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

Exercise Training Intervention in Children With Type 1 Diabetes

Sponsors

Lead sponsor: University Hospital, Geneva

Collaborator: Swiss National Science Foundation

Source University Hospital, Geneva
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.

Overall Status Completed
Start Date September 2001
Completion Date June 2009
Primary Completion Date December 2008
Phase N/A
Study Type Interventional
Primary Outcome
Measure Time Frame
Bone mineral density and content Baseline
Bone mineral density and content at 9 months
Secondary Outcome
Measure Time Frame
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
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 3 months
Glycated Haemoglobin at 6 months
Glycated Haemoglobin at 9 months
Systemic blood pressure at 9 months
Body composition at 9 months
Enrollment 59
Condition
Intervention

Intervention type: Behavioral

Intervention name: Exercise training program

Description: 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.

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.

Gender: All

Minimum age: 8 Years

Maximum age: 16 Years

Healthy volunteers: Accepts Healthy Volunteers

Overall Official
Last Name Role Affiliation
Farpour-Lambert Nathalie, PD Principal Investigator University Hospital, Geneva
Location
facility
University Hospital of Geneva
Location Countries

Switzerland

Verification Date

October 2010

Responsible Party

Name title: Farpour-Lambert Nathalie

Organization: University Hospital of Geneva

Keywords
Has Expanded Access No
Condition Browse
Number Of Arms 4
Arm Group

Arm group label: Control Healthy

Arm group type: No Intervention

Arm group label: Control Diabetic

Arm group type: No Intervention

Arm group label: Exercise Diabetic

Arm group type: Experimental

Arm group label: Exercise Healthy

Arm group type: Experimental

Acronym Diabex
Study Design Info

Allocation: Randomized

Intervention model: Parallel Assignment

Primary purpose: Treatment

Masking: Single (Outcomes Assessor)

Source: ClinicalTrials.gov