Exercise Training Intervention in Children With Type 1 Diabetes

Study Overview
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Brief Summary
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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.

Official Title
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Impact of an Exercise Training Program on Bone Development and Cardiovascular Disease Risk Factors in Children With Type 1 Diabetes Mellitus

Conditions
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Type 1 Diabetes Mellitus

Intervention / Treatment
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* Behavioral: Exercise training program


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 8 Years
Maximum Age: 16 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Single


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| No Intervention: Control Healthy<br> | Behavioral: Exercise training program<br>* 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.<br>|
| No Intervention: Control Diabetic<br> | Behavioral: Exercise training program<br>* 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.<br>|
| Experimental: Exercise Diabetic<br> | Behavioral: Exercise training program<br>* 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.<br>|
| Experimental: Exercise Healthy<br> | Behavioral: Exercise training program<br>* 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.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Bone mineral density and content | 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 | Assessment of bone mineral density (BMD) and content (BMC) at the whole body, hip and lumbar spine using DXA. | at 9 months | 

Secondary Outcome Measures

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

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Type 1 Diabetes, Bone mineral density, Growth, Cardiovascular diseases, Exercise, Training,, Child, Adolescent