Clinical trial NCT01220479: Exercise Training Intervention in Children With Type 1 Diabetes
Official title: Impact of an Exercise Training Program on Bone Development and Cardiovascular Disease Risk Factors in Children With Type 1 Diabetes Mellitus
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Type 1 Diabetes Mellitus
Keywords: Type 1 Diabetes, Bone mineral density, Growth
Cardiovascular diseases, Exercise, Training,
Child, Adolescent
Lead sponsor: University Hospital, Geneva
Sponsor class: OTHER
Collaborators: name: Swiss National Science Foundation
First posted: 2010-10-14
Enrollment: 59
Sex: ALL
Minimum age (years): 8
Maximum age (years): 16
Standard ages: CHILD
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief summary: 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.


Eligibility 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.

Primary outcomes:
measure: Bone mineral density and content
timeFrame: Baseline
measure: Bone mineral density and content
timeFrame: at 9 months
Secondary outcomes:
measure: Anthropometrics
timeFrame: Baseline
measure: Blood lipids levels
timeFrame: Baseline
measure: Physical activity
timeFrame: Baseline
measure: Nutrition
timeFrame: Baseline
measure: Circulating bone biomarkers levels
timeFrame: Baseline
measure: Glycated Haemoglobin
timeFrame: Baseline
measure: Systemic blood pressure
timeFrame: Baseline
measure: Body composition
timeFrame: Baseline
measure: Anthropometrics
timeFrame: at 9 months
measure: Blood lipids levels
timeFrame: at 9 months
measure: Physical activity
timeFrame: at 9 months
measure: Nutrition
timeFrame: at 9 months
measure: Circulating bone biomarkers levels
timeFrame: at 9 months
measure: Glycated Haemoglobin
timeFrame: at 3 months
measure: Glycated Haemoglobin
timeFrame: at 6 months
measure: Glycated Haemoglobin
timeFrame: at 9 months
measure: Systemic blood pressure
timeFrame: at 9 months
measure: Body composition
timeFrame: at 9 months
Other outcomes:
Locations:
city: Geneva
country: Switzerland
facility: University Hospital of Geneva
Study officials:
affiliation: University Hospital, Geneva
name: Farpour-Lambert Nathalie, PD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.