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Completed

NCT Number: NCT01220479

Exercise Training Intervention in Children With Type 1 Diabetes

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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Key information

Conditions

Type 1 Diabetes Mellitus Autoimmune Diseases Behavior Cardiovascular Diseases Diabetes Mellitus Diabetes Mellitus, Type 1 Endocrine System Diseases Glucose Metabolism Disorders Immune System Diseases Metabolic Diseases Motor Activity Nutritional and Metabolic Diseases

Age range

8 year–16 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

University Hospital of Geneva

Geneva, Canton of Geneva, 1205, Switzerland

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

List of inclusion criteria for Type 1 diabetes patients:

  • disease for at least 1 year.

List of inclusion criteria for healthy subjects:

  • 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.

Treatment and study plan

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.

Primary outcomes

  1. Bone mineral density and content

    Time frame: Baseline

    Assessment of bone mineral density (BMD) and content (BMC) at the whole body, hip and lumbar spine using DXA.

  2. Bone mineral density and content

    Time frame: at 9 months

    Assessment of bone mineral density (BMD) and content (BMC) at the whole body, hip and lumbar spine using DXA.

Secondary outcomes

  1. Anthropometrics

    Time frame: Baseline

    Body weight, height, body mass index and pubertal stage

  2. Blood lipids levels

    Time frame: Baseline

    Fasting total cholesterol, LDL-Cholesterol, HDL-Cholesterol, triglycerides, lipoprotein (a), apolipoproteins A-I and B levels.

  3. Physical activity

    Time frame: Baseline

    Physical activity level by questionnaire and accelerometer

  4. Nutrition

    Time frame: Baseline

    Total energy, proteins, lipids, carbohydrates and calcium intakes using food records

  5. Circulating bone biomarkers levels

    Time frame: 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)

  6. Glycated Haemoglobin

    Time frame: Baseline

    capillary HbA1c levels

  7. Systemic blood pressure

    Time frame: Baseline

    Resting and 24-hour ambulatory systemic blood pressure monitoring

  8. Body composition

    Time frame: Baseline

    Assessment of whole body and abdominal fat mass, and total fat-free mass using DXA.

  9. Anthropometrics

    Time frame: at 9 months

    Body weight, height, body mass index and pubertal stage

  10. Blood lipids levels

    Time frame: at 9 months

    Fasting total cholesterol, LDL-Cholesterol, HDL-Cholesterol, triglycerides, lipoprotein (a), apolipoproteins A-I and B levels.

  11. Physical activity

    Time frame: at 9 months

    Physical activity level by questionnaire and accelerometer

  12. Nutrition

    Time frame: at 9 months

    Total energy, proteins, lipids, carbohydrates and calcium intakes using food records

  13. Circulating bone biomarkers levels

    Time frame: 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)

  14. Glycated Haemoglobin

    Time frame: at 3 months

    capillary HbA1c levels

  15. Glycated Haemoglobin

    Time frame: at 6 months

    capillary HbA1c levels

  16. Glycated Haemoglobin

    Time frame: at 9 months

    capillary HbA1c levels

  17. Systemic blood pressure

    Time frame: at 9 months

    Resting and 24-hour ambulatory systemic blood pressure monitoring

  18. Body composition

    Time frame: at 9 months

    Assessment of whole body and abdominal fat mass, and total fat-free mass using DXA.

Sponsors and collaborators

Lead sponsor

University Hospital, Geneva

Other

Collaborators

  • Swiss National Science Foundation

Registry information

Official study title

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

Acronym: Diabex

Important dates

Study start
2001
Primary completion
2008
Study completion
2009
First posted
Oct 14, 2010
Registry last updated
Oct 14, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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