Myocardial Function and Vitamin D Supplementation in Diabetes. (VitaDD)

  • STATUS
    Recruiting
  • End date
    Dec 19, 2023
  • participants needed
    100
  • sponsor
    University of Avignon
Updated on 25 March 2022
diabetes
cholecalciferol
vitamin d
vitamin d supplementation
malnutrition
vitamins

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 function is altered in both type I and II diabetic patients but no data is today available on the effect of Vitamin D supplementation.

The aim of the study will be to investigate myocardial function (by deformation imaging techniques) at rest and during low-dose dobutamine stress echocardiography in both type I and II diabetic patients. Within each diabetic population, myocardial function will be compared at baseline between the vitamin D deficient and non-deficient individuals. Furthermore, the investigators will study the effect of a 3 month supplementation in those with deficiencies.

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 as well as regulation of the immune system.

Vitamin Deficiency is today recognized as a risk factor for cardiovascular disease (CVD). Diabetic patients are of major risk for CVD. They typically present with Vitamin D deficiencies. Experimental studies have established as a result of Vitamin D deficiency alterations in intrinsic cardiac contractile and relaxation properties, hypertrophy and fibrosis. Regional myocardial function is altered in both type I and II diabetic patients. In type II diabetic individuals, myocardial dysfunction is furthermore exacerbated in those with Vitamin D deficiency compared to those with normal levels. In patients free from CV risk and deficient in Vitamin D, regional myocardial function improved after Vitamin D supplementation. To the best of our knowledge, no scientific study is today available on the effect of Vitamin D supplementation on regional myocardial function in diabetic patients deficient in vitamin D.

Objectives and Methodology:

  • To compare regional myocardial linear deformation and torsion, at rest and in response to a DB stress in diabetic patients deficient and non-deficient in Vitamin D.
  • To evaluate the impact of vitamin D supplementation in those with vitamin D deficiency.

All the diabetic patients will benefit from a clinical (medical history, drug therapy, ECG, blood pressure, ...), anthropometric (abdominal obesity indices) and biological (carbohydrate and lipid balance, markers of inflammation and heart failure, vitamin D glucose and insulin status) evaluation. In addition, conventional echocardiography (remodelling and global diastolic and systolic function) complemented by a functional analysis by tissue Doppler imaging will be performed. Furthermore, 2D cine loops will be recorded in the apical 4, 3 and 2- chamber views for the assessment of regional myocardial longitudinal deformations as well as in the parasternal short axis (base, mid and apex) for the evaluation of circumferential deformations and basal and apical rotation and torsion, at rest and under low dose dobutamine (110 and 120 bpm).

Vitamin D supplementation:

Patients with vitamin D deficiency will be investigated before and after a 3 month cholecalciferol supplementation.

For this purpose 25-OH-D3 with be evaluated at baseline.

  • Patients with 29≤ 25-OH-D3 ≥20 ng/mL will receive 200 000 UI orally the first month (100 000 UI at T0 + 100 000 UI at T0+15 days, UVEDOSE™ Laboratoires Crinex, Montrouge, France) followed thereafter for the last 2 months by one daily dose (5 drops orally = 1 000 UI/day, DÉDROGYL™ , DB Pharma, La Varenne-Saint-Hilaire, France).
  • Patients with : 19≤ 25-OH-D3 ≥10 ng/mL will receive orally 300 000 UI (100 000 UI at T0 + 100 000 UI at T0+23days + 100 000 UI at T0+45days; UVEDOSE™ Laboratoires Crinex, Montrouge, France) followed thereafter for the last month by one daily dose (5 drops orally =1 000 UI/day, DÉDROGYL™ , DB Pharma, La Varenne-Saint-Hilaire, France).
  • Patients with : 25-OH-D3 <10 ng/mL will receive orally 400 000 UI (100 000 UI at T0 + 100 000 UI at T0+15days + 100 000 UI at T0+30 days + 100 000 UI at T0+45days, UVEDOSE™ Laboratoires Crinex, Montrouge, France) followed thereafter for the last month by one daily dose (5 drops orally =1 000 UI/day, DÉDROGYL™ , DB Pharma, La Varenne-Saint-Hilaire, France).

Details
Condition Diabetes Complications, Vitamin D Deficiency, Vitamin D Supplementation, Myocardial Dysfunction
Treatment Vitamin D3 (cholecalciferol)
Clinical Study IdentifierNCT03437421
SponsorUniversity of Avignon
Last Modified on25 March 2022

Eligibility

Yes No Not Sure

Inclusion Criteria

• Male and female 40-65 years old, asymptomatic and free from epicardial coronary artery
disease

Exclusion Criteria

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
poor glycemic control (HbA1c > 9%)
in men and parietal thickness > 13mm
poor echogenicity
severe autonomic or peripheral neuropathy
Severe diabetic retinopathy
Advanced Diabetic nephropathy (defined by documented proteinuria and/or renal
failure)
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