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.
Przegląd badań
Status
Warunki
Interwencja / Leczenie
Typ studiów
Zapisy (Rzeczywisty)
Faza
- Nie dotyczy
Kontakty i lokalizacje
Lokalizacje studiów
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Geneva, Szwajcaria, 1205
- University Hospital of Geneva
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Kryteria uczestnictwa
Kryteria kwalifikacji
Wiek uprawniający do nauki
Akceptuje zdrowych ochotników
Płeć kwalifikująca się do nauki
Opis
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 studiów
Jak projektuje się badanie?
Szczegóły projektu
- Główny cel: Leczenie
- Przydział: Randomizowane
- Model interwencyjny: Przydział równoległy
- Maskowanie: Pojedynczy
Broń i interwencje
Grupa uczestników / Arm |
Interwencja / Leczenie |
|---|---|
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Brak interwencji: Control Healthy
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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. |
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Brak interwencji: Control Diabetic
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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. |
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Eksperymentalny: Exercise Diabetic
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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. |
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Eksperymentalny: 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. |
Co mierzy badanie?
Podstawowe miary wyniku
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Bone mineral density and content
Ramy czasowe: Baseline
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Assessment of bone mineral density (BMD) and content (BMC) at the whole body, hip and lumbar spine using DXA.
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Baseline
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Bone mineral density and content
Ramy czasowe: at 9 months
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Assessment of bone mineral density (BMD) and content (BMC) at the whole body, hip and lumbar spine using DXA.
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at 9 months
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Miary wyników drugorzędnych
Miara wyniku |
Opis środka |
Ramy czasowe |
|---|---|---|
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Anthropometrics
Ramy czasowe: Baseline
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Body weight, height, body mass index and pubertal stage
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Baseline
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Blood lipids levels
Ramy czasowe: Baseline
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Fasting total cholesterol, LDL-Cholesterol, HDL-Cholesterol, triglycerides, lipoprotein (a), apolipoproteins A-I and B levels.
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Baseline
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Physical activity
Ramy czasowe: Baseline
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Physical activity level by questionnaire and accelerometer
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Baseline
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Nutrition
Ramy czasowe: Baseline
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Total energy, proteins, lipids, carbohydrates and calcium intakes using food records
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Baseline
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Circulating bone biomarkers levels
Ramy czasowe: Baseline
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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)
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Baseline
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Glycated Haemoglobin
Ramy czasowe: Baseline
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capillary HbA1c levels
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Baseline
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Systemic blood pressure
Ramy czasowe: Baseline
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Resting and 24-hour ambulatory systemic blood pressure monitoring
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Baseline
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Body composition
Ramy czasowe: Baseline
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Assessment of whole body and abdominal fat mass, and total fat-free mass using DXA.
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Baseline
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Anthropometrics
Ramy czasowe: at 9 months
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Body weight, height, body mass index and pubertal stage
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at 9 months
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Blood lipids levels
Ramy czasowe: at 9 months
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Fasting total cholesterol, LDL-Cholesterol, HDL-Cholesterol, triglycerides, lipoprotein (a), apolipoproteins A-I and B levels.
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at 9 months
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Physical activity
Ramy czasowe: at 9 months
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Physical activity level by questionnaire and accelerometer
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at 9 months
|
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Nutrition
Ramy czasowe: at 9 months
|
Total energy, proteins, lipids, carbohydrates and calcium intakes using food records
|
at 9 months
|
|
Circulating bone biomarkers levels
Ramy czasowe: 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)
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at 9 months
|
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Glycated Haemoglobin
Ramy czasowe: at 3 months
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capillary HbA1c levels
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at 3 months
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Glycated Haemoglobin
Ramy czasowe: at 6 months
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capillary HbA1c levels
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at 6 months
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Glycated Haemoglobin
Ramy czasowe: at 9 months
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capillary HbA1c levels
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at 9 months
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Systemic blood pressure
Ramy czasowe: at 9 months
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Resting and 24-hour ambulatory systemic blood pressure monitoring
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at 9 months
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Body composition
Ramy czasowe: at 9 months
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Assessment of whole body and abdominal fat mass, and total fat-free mass using DXA.
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at 9 months
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Współpracownicy i badacze
Sponsor
Współpracownicy
Śledczy
- Główny śledczy: Farpour-Lambert Nathalie, PD, University Hospital, Geneva
Publikacje i pomocne linki
Daty zapisu na studia
Główne daty studiów
Rozpoczęcie studiów
Zakończenie podstawowe (Rzeczywisty)
Ukończenie studiów (Rzeczywisty)
Daty rejestracji na studia
Pierwszy przesłany
Pierwszy przesłany, który spełnia kryteria kontroli jakości
Pierwszy wysłany (Oszacować)
Aktualizacje rekordów badań
Ostatnia wysłana aktualizacja (Oszacować)
Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości
Ostatnia weryfikacja
Więcej informacji
Terminy związane z tym badaniem
Słowa kluczowe
Dodatkowe istotne warunki MeSH
Inne numery identyfikacyjne badania
- snf n°63164
Informacje o lekach i urządzeniach, dokumenty badawcze
Bada produkt leczniczy regulowany przez amerykańską FDA
Bada produkt urządzenia regulowany przez amerykańską FDA
produkt wyprodukowany i wyeksportowany z USA
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