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

University Hospitals (UH)

Status: Completed

Conditions: Type 1 Diabetes Mellitus

Treatments: Behavioral: Exercise training program

Study type: Interventional

Funder types: Other

Identifiers

NCT01220479

snf n°63164

Details and patient eligibility

About

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.

Enrollment: 59 patients

Sex: All

Ages: 8 to 16 years old

Volunteers: Accepts Healthy Volunteers

Inclusion and exclusion criteria

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Single Blind

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59 participants in 4 patient groups

Control Healthy

No Intervention group

Treatment:

Behavioral: Exercise training program

Control Diabetic

No Intervention group

Treatment:

Behavioral: Exercise training program

Exercise Diabetic

Experimental group

Treatment:

Behavioral: Exercise training program

Exercise Healthy

Experimental group

Treatment:

Behavioral: Exercise training program