Status:
COMPLETED
Myocardial Function and Vitamin D Supplementation in Diabetes.
Lead Sponsor:
University of Avignon
Conditions:
Diabetes Complications
Vitamin D Deficiency
Eligibility:
All Genders
40-65 years
Phase:
NA
Brief Summary
Vitamin D deficiency is recognized as a cardiovascular risk factor. Diabetic patients are of major risk for cardiovascular diseases and typically present with Vitamin D deficiencies. Myocardial functi...
Detailed Description
Rationale: Vitamin D exerts a principal role in homeostasis of calcium and phosphorus. However, recent studies indicated also its important function in cell differentiation, proliferation and growth ...
Eligibility Criteria
Inclusion
- • Male and female 40-65 years old, asymptomatic and free from epicardial coronary artery disease.
Exclusion
- body mass index \> 35 kg / m2, defining severe obesity,
- Under insulin therapy (for Type II only)
- Poorly controlled hypertension (\> 140/95)
- LV ejection fraction (LVEF) \< 55%
- Peripheral vascular disease (\> stage II of Leriche)
- Heart disease or known coronary artery disease,
- Known and poorly compensated thyroid dysfunction,
- Nocturnal apnea syndrome,
- Inability to give written informed consent,
- Chronic diseases,
- moderate to severe left ventricular hypertrophy :\> 109 g / m2 in women and\> 132 g / m2 in men and parietal thickness \> 13mm.
- poor glycemic control (HbA1c \> 9%)
- poor echogenicity
- severe autonomic or peripheral neuropathy,
- Severe diabetic retinopathy,
- Advanced Diabetic nephropathy (defined by documented proteinuria and/or renal failure).
Key Trial Info
Start Date :
February 4 2018
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 19 2023
Estimated Enrollment :
100 Patients enrolled
Trial Details
Trial ID
NCT03437421
Start Date
February 4 2018
End Date
November 19 2023
Last Update
November 29 2023
Active Locations (1)
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1
Hospital Henri Duffaut
Avignon, PACA, France, 84000