- ICH GCP
- US-Register für klinische Studien
- Klinische Studie 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.
Studienübersicht
Status
Bedingungen
Intervention / Behandlung
Studientyp
Einschreibung (Tatsächlich)
Phase
- Unzutreffend
Kontakte und Standorte
Studienorte
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-
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Geneva, Schweiz, 1205
- University Hospital of Geneva
-
-
Teilnahmekriterien
Zulassungskriterien
Studienberechtigtes Alter
Akzeptiert gesunde Freiwillige
Studienberechtigte Geschlechter
Beschreibung
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.
Studienplan
Wie ist die Studie aufgebaut?
Designdetails
- Hauptzweck: Behandlung
- Zuteilung: Zufällig
- Interventionsmodell: Parallele Zuordnung
- Maskierung: Single
Waffen und Interventionen
Teilnehmergruppe / Arm |
Intervention / Behandlung |
---|---|
Kein Eingriff: 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. |
Kein Eingriff: 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. |
Was misst die Studie?
Primäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Bone mineral density and content
Zeitfenster: 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
Zeitfenster: 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
|
Sekundäre Ergebnismessungen
Ergebnis Maßnahme |
Maßnahmenbeschreibung |
Zeitfenster |
---|---|---|
Anthropometrics
Zeitfenster: Baseline
|
Body weight, height, body mass index and pubertal stage
|
Baseline
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Blood lipids levels
Zeitfenster: Baseline
|
Fasting total cholesterol, LDL-Cholesterol, HDL-Cholesterol, triglycerides, lipoprotein (a), apolipoproteins A-I and B levels.
|
Baseline
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Physical activity
Zeitfenster: Baseline
|
Physical activity level by questionnaire and accelerometer
|
Baseline
|
Nutrition
Zeitfenster: Baseline
|
Total energy, proteins, lipids, carbohydrates and calcium intakes using food records
|
Baseline
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Circulating bone biomarkers levels
Zeitfenster: 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
Zeitfenster: Baseline
|
capillary HbA1c levels
|
Baseline
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Systemic blood pressure
Zeitfenster: Baseline
|
Resting and 24-hour ambulatory systemic blood pressure monitoring
|
Baseline
|
Body composition
Zeitfenster: Baseline
|
Assessment of whole body and abdominal fat mass, and total fat-free mass using DXA.
|
Baseline
|
Anthropometrics
Zeitfenster: at 9 months
|
Body weight, height, body mass index and pubertal stage
|
at 9 months
|
Blood lipids levels
Zeitfenster: at 9 months
|
Fasting total cholesterol, LDL-Cholesterol, HDL-Cholesterol, triglycerides, lipoprotein (a), apolipoproteins A-I and B levels.
|
at 9 months
|
Physical activity
Zeitfenster: at 9 months
|
Physical activity level by questionnaire and accelerometer
|
at 9 months
|
Nutrition
Zeitfenster: at 9 months
|
Total energy, proteins, lipids, carbohydrates and calcium intakes using food records
|
at 9 months
|
Circulating bone biomarkers levels
Zeitfenster: 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
Zeitfenster: at 3 months
|
capillary HbA1c levels
|
at 3 months
|
Glycated Haemoglobin
Zeitfenster: at 6 months
|
capillary HbA1c levels
|
at 6 months
|
Glycated Haemoglobin
Zeitfenster: at 9 months
|
capillary HbA1c levels
|
at 9 months
|
Systemic blood pressure
Zeitfenster: at 9 months
|
Resting and 24-hour ambulatory systemic blood pressure monitoring
|
at 9 months
|
Body composition
Zeitfenster: at 9 months
|
Assessment of whole body and abdominal fat mass, and total fat-free mass using DXA.
|
at 9 months
|
Mitarbeiter und Ermittler
Sponsor
Mitarbeiter
Ermittler
- Hauptermittler: Farpour-Lambert Nathalie, PD, University Hospital, Geneva
Publikationen und hilfreiche Links
Studienaufzeichnungsdaten
Haupttermine studieren
Studienbeginn
Primärer Abschluss (Tatsächlich)
Studienabschluss (Tatsächlich)
Studienanmeldedaten
Zuerst eingereicht
Zuerst eingereicht, das die QC-Kriterien erfüllt hat
Zuerst gepostet (Schätzen)
Studienaufzeichnungsaktualisierungen
Letztes Update gepostet (Schätzen)
Letztes eingereichtes Update, das die QC-Kriterien erfüllt
Zuletzt verifiziert
Mehr Informationen
Begriffe im Zusammenhang mit dieser Studie
Schlüsselwörter
Zusätzliche relevante MeSH-Bedingungen
Andere Studien-ID-Nummern
- snf n°63164
Arzneimittel- und Geräteinformationen, Studienunterlagen
Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt
Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt
Produkt, das in den USA hergestellt und aus den USA exportiert wird
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