Vascular and Metabolic Effects of Vitamin D Supplementation Associated With Lifestyle Management in Obese Adolescents
- Conditions
- Obesity
- Interventions
- Other: Normal controlDrug: PlaceboOther: 3 months lifestyle and dietary management
- Registration Number
- NCT02400151
- Lead Sponsor
- Centre Hospitalier Universitaire de Nīmes
- Brief Summary
The main objective of this study is to analyze in a population of obese adolescents, the effect of vitamin D3 supplementation in addition to lifestyle and dietary management on vascular function assessed by the change between M0 and M3 of endothelium-dependent vasorelaxation measured at the brachial artery (Flow-Mediated Dilation).
- Detailed Description
The secondary objectives of this study are:
A. To analyze in obese adolescents, the effect of the addition of vitamin D3 supplementation on metabolic and vascular function.
B. To compare the relationships between food intake, metabolic, inflammatory, oxidative stress and vitamin D status, and vascular dysfunction between obese and normal weight subjects.
C. To evaluate the effects of sun exposure variations on relationships described in Objective B by comparing the observed parameters at baseline and at the end of the three month follow-up period, in non-supplemented obese adolescents and adolescents of normal weight.
D. To identify biomarkers (metabolic signatures) in obese adolescents associated with vitamin D deficiency and vascular function.
E. To evaluate in obese adolescents, the effects of vitamin D supplementation on the metabolome (metabolic signature).
F. To evaluate the effects of lifestyle and dietary management on these biomarkers (in the "control group").
For these targets (A to F), all teenagers will be classified according to three levels of skin pigmentation.
G. Establish a biobank of samples taken at baseline and at 3 months.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 49
- The patient's legal representatives must have given their informed and signed consent
- The patient must be insured or beneficiary of a health insurance plan
- Sexual maturation of at least Tanner stage 2
Inclusion criteria for the patient population
- The subject has a body mass index corresponding to grade 2 obesity according to the curves described by Rolland-Cachera et al (1991)
- Absence of at least 5% of total weight over the last 3 months
Inclusion criteria for the control population
- The subject has a body mass index < 90th percentile
- The patient is participating in another study
- The patient is in an exclusion period determined by a previous study
- The patient is under judicial protection
- The patient's legal representative(s) refuse(s) to sign the consent
- It is impossible to correctly inform the patient or his/her legal representative(s)
- The patient has a contraindication for physical activity (joint, heart or other)
- The subject does at least 3 hours of extracurricular physical activity per week
- The subject has a concomitant illness, a history of first-degree cardiovascular disease, abnormal glucose tolerance (pre-diabetes or diabetes).
- Active smoking
- Known dyslipidemia (particularly hypercholesterolemia).
- The subject regularly takes food and vitamin supplements and refuses to stop taking these during the study (in case of disruption of these supplements, a wash-out stopping period of 3 weeks is required).
- BMI corresponding to a grade 1 obesity according to the Rolland-Cachera et al. (1991) curves.
- Secondary or known genetic obesity.
- Known hypersensitivity to vitamin D.
- Hypercalcemia, hypercalciuria, calcium lithiasis
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- PARALLEL
- Arm && Interventions
Group Intervention Description Non-Obese group Normal control Non-obese patients will be recruited and frequency matched to obese groups according to sex and level of sexual maturation. Intervention: Normal control Obese group, Vitamin D 3 months lifestyle and dietary management Subjects randomized to this group will receive vitamin D supplementation. They are recruited from the St Pierre Institute at Palavas-les-Flots, France. Intervention: 3 months lifestyle and dietary management Intervention: Vitamin D supplementation Obese group, placebo Placebo Subjects randomized to this group will receive a placebo supplement. They are recruited from the St Pierre Institute at Palavas-les-Flots, France. Intervention: 3 months lifestyle and dietary management Intervention: Placebo Obese group, placebo 3 months lifestyle and dietary management Subjects randomized to this group will receive a placebo supplement. They are recruited from the St Pierre Institute at Palavas-les-Flots, France. Intervention: 3 months lifestyle and dietary management Intervention: Placebo Obese group, Vitamin D Vitamin D supplementation Subjects randomized to this group will receive vitamin D supplementation. They are recruited from the St Pierre Institute at Palavas-les-Flots, France. Intervention: 3 months lifestyle and dietary management Intervention: Vitamin D supplementation
- Primary Outcome Measures
Name Time Method Change from baseline in Flow Mediated Dilation (%) at the brachial artery 3 months
- Secondary Outcome Measures
Name Time Method Change from baseline in brachial compliance (mm^2mmHg^-1) 3 months Change from baseline in Isoprostanes (ng*L^-1) 3 months Change from baseline in nitrite-nitrate (µmol*L^-1) 3 months Change from baseline in PAI-1 (µmol*L^-1) 3 months Metabolomic profile 3 months Change from baseline in Nitrate Mediated Dilation (%) at the brachial artery 3 months Change from baseline in arterial wave speed (m*s^-1) 3 months Usual Vitamin D intake according to food questionnaire Baseline Change from baseline in adiponectin (pg*mL^-1) 3 months Change from baseline in serum calcium levels (mmol*L^-1) 3 months Change from baseline in Homeostatic model assessment Insulin Resistance 3 months Change from baseline in the ratio Low Density Lipoprotein/High Density Lipoprotein 3 months Change from baseline in Triglyceride levels 3 months Change from baseline in SuperOxyde Dismutase (U*gHb^-1) 3 months Change from baseline in TNF-alpha (pg*mL^-1) 3 months Change from baseline in carotid compliance (mm^2mmHg^-1) 3 months Change from baseline in blood 25(OH)D levels (mmol*L^-1) 3 months Change from baseline in blood parathyroid hormone levels (mmol*L^-1) 3 months Change from baseline in High sensitivity C-reactive protein (pg*mL^-1) 3 months Change from baseline in leptin (pg*mL^-1) 3 months Change from baseline in IL-6 (pg*mL^-1) 3 months Change from baseline in blood total protein levels (g*L^-1) 3 months Change from baseline in Acetylcholine-Cutaneous Blood Flow peak 3 months Change from baseline in Sodium nitroprussiate-Cutaneous Blood Flow peak (%) 3 months Change from baseline in Insulin-Cutaneous Blood Flow peak (%) 3 months
Trial Locations
- Locations (2)
CHRU de Nîmes - Hôpital Universitaire Carémeau
🇫🇷Nîmes Cedex 09, France
Institut Saint Pierre
🇫🇷Palavas-Les-Flots, France