Exercise Training Intervention in Children With Type 1 Diabetes

Type 1 Diabetes Mellitus Clinical Trial

— Diabex  

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01220479
• Other study ID #: snf n°63164
• Status: Completed
• Phase: N/A
• First received: May 4, 2010
• Last updated: October 13, 2010
• Start date: September 2001
• Est. completion date: June 2009

Study information

• Verified date: October 2010
• Source: University Hospital, Geneva
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Ethikkommission
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 59
• Est. completion date: June 2009
• Est. primary completion date: December 2008
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 8 Years to 16 Years

Eligibility

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.

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Single Blind (Outcomes Assessor), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Cardiovascular Diseases
• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes Mellitus

Intervention

Behavioral:
• Exercise training program
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.

Locations

Country	Name	City	State
Switzerland	University Hospital of Geneva	Geneva

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Geneva	Swiss National Science Foundation

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Bone mineral density and content	Assessment of bone mineral density (BMD) and content (BMC) at the whole body, hip and lumbar spine using DXA.	Baseline	No
Primary	Bone mineral density and content	Assessment of bone mineral density (BMD) and content (BMC) at the whole body, hip and lumbar spine using DXA.	at 9 months	No
Secondary	Anthropometrics	Body weight, height, body mass index and pubertal stage	Baseline	No
Secondary	Blood lipids levels	Fasting total cholesterol, LDL-Cholesterol, HDL-Cholesterol, triglycerides, lipoprotein (a), apolipoproteins A-I and B levels.	Baseline	No
Secondary	Physical activity	Physical activity level by questionnaire and accelerometer	Baseline	No
Secondary	Nutrition	Total energy, proteins, lipids, carbohydrates