U daily 6 months prior to enrollment and during the study) * Foreseeable need for adaptation of either glucose- or blood pressure lowering during the next 6 months as decided by the family physician or the treating diabetologist - see above * History of binge eating or wt gain or loss exceeding 6 kg in past 18 months * Patients on any type of inhibitors of plasma coagulation (i.e. coumarine, heparins)
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in HBA1-c levels | 3 and 6 months |
| 24 hour mean blood pressure | 3 and 6 months |
Secondary
| Measure | Time frame |
|---|---|
| plasma glucose | 3 and 6 months |
| HOMA | 6 months |
Countries
Switzerland
Outcome results
None listed