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Exercise Training Intervention in Children With Type 1 Diabetes (Diabex)

13. oktober 2010 oppdatert av: University Hospital, Geneva

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.

Studieoversikt

Status

Fullført

Forhold

Intervensjon / Behandling

Studietype

Intervensjonell

Registrering (Faktiske)

59

Fase

  • Ikke aktuelt

Kontakter og plasseringer

Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.

Studiesteder

  • Sveits
      • Geneva, Sveits, 1205
        • University Hospital of Geneva

Deltakelseskriterier

Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.

Kvalifikasjonskriterier

Alder som er kvalifisert for studier

8 år til 16 år (Barn)

Tar imot friske frivillige

Nei

Kjønn som er kvalifisert for studier

Alle

Beskrivelse

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:

  1. presence of other chronic disease, including thyroid disease;
  2. medications, hormones other than insulin, or calcium preparations taken in the preceding 6 months;
  3. presence of nephropathy;
  4. systemic disease or hospitalization for more than 2 weeks in the preceding year;
  5. less than 6 menstrual cycles in the past year for post-menarche girls;
  6. participation in competitive sport.

Studieplan

Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.

Hvordan er studiet utformet?

Designdetaljer

  • Primært formål: Behandling
  • Tildeling: Randomisert
  • Intervensjonsmodell: Parallell tildeling
  • Masking: Enkelt

Våpen og intervensjoner

Deltakergruppe / Arm
Intervensjon / Behandling
Ingen inngripen: Control Healthy
Atferdsmessig: Exercise training program

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.
Ingen inngripen: Control Diabetic
Atferdsmessig: Exercise training program

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.
Eksperimentell: Exercise Diabetic
Atferdsmessig: Exercise training program

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.
Eksperimentell: Exercise Healthy
Atferdsmessig: Exercise training program

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.

Hva måler studien?

Primære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Bone mineral density and content
Tidsramme: 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
Tidsramme: 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

Sekundære resultatmål

Resultatmål
Tiltaksbeskrivelse
Tidsramme
Anthropometrics
Tidsramme: Baseline
Body weight, height, body mass index and pubertal stage
Baseline
Blood lipids levels
Tidsramme: Baseline
Fasting total cholesterol, LDL-Cholesterol, HDL-Cholesterol, triglycerides, lipoprotein (a), apolipoproteins A-I and B levels.
Baseline
Physical activity
Tidsramme: Baseline
Physical activity level by questionnaire and accelerometer
Baseline
Nutrition
Tidsramme: Baseline
Total energy, proteins, lipids, carbohydrates and calcium intakes using food records
Baseline
Circulating bone biomarkers levels
Tidsramme: 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
Tidsramme: Baseline
capillary HbA1c levels
Baseline
Systemic blood pressure
Tidsramme: Baseline
Resting and 24-hour ambulatory systemic blood pressure monitoring
Baseline
Body composition
Tidsramme: Baseline
Assessment of whole body and abdominal fat mass, and total fat-free mass using DXA.
Baseline
Anthropometrics
Tidsramme: at 9 months
Body weight, height, body mass index and pubertal stage
at 9 months
Blood lipids levels
Tidsramme: at 9 months
Fasting total cholesterol, LDL-Cholesterol, HDL-Cholesterol, triglycerides, lipoprotein (a), apolipoproteins A-I and B levels.
at 9 months
Physical activity
Tidsramme: at 9 months
Physical activity level by questionnaire and accelerometer
at 9 months
Nutrition
Tidsramme: at 9 months
Total energy, proteins, lipids, carbohydrates and calcium intakes using food records
at 9 months
Circulating bone biomarkers levels
Tidsramme: 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
Tidsramme: at 3 months
capillary HbA1c levels
at 3 months
Glycated Haemoglobin
Tidsramme: at 6 months
capillary HbA1c levels
at 6 months
Glycated Haemoglobin
Tidsramme: at 9 months
capillary HbA1c levels
at 9 months
Systemic blood pressure
Tidsramme: at 9 months
Resting and 24-hour ambulatory systemic blood pressure monitoring
at 9 months
Body composition
Tidsramme: at 9 months
Assessment of whole body and abdominal fat mass, and total fat-free mass using DXA.
at 9 months

Samarbeidspartnere og etterforskere

Det er her du vil finne personer og organisasjoner som er involvert i denne studien.

Sponsor

University Hospital, Geneva

Samarbeidspartnere

Swiss National Science Foundation

Etterforskere

  • Hovedetterforsker: Farpour-Lambert Nathalie, PD, University Hospital, Geneva

Publikasjoner og nyttige lenker

Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.

Generelle publikasjoner

Studierekorddatoer

Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.

Studer hoveddatoer

Studiestart

1. september 2001

Primær fullføring (Faktiske)

1. desember 2008

Studiet fullført (Faktiske)

1. juni 2009

Datoer for studieregistrering

Først innsendt

4. mai 2010

Først innsendt som oppfylte QC-kriteriene

13. oktober 2010

Først lagt ut (Anslag)

14. oktober 2010

Oppdateringer av studieposter

Sist oppdatering lagt ut (Anslag)

14. oktober 2010

Siste oppdatering sendt inn som oppfylte QC-kriteriene

13. oktober 2010

Sist bekreftet

1. oktober 2010

Mer informasjon

Begreper knyttet til denne studien

Nøkkelord

Ytterligere relevante MeSH-vilkår

Andre studie-ID-numre

  • snf n°63164

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Nei

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Nei

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