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.
Descripción general del estudio
Estado
Condiciones
Intervención / Tratamiento
Tipo de estudio
Inscripción (Actual)
Fase
- No aplica
Contactos y Ubicaciones
Ubicaciones de estudio
-
-
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Geneva, Suiza, 1205
- University Hospital of Geneva
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-
Criterios de participación
Criterio de elegibilidad
Edades elegibles para estudiar
Acepta Voluntarios Saludables
Géneros elegibles para el estudio
Descripción
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 de estudios
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Sin intervención: 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. |
|
Sin intervención: 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. |
|
Experimental: 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. |
|
Experimental: 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. |
¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Bone mineral density and content
Periodo de tiempo: 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
Periodo de tiempo: 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
|
Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
|
Anthropometrics
Periodo de tiempo: Baseline
|
Body weight, height, body mass index and pubertal stage
|
Baseline
|
|
Blood lipids levels
Periodo de tiempo: Baseline
|
Fasting total cholesterol, LDL-Cholesterol, HDL-Cholesterol, triglycerides, lipoprotein (a), apolipoproteins A-I and B levels.
|
Baseline
|
|
Physical activity
Periodo de tiempo: Baseline
|
Physical activity level by questionnaire and accelerometer
|
Baseline
|
|
Nutrition
Periodo de tiempo: Baseline
|
Total energy, proteins, lipids, carbohydrates and calcium intakes using food records
|
Baseline
|
|
Circulating bone biomarkers levels
Periodo de tiempo: 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
Periodo de tiempo: Baseline
|
capillary HbA1c levels
|
Baseline
|
|
Systemic blood pressure
Periodo de tiempo: Baseline
|
Resting and 24-hour ambulatory systemic blood pressure monitoring
|
Baseline
|
|
Body composition
Periodo de tiempo: Baseline
|
Assessment of whole body and abdominal fat mass, and total fat-free mass using DXA.
|
Baseline
|
|
Anthropometrics
Periodo de tiempo: at 9 months
|
Body weight, height, body mass index and pubertal stage
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at 9 months
|
|
Blood lipids levels
Periodo de tiempo: at 9 months
|
Fasting total cholesterol, LDL-Cholesterol, HDL-Cholesterol, triglycerides, lipoprotein (a), apolipoproteins A-I and B levels.
|
at 9 months
|
|
Physical activity
Periodo de tiempo: at 9 months
|
Physical activity level by questionnaire and accelerometer
|
at 9 months
|
|
Nutrition
Periodo de tiempo: at 9 months
|
Total energy, proteins, lipids, carbohydrates and calcium intakes using food records
|
at 9 months
|
|
Circulating bone biomarkers levels
Periodo de tiempo: 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
Periodo de tiempo: at 3 months
|
capillary HbA1c levels
|
at 3 months
|
|
Glycated Haemoglobin
Periodo de tiempo: at 6 months
|
capillary HbA1c levels
|
at 6 months
|
|
Glycated Haemoglobin
Periodo de tiempo: at 9 months
|
capillary HbA1c levels
|
at 9 months
|
|
Systemic blood pressure
Periodo de tiempo: at 9 months
|
Resting and 24-hour ambulatory systemic blood pressure monitoring
|
at 9 months
|
|
Body composition
Periodo de tiempo: at 9 months
|
Assessment of whole body and abdominal fat mass, and total fat-free mass using DXA.
|
at 9 months
|
Colaboradores e Investigadores
Patrocinador
Colaboradores
Investigadores
- Investigador principal: Farpour-Lambert Nathalie, PD, University Hospital, Geneva
Publicaciones y enlaces útiles
Fechas de registro del estudio
Fechas importantes del estudio
Inicio del estudio
Finalización primaria (Actual)
Finalización del estudio (Actual)
Fechas de registro del estudio
Enviado por primera vez
Primero enviado que cumplió con los criterios de control de calidad
Publicado por primera vez (Estimar)
Actualizaciones de registros de estudio
Última actualización publicada (Estimar)
Última actualización enviada que cumplió con los criterios de control de calidad
Última verificación
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- snf n°63164
Información sobre medicamentos y dispositivos, documentos del estudio
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Ensayos clínicos sobre Diabetes mellitus tipo 1
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University of California, San FranciscoJuvenile Diabetes Research FoundationTerminadoDiabetes mellitus tipo 1 | Diabetes Mellitus, Tipo I | Diabetes mellitus insulinodependiente 1 | Diabetes Mellitus, Insulino-Dependiente, 1 | IDDMEstados Unidos, Australia
-
University of Colorado, DenverMassachusetts General Hospital; Beta Bionics, Inc.TerminadoDiabetes Mellitus, Tipo 1 | Diabetes tipo 1 | Diabetes tipo 1 | Diabetes mellitus tipo 1 | Diabetes autoinmune | Diabetes Mellitus, Insulino-Dependiente | Diabetes de inicio juvenil | Diabetes Autoinmune | Diabetes mellitus insulinodependiente 1 | Diabetes Mellitus, Insulino-Dependiente, 1 | Diabetes Mellitus... y otras condicionesEstados Unidos
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Capillary Biomedical, Inc.TerminadoDiabetes Mellitus, Tipo 1 | Diabetes tipo 1 | Diabetes mellitus tipo 1 | Diabetes Mellitus, Insulino-Dependiente, 1Australia
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Spiden AGDCB Research AGReclutamientoDiabetes mellitus tipo 1 | Diabetes mellitus tipo 1 con hipoglucemia | Diabetes mellitus tipo 1 con hiperglucemiaSuiza
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Instytut Diabetologii Sp. z o.o.National Center for Research and Development, Poland; Nalecz Institute of Biocybernetics...DesconocidoDiabetes mellitus tipo 1 con hiperglucemia | Diabetes mellitus tipo 1 con hipoglucemiaPolonia
-
Capillary Biomedical, Inc.TerminadoDiabetes tipo 1 | Diabetes mellitus tipo 1 | Diabetes Mellitus, Tipo I | Diabetes Mellitus, Insulino-Dependiente, 1 | IDDMAustria
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National Institute of Allergy and Infectious Diseases...PPD; Rho Federal Systems Division, Inc.; Immune Tolerance Network (ITN)TerminadoDiabetes mellitus tipo 1 | DM1 | DT1 | Diabetes mellitus tipo 1 de nueva apariciónEstados Unidos, Australia
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SanofiTerminadoDiabetes Mellitus Tipo 1-Diabetes Mellitus Tipo 2Hungría, Federación Rusa, Alemania, Polonia, Japón, Estados Unidos, Finlandia
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Hoffmann-La RocheRoche DiagnosticsTerminadoDiabetes Mellitus Tipo 2, Diabetes Mellitus Tipo 1Alemania
Ensayos clínicos sobre Exercise training program
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