Myocardial Function and Vitamin D Supplementation in Diabetes.

NCT03437421 | Completed

• 1 other identifier: UAPV-022018-SFC
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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 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.

Conditions

Diabetes Complications; Vitamin D Deficiency; Vitamin D Supplementation; Myocardial Dysfunction

Keywords

myocardial function; vitamin D; stress echocardiography; diabetes

Outcome Measures

Primary Outcomes (1)

• Change in longitudinal strain

  Index of myocardial function measured using deformation imaging technique by echocardiography, at rest and under dobutamine stress.

  Before and after 3 month of Vitamin D supplementation

Study Arms (2)

Type II diabetic patients

EXPERIMENTAL

3 month Vitamin D3 (cholecalciferol) supplementation in patients with vitamin D deficiency, based on 25-OH-D3 dosage.

Dietary Supplement: Vitamin D3 (cholecalciferol)

Type I diabetic patients

EXPERIMENTAL

3 month Vitamin D3 (cholecalciferol) supplementation in patients with vitamin D deficiency, based on 25-OH-D3 dosage.

Dietary Supplement: Vitamin D3 (cholecalciferol)

Interventions

Vitamin D3 (cholecalciferol) DIETARY_SUPPLEMENT

* 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 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™) followed for the last month by one daily dose (5 drops orally =1 000 UI/day, DÉDROGYL™ ). * 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™) followed for the last month by one daily dose (5 drops orally =1 000 UI/day, DÉDROGYL™).

Type I diabetic patients; Type II diabetic patients

Eligibility Criteria

• Age: 40 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify if:

• 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,

Sponsors & Collaborators

• University of Avignon: lead

Study Sites (1)

Hospital Henri Duffaut

Avignon, PACA, 84000, France

Location

Related Publications (1)

• Obert P, Nottin S, Philouze C, Aboukhoudir F. Major impact of vitamin D3 deficiency and supplementation on left ventricular torsional mechanics during dobutamine stress in uncomplicated type 2 diabetes. Nutr Metab Cardiovasc Dis. 2023 Nov;33(11):2269-2279. doi: 10.1016/j.numecd.2023.06.017. Epub 2023 Jun 24.

  PMID: 37543521 DERIVED

MeSH Terms

Conditions

Diabetes Complications; Vitamin D Deficiency; Diabetes Mellitus

Interventions

Cholecalciferol

Condition Hierarchy (Ancestors)

Endocrine System Diseases; Avitaminosis; Deficiency Diseases; Malnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Glucose Metabolism Disorders; Metabolic Diseases

Intervention Hierarchy (Ancestors)

Cholestenes; Cholestanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; Sterols; Vitamin D; Secosteroids; Membrane Lipids; Lipids

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Single-masked study. Clinicians and researchers in charge of main outcomes (eg cardiac remodelling and global function, regional myocardial function) measurements will not be aware of group allocation (eg vitamin D deficient and non-deficient sub-groups) and time study (eg baseline or post vitamin D supplementation).
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Type I and II diabetic patients will be investigated. Within each diabetic population, vitamin D deficient and non-deficient individuals will be compared at baseline. Then, within each diabetic population, those with vitamin D deficiency at baseline will be compared before and after a 3 month vitamin D supplementation.

Study Record Dates

• First Submitted: February 6, 2018
• First Posted: February 19, 2018
• Study Start: February 4, 2018
• Primary Completion: September 1, 2023
• Study Completion: November 19, 2023
• Last Updated: November 29, 2023

Record last verified: 2023-11

Locations

FR (1)