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

13. oktober 2010 opdateret af: 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.

Studieoversigt

Status

Afsluttet

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Faktiske)

59

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiesteder

  • Schweiz
      • Geneva, Schweiz, 1205
        • University Hospital of Geneva

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

8 år til 16 år (Barn)

Tager imod sunde frivillige

Ingen

Køn, der er berettiget til at studere

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

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Ingen indgriben: Control Healthy
Adfærdsmæssigt: 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 indgriben: Control Diabetic
Adfærdsmæssigt: 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.
Eksperimentel: Exercise Diabetic
Adfærdsmæssigt: 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.
Eksperimentel: Exercise Healthy
Adfærdsmæssigt: 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.

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
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
Foranstaltningsbeskrivelse
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

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University Hospital, Geneva

Samarbejdspartnere

Swiss National Science Foundation

Efterforskere

  • Ledende efterforsker: Farpour-Lambert Nathalie, PD, University Hospital, Geneva

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart

1. september 2001

Primær færdiggørelse (Faktiske)

1. december 2008

Studieafslutning (Faktiske)

1. juni 2009

Datoer for studieregistrering

Først indsendt

4. maj 2010

Først indsendt, der opfyldte QC-kriterier

13. oktober 2010

Først opslået (Skøn)

14. oktober 2010

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Skøn)

14. oktober 2010

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

13. oktober 2010

Sidst verificeret

1. oktober 2010

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • snf n°63164

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