Exercise Training Intervention in Children With Type 1 Diabetes (Diabex)
Impact of an Exercise Training Program on Bone Development and Cardiovascular Disease Risk Factors in Children With Type 1 Diabetes Mellitus
Type 1 diabetes mellitus (T1DM) is associated with multiple co-morbidities, such as hypertension, dyslipidemia, coronary heart disease and osteoporosis. The foundation of these conditions lays in childhood. Exercise is known to have a positive influence on bone mineral density (BMD) and some impact on cardiovascular disease risk factors in healthy children, but little is known about these associations in children with T1DM.
The main purpose of this study is to assess the effects of a 9-month weight-bearing exercise training program on skeletal development in children with T1DM, compared to healthy subjects. The second aim is to evaluate whether the program influences also cardiovascular diseases risk factors.
This is a randomized controlled study incorporating 30 children with T1DM and 30 healthy children. Both groups are randomly divided (1:1) in an exercise or a control group: 1) exercise diabetic, 2) controls diabetic, 3) exercise healthy, 4) controls healthy.
Exercise groups participate to an identical weight-bearing exercise training program 2 x 90 minutes per week and controls are relatively inactive.
Main measures include: total body, lumbar spine and hip BMD by DXA, body fat and fat-free mass, bone biomarkers levels, resting and ambulatory blood pressure and fasting blood lipids.
Aperçu de l'étude
Statut
Les conditions
Intervention / Traitement
Type d'étude
Inscription (Réel)
Phase
- N'est pas applicable
Contacts et emplacements
Lieux d'étude
-
-
-
Geneva, Suisse, 1205
- University Hospital of Geneva
-
-
Critères de participation
Critère d'éligibilité
Âges éligibles pour étudier
Accepte les volontaires sains
Sexes éligibles pour l'étude
La description
List of inclusion criteria for Type 1 diabetes patients:
1) disease for at least 1 year.
List of inclusion criteria for healthy subjects:
1) good general health and normal growth.
List of exclusion Criteria for all subjects:
- presence of other chronic disease, including thyroid disease;
- medications, hormones other than insulin, or calcium preparations taken in the preceding 6 months;
- presence of nephropathy;
- systemic disease or hospitalization for more than 2 weeks in the preceding year;
- less than 6 menstrual cycles in the past year for post-menarche girls;
- participation in competitive sport.
Plan d'étude
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Seul
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
|---|---|
|
Aucune intervention: Control Healthy
|
Exercise Diabetic and Healthy groups perform a similar training program including two exercise sessions per week, of 90 minutes each, during 9 months (excluding holidays) under supervision by physical education teachers and pediatricians. Sessions comprise various weight-bearing activities: rope skipping, jumping, ball games and gymnastics. Control groups are relatively inactive. |
|
Aucune intervention: Control Diabetic
|
Exercise Diabetic and Healthy groups perform a similar training program including two exercise sessions per week, of 90 minutes each, during 9 months (excluding holidays) under supervision by physical education teachers and pediatricians. Sessions comprise various weight-bearing activities: rope skipping, jumping, ball games and gymnastics. Control groups are relatively inactive. |
|
Expérimental: Exercise Diabetic
|
Exercise Diabetic and Healthy groups perform a similar training program including two exercise sessions per week, of 90 minutes each, during 9 months (excluding holidays) under supervision by physical education teachers and pediatricians. Sessions comprise various weight-bearing activities: rope skipping, jumping, ball games and gymnastics. Control groups are relatively inactive. |
|
Expérimental: Exercise Healthy
|
Exercise Diabetic and Healthy groups perform a similar training program including two exercise sessions per week, of 90 minutes each, during 9 months (excluding holidays) under supervision by physical education teachers and pediatricians. Sessions comprise various weight-bearing activities: rope skipping, jumping, ball games and gymnastics. Control groups are relatively inactive. |
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Bone mineral density and content
Délai: Baseline
|
Assessment of bone mineral density (BMD) and content (BMC) at the whole body, hip and lumbar spine using DXA.
