Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 11:45 PM
Ignite Modification Date:
2025-12-24 @ 11:45 PM
NCT ID:
NCT01585051
Eligibility Criteria:
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)
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT01585051
Study Brief:
Protocol Section:
NCT01585051