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.
연구 개요
연구 유형
등록 (실제)
단계
- 해당 없음
연락처 및 위치
연구 장소
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Geneva, 스위스, 1205
- University Hospital of Geneva
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참여기준
자격 기준
공부할 수 있는 나이
건강한 자원 봉사자를 받아들입니다
연구 대상 성별
설명
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.
공부 계획
연구는 어떻게 설계됩니까?
디자인 세부사항
- 주 목적: 치료
- 할당: 무작위
- 중재 모델: 병렬 할당
- 마스킹: 하나의
무기와 개입
참가자 그룹 / 팔 |
개입 / 치료 |
|---|---|
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간섭 없음: 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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간섭 없음: 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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실험적: 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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실험적: Exercise 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. |
연구는 무엇을 측정합니까?
주요 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Bone mineral density and content
기간: 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
기간: 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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2차 결과 측정
결과 측정 |
측정값 설명 |
기간 |
|---|---|---|
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Anthropometrics
기간: 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
기간: 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
기간: Baseline
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Physical activity level by questionnaire and accelerometer
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Baseline
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Nutrition
기간: 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
기간: 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
기간: Baseline
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capillary HbA1c levels
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Baseline
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Systemic blood pressure
기간: 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
기간: 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
기간: 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
기간: 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
기간: 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
기간: at 9 months
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Total energy, proteins, lipids, carbohydrates and calcium intakes using food records
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at 9 months
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Circulating bone biomarkers levels
기간: at 9 months
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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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at 9 months
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Glycated Haemoglobin
기간: at 3 months
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capillary HbA1c levels
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at 3 months
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Glycated Haemoglobin
기간: at 6 months
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capillary HbA1c levels
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at 6 months
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Glycated Haemoglobin
기간: at 9 months
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capillary HbA1c levels
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at 9 months
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Systemic blood pressure
기간: 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
기간: 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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공동 작업자 및 조사자
수사관
- 수석 연구원: Farpour-Lambert Nathalie, PD, University Hospital, Geneva
간행물 및 유용한 링크
연구 기록 날짜
연구 주요 날짜
연구 시작
기본 완료 (실제)
연구 완료 (실제)
연구 등록 날짜
최초 제출
QC 기준을 충족하는 최초 제출
처음 게시됨 (추정)
연구 기록 업데이트
마지막 업데이트 게시됨 (추정)
QC 기준을 충족하는 마지막 업데이트 제출
마지막으로 확인됨
추가 정보
이 연구와 관련된 용어
키워드
기타 연구 ID 번호
- snf n°63164
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