- ICH GCP
- Registro degli studi clinici negli Stati Uniti
- Sperimentazione clinica NCT01220479
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.
Panoramica dello studio
Stato
Condizioni
Intervento / Trattamento
Tipo di studio
Iscrizione (Effettivo)
Fase
- Non applicabile
Contatti e Sedi
Luoghi di studio
-
-
-
Geneva, Svizzera, 1205
- University Hospital of Geneva
-
-
Criteri di partecipazione
Criteri di ammissibilità
Età idonea allo studio
Accetta volontari sani
Sessi ammissibili allo studio
Descrizione
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.
Piano di studio
Come è strutturato lo studio?
Dettagli di progettazione
- Scopo principale: Trattamento
- Assegnazione: Randomizzato
- Modello interventistico: Assegnazione parallela
- Mascheramento: Separare
Armi e interventi
Gruppo di partecipanti / Arm |
Intervento / Trattamento |
---|---|
Nessun intervento: 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. |
Nessun intervento: 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. |
Sperimentale: 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. |
Sperimentale: 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. |
Cosa sta misurando lo studio?
Misure di risultato primarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Bone mineral density and content
Lasso di tempo: 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
Lasso di tempo: 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
|
Misure di risultato secondarie
Misura del risultato |
Misura Descrizione |
Lasso di tempo |
---|---|---|
Anthropometrics
Lasso di tempo: Baseline
|
Body weight, height, body mass index and pubertal stage
|
Baseline
|
Blood lipids levels
Lasso di tempo: Baseline
|
Fasting total cholesterol, LDL-Cholesterol, HDL-Cholesterol, triglycerides, lipoprotein (a), apolipoproteins A-I and B levels.
|
Baseline
|
Physical activity
Lasso di tempo: Baseline
|
Physical activity level by questionnaire and accelerometer
|
Baseline
|
Nutrition
Lasso di tempo: Baseline
|
Total energy, proteins, lipids, carbohydrates and calcium intakes using food records
|
Baseline
|
Circulating bone biomarkers levels
Lasso di tempo: 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
Lasso di tempo: Baseline
|
capillary HbA1c levels
|
Baseline
|
Systemic blood pressure
Lasso di tempo: Baseline
|
Resting and 24-hour ambulatory systemic blood pressure monitoring
|
Baseline
|
Body composition
Lasso di tempo: Baseline
|
Assessment of whole body and abdominal fat mass, and total fat-free mass using DXA.
|
Baseline
|
Anthropometrics
Lasso di tempo: at 9 months
|
Body weight, height, body mass index and pubertal stage
|
at 9 months
|
Blood lipids levels
Lasso di tempo: at 9 months
|
Fasting total cholesterol, LDL-Cholesterol, HDL-Cholesterol, triglycerides, lipoprotein (a), apolipoproteins A-I and B levels.
|
at 9 months
|
Physical activity
Lasso di tempo: at 9 months
|
Physical activity level by questionnaire and accelerometer
|
at 9 months
|
Nutrition
Lasso di tempo: at 9 months
|
Total energy, proteins, lipids, carbohydrates and calcium intakes using food records
|
at 9 months
|
Circulating bone biomarkers levels
Lasso di tempo: 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
Lasso di tempo: at 3 months
|
capillary HbA1c levels
|
at 3 months
|
Glycated Haemoglobin
Lasso di tempo: at 6 months
|
capillary HbA1c levels
|
at 6 months
|
Glycated Haemoglobin
Lasso di tempo: at 9 months
|
capillary HbA1c levels
|
at 9 months
|
Systemic blood pressure
Lasso di tempo: at 9 months
|
Resting and 24-hour ambulatory systemic blood pressure monitoring
|
at 9 months
|
Body composition
Lasso di tempo: at 9 months
|
Assessment of whole body and abdominal fat mass, and total fat-free mass using DXA.
|
at 9 months
|
Collaboratori e investigatori
Sponsor
Collaboratori
Investigatori
- Investigatore principale: Farpour-Lambert Nathalie, PD, University Hospital, Geneva
Pubblicazioni e link utili
Studiare le date dei record
Studia le date principali
Inizio studio
Completamento primario (Effettivo)
Completamento dello studio (Effettivo)
Date di iscrizione allo studio
Primo inviato
Primo inviato che soddisfa i criteri di controllo qualità
Primo Inserito (Stima)
Aggiornamenti dei record di studio
Ultimo aggiornamento pubblicato (Stima)
Ultimo aggiornamento inviato che soddisfa i criteri QC
Ultimo verificato
Maggiori informazioni
Termini relativi a questo studio
Parole chiave
Termini MeSH pertinenti aggiuntivi
Altri numeri di identificazione dello studio
- snf n°63164
Informazioni su farmaci e dispositivi, documenti di studio
Studia un prodotto farmaceutico regolamentato dalla FDA degli Stati Uniti
Studia un dispositivo regolamentato dalla FDA degli Stati Uniti
prodotto fabbricato ed esportato dagli Stati Uniti
Queste informazioni sono state recuperate direttamente dal sito web clinicaltrials.gov senza alcuna modifica. In caso di richieste di modifica, rimozione o aggiornamento dei dettagli dello studio, contattare register@clinicaltrials.gov. Non appena verrà implementata una modifica su clinicaltrials.gov, questa verrà aggiornata automaticamente anche sul nostro sito web .
Prove cliniche su Exercise training program
-
University of ManitobaCanadian Institutes of Health Research (CIHR)ReclutamentoViolenza, domesticaCanada
-
IWK Health CentreCanadian Institutes of Health Research (CIHR)CompletatoDisturbo d'ansiaCanada
-
NYU Langone HealthNational Institute on Aging (NIA)Reclutamento
-
Marmara UniversityAttivo, non reclutanteAttività fisica | Tempo dello schermo | Bambino, scuola maternaTacchino
-
Koc University HospitalCompletatoCompassione Stanchezza
-
The University of QueenslandRestorative Outcomes Australia; Department of Education, Queensland; Queensland... e altri collaboratoriSconosciutoComportamento antisociale | Frequenza scolastica | Dipendenza dal benessereAustralia
-
University of Arkansas, FayettevilleNational Cancer Institute (NCI); University of California, Los Angeles; Thomas... e altri collaboratoriAttivo, non reclutanteMalattie prevenibili da vaccino | Papilloma-virus umanoStati Uniti
-
Misook L. ChungCompletato
-
McGill UniversitySave the Children; European Network of Foundations Children and Violence Evaluation... e altri collaboratoriSconosciutoAbuso di minori | Relazioni genitori-figliCanada
-
Cefaly TechnologyCompletatoEmicraniaStati Uniti