- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03437421
Myocardial Function and Vitamin D Supplementation in Diabetes. (VitaDD)
Effect of Vitamin D Supplementation on Myocardial Regional Function by Dobutamine Stress Echocardiography in Diabetic Patients.
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.
Study Overview
Status
Conditions
Intervention / Treatment
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 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).
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
Paca
-
Avignon, Paca, France, 84000
- Hospital Henri Duffaut
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Description
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 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).
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Supportive Care
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: Single
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Type II diabetic patients
3 month Vitamin D3 (cholecalciferol) supplementation in patients with vitamin D deficiency, based on 25-OH-D3 dosage.
|
|
Experimental: Type I diabetic patients
3 month Vitamin D3 (cholecalciferol) supplementation in patients with vitamin D deficiency, based on 25-OH-D3 dosage.
|
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Change in longitudinal strain
Time Frame: Before and after 3 month of Vitamin D supplementation
|
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
|
Collaborators and Investigators
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Endocrine System Diseases
- Diabetes Mellitus
- Nutrition Disorders
- Avitaminosis
- Deficiency Diseases
- Malnutrition
- Vitamin D Deficiency
- Diabetes Complications
- Physiological Effects of Drugs
- Micronutrients
- Vitamins
- Bone Density Conservation Agents
- Calcium-Regulating Hormones and Agents
- Vitamin D
- Cholecalciferol
Other Study ID Numbers
- UAPV-022018-SFC
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Diabetes Complications
-
Hennepin Healthcare Research InstituteCompletedHyperglycemia | Diabetes Mellitus, Type 2 | Diabetes Mellitus | Complications of Diabetes Mellitus | Diabetes-Related ComplicationsUnited States
-
Royal Prince Alfred Hospital, Sydney, AustraliaMerck Sharp & Dohme LLCCompletedDiabetes Related Complications
-
University of Trás-os-Montes and Alto DouroCompletedType 2 Diabetes Mellitus | Diabetes-Related ComplicationsPortugal
-
Seoul St. Mary's HospitalUnknownComplications of Diabetes MellitusKorea, Republic of
-
University of AvignonCompletedDiabetes-related ComplicationsFrance
-
Albert Einstein College of MedicineJuvenile Diabetes Research Foundation; National Institutes of Health (NIH)Completed
-
Naestved HospitalUnknown
-
University of Campinas, BrazilConselho Nacional de Desenvolvimento Científico e Tecnológico; ANS PharmaUnknownDiabetes Mellitus, Type 2 | Insulin Resistance | Diabetes-Related ComplicationsBrazil
-
University of AarhusUnknownDiabetes Mellitus, Type 2 | Diabetic Neuropathies | Autonomic Neuropathy | Diabetic Complications Neurological | Polyneuropathy DiabetesDenmark
-
Rambam Health Care CampusUnknown
Clinical Trials on Vitamin D3 (cholecalciferol)
-
Medical University of South CarolinaThrasher Research FundCompletedVitamin D Deficiency | PregnancyUnited States
-
Medical University of South CarolinaEunice Kennedy Shriver National Institute of Child Health and Human Development... and other collaboratorsCompleted
-
Mahidol UniversityUnknownCritical Illness | Vitamin D Deficiency | SarcopeniaThailand
-
Brigham and Women's HospitalNational Heart, Lung, and Blood Institute (NHLBI)Active, not recruiting
-
Medical University of South CarolinaEunice Kennedy Shriver National Institute of Child Health and Human Development...Completed
-
University of California, San FranciscoCompletedUlcerative Colitis (UC) | Crohn's Disease (CD)United States
-
National Institute of Allergy and Infectious Diseases...Autoimmunity Centers of ExcellenceTerminatedSystemic Lupus ErythematosusUnited States
-
Sanjay Gandhi Postgraduate Institute of Medical...CompletedPancreatitis, ChronicIndia
-
Atlanta VA Medical CenterCompletedVitamin D Deficiency | Chronic Kidney DiseaseUnited States
-
University of PittsburghNational Heart, Lung, and Blood Institute (NHLBI)CompletedCystic Fibrosis | Allergic Bronchopulmonary AspergillosisUnited States