Clinical trial NCT01183442: Vitamin D Supplementation in CAD and Postchallenge Hyperglycemia
Official title: Effects of Vitamin D Supplementation in Coronary Artery Disease Patients With Postchallenge Hyperglycemia and Vitamin D Deficiency on Endothelial Function and Insulin Sensitivity
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE3
Conditions: Coronary Artery Disease
Postprandial Hyperglycemia
Vitamin D Deficiency
Keywords: endothelial function
insulin sensitivity
Lead sponsor: Medical University of Graz
Sponsor class: OTHER
First posted: 2010-08-17
Enrollment: 22
Sex: ALL
Minimum age (years): 40
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: The main aim of the investigation is to clarify, whether vitamin D supplementation in coronary artery disease patients with vitamin D deficiency and postchallenge hyperglycemia has an impact on endothelial dysfunction and parameters of insulin sensitivity and beta-cell function.

Detailed description: An improvement of endothelial dysfunction as a cardiovascular surrogate parameter could be translated in a reduced risk for future cardiovascular events, which is of major interest, since patients with postchallenge hyperglycemia face a significantly higher cardiovascular risk than patients with normal glucose tolerance. Furthermore an improvement in insulin sensitivity and/or beta-cell function would identify vitamin D as an important strategy for the prevention of type 2 diabetes. In consideration of the rapidly increasing prevalence of diabetes and the failure of current prevention strategies this could be an important, safe and cheap way to support ongoing lifestyle modifying programs. Our study of course investigates surrogate cardiovascular and insulin sensitivity parameters. Assuming a beneficial effect of vitamin D in our study, this concept would have to be proven in further large outcome as well as diabetes prevention trials.

Eligibility criteria: Inclusion Criteria:

* Age 40-75
* Postchallenge hyperglycemia (2h-whole blood glucose value in oral glucose tolerance test above 119 mg/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 antihypertensive therapy in the last 3 month

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
* Hypercalcaemia
* Major psychiatric disorders
* Ongoing treatment with spironolactone, canrenoate, eplerenone, amiloride, triamterene and aliskiren.
* Treatment with antipsychotic drugs
* Regular significant antioxidants, vitamins or protein supplementation
* Immunosuppressive therapy
* Glucocorticoid therapy
* Ongoing chemotherapy
* Pregnancy
* Any other disease with an estimated life expectancy below 1 year.

Primary outcomes:
measure: endothelial dysfunction
timeFrame: 1 year
Secondary outcomes:
measure: insulin resistance and beta-cell function
timeFrame: 1 year
Other outcomes:
Locations:
city: Graz
country: Austria
facility: Dept. of Internal Medicine, Medical University of Graz
Study officials:
affiliation: Medical University of Graz, Graz, Austria
name: Thomas R. Pieber, MD
role: PRINCIPAL_INVESTIGATOR
References: