Effects of vitamin D supplementation in coronary artery disease patients with postchallenge hyperglycemia and vitamin D deficiency on endothelial function and insulin sensivitivity

Phase 1

Conditions: subjects with coronary artery disease, postchallenge hyperglycemia and low levels of 24-OH-vitamin D

Registration Number: EUCTR2009-015776-95-AT

Lead Sponsor: niversitätsklinik für Innere Medizin, Klinische Abteilung für Endokrinologie und Nuklearmedizin

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: ot Recruiting

Sex: All

Target Recruitment: Not specified

Inclusion Criteria

- Age 40-75
- Postchallenge hyperglycemia (2h value in oral glucose tolerance test above 139mg/dl, normal fasting glucose)
- Angiographically verified coronary artery disease (>50% stenosis)
- Serum 25-OH- vitamin D < 20 ng/ml in winter/spring/autumn and <25 ng/ml during june-september
- Stable antihyptertensive therapy in the last 3 month

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

•Acute coronary syndrome or cerebrovascular event within the previous 1 month
•BMI > 40 kg/m²
•Serum creatinine >2.5 times the upper limit of normal
•GOT or GPT > 3 times the upper limit of normal
•Heart failure > NYHA class II
•Uncontrolled hypertension (>160/100 mmHg)
•New onset of statins, ACE-inhibitors or ARBs within the previous 4 weeks
•History of urolithiasis
•Hypercalaemia
•Major psychiatric disorders
•Ongoing treatment with spironolactone, canrenoate, eplerenone, amiloride, triamteren and aliskiren.
•immunosuppressive therapy
•glucocorticoid therapy
•ongoing chemotherapy
•pregnancy
•any other disease with an estimated life expectancy below 1 year.

Study & Design

Study Type: Interventional clinical trial of medicinal product

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Main Objective: Changes in endothelial dysfunction (peripheral artery tone (PAT) and biochemical) by vitamin D supplementation.;Primary end point(s): Changes in endothelial dysfunction (peripheral artery tone (PAT) and biochemical) ;Secondary Objective: Changes in indices for insulin resistance and beta-cell function. <br>Changes in blood pressure.<br>Changes in markers of chronic inflammation<br>Changes in levels of renin and aldosterone<br>Changes in levels of NT-proBNP <br>

Secondary Outcome Measures