Impact of an Exercise Training Program on Bone Development and Cardiovascular Disease Risk Factors in Children With Type 1 Diabetes Mellitus
Trial Snapshot
- Phase
- Not Applicable
- Status
- Completed
- Sponsor
- University Hospital, Geneva
- Enrollment
- 59
- Locations
- 1
- Primary Endpoint
- Bone mineral density and content
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Outcomes Assessor)
Eligibility Criteria
- Ages
- 8 Years to 16 Years (Child)
- Sex
- All
- Accepts Healthy Volunteers
- Yes
Inclusion Criteria
- •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.
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.
Arms & Interventions
Control Diabetic
Intervention: Exercise training program (Behavioral)
Control Healthy
Intervention: Exercise training program (Behavioral)
Exercise Diabetic
Intervention: Exercise training program (Behavioral)
Exercise Healthy
Intervention: Exercise training program (Behavioral)
Outcomes
Primary Outcomes
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.
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.
Secondary Outcomes
- Anthropometrics(at 9 months)
- Blood lipids levels(at 9 months)
- Physical activity(at 9 months)
- Nutrition(at 9 months)
- Circulating bone biomarkers levels(at 9 months)
- Glycated Haemoglobin(at 9 months)
- Systemic blood pressure(at 9 months)
- Body composition(at 9 months)
- Anthropometrics(Baseline)
- Blood lipids levels(Baseline)
- Physical activity(Baseline)
- Nutrition(Baseline)
- Circulating bone biomarkers levels(Baseline)
- Glycated Haemoglobin(Baseline)
- Systemic blood pressure(Baseline)
- Body composition(Baseline)
- Glycated Haemoglobin(at 3 months)
- Glycated Haemoglobin(at 6 months)