|
Baseline
|
|
Bone mineral density and content
Délai: at 9 months
|
Assessment of bone mineral density (BMD) and content (BMC) at the whole body, hip and lumbar spine using DXA.
|
at 9 months
|
Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
|---|---|---|
|
Anthropometrics
Délai: Baseline
|
Body weight, height, body mass index and pubertal stage
|
Baseline
|
|
Blood lipids levels
Délai: Baseline
|
Fasting total cholesterol, LDL-Cholesterol, HDL-Cholesterol, triglycerides, lipoprotein (a), apolipoproteins A-I and B levels.
|
Baseline
|
|
Physical activity
Délai: Baseline
|
Physical activity level by questionnaire and accelerometer
|
Baseline
|
|
Nutrition
Délai: Baseline
|
Total energy, proteins, lipids, carbohydrates and calcium intakes using food records
|
Baseline
|
|
Circulating bone biomarkers levels
Délai: Baseline
|
Serum levels of beta-CrossLaps (CTX), N-MID-Osteocalcin (OC), N-Terminal Propeptide of Type I Collagen (PINP) and 25-OH-vitamin D (25-OH-D)
|
Baseline
|
|
Glycated Haemoglobin
Délai: Baseline
|
capillary HbA1c levels
|
Baseline
|
|
Systemic blood pressure
Délai: Baseline
|
Resting and 24-hour ambulatory systemic blood pressure monitoring
|
Baseline
|
|
Body composition
Délai: Baseline
|
Assessment of whole body and abdominal fat mass, and total fat-free mass using DXA.
|
Baseline
|
|
Anthropometrics
Délai: at 9 months
|
Body weight, height, body mass index and pubertal stage
|
at 9 months
|
|
Blood lipids levels
Délai: at 9 months
|
Fasting total cholesterol, LDL-Cholesterol, HDL-Cholesterol, triglycerides, lipoprotein (a), apolipoproteins A-I and B levels.
|
at 9 months
|
|
Physical activity
Délai: at 9 months
|
Physical activity level by questionnaire and accelerometer
|
at 9 months
|
|
Nutrition
Délai: at 9 months
|
Total energy, proteins, lipids, carbohydrates and calcium intakes using food records
|
at 9 months
|
|
Circulating bone biomarkers levels
Délai: at 9 months
|
Serum levels of beta-CrossLaps (CTX), N-MID-Osteocalcin (OC), N-Terminal Propeptide of Type I Collagen (PINP) and 25-OH-vitamin D (25-OH-D)
|
at 9 months
|
|
Glycated Haemoglobin
Délai: at 3 months
|
capillary HbA1c levels
|
at 3 months
|
|
Glycated Haemoglobin
Délai: at 6 months
|
capillary HbA1c levels
|
at 6 months
|
|
Glycated Haemoglobin
Délai: at 9 months
|
capillary HbA1c levels
|
at 9 months
|
|
Systemic blood pressure
Délai: at 9 months
|
Resting and 24-hour ambulatory systemic blood pressure monitoring
|
at 9 months
|
|
Body composition
Délai: at 9 months
|
Assessment of whole body and abdominal fat mass, and total fat-free mass using DXA.
|
at 9 months
|
Collaborateurs et enquêteurs
Parrainer
Collaborateurs
Les enquêteurs
- Chercheur principal: Farpour-Lambert Nathalie, PD, University Hospital, Geneva
Publications et liens utiles
Dates d'enregistrement des études
Dates principales de l'étude
Début de l'étude
Achèvement primaire (Réel)
Achèvement de l'étude (Réel)
Dates d'inscription aux études
Première soumission
Première soumission répondant aux critères de contrôle qualité
Première publication (Estimation)
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Estimation)
Dernière mise à jour soumise répondant aux critères de contrôle qualité
Dernière vérification
Plus d'information
Termes liés à cette étude
Mots clés
Termes MeSH pertinents supplémentaires
Autres numéros d'identification d'étude
- snf n°63164
Informations sur les médicaments et les dispositifs, documents d'étude
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