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| Name | Class |
|---|---|
| Swiss National Science Foundation | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Control Healthy | No Intervention |
| |
| Control Diabetic | No Intervention |
| |
| Exercise Diabetic | Experimental |
| |
| Exercise Healthy | Experimental |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Exercise training program | Behavioral | 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. |
| 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 |
| 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. |
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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:
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| Name | Affiliation | Role |
|---|---|---|
| Farpour-Lambert Nathalie, PD | University Hospital, Geneva | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| University Hospital of Geneva | Geneva | Canton of Geneva | 1205 | Switzerland |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 22246217 | Derived | Maggio AB, Rizzoli RR, Marchand LM, Ferrari S, Beghetti M, Farpour-Lambert NJ. Physical activity increases bone mineral density in children with type 1 diabetes. Med Sci Sports Exerc. 2012 Jul;44(7):1206-11. doi: 10.1249/MSS.0b013e3182496a25. |
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| ID | Term |
|---|---|
| D003922 | Diabetes Mellitus, Type 1 |
| D002318 | Cardiovascular Diseases |
| D009043 | Motor Activity |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
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| 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 |
| D004700 | Endocrine System Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D001519 | Behavior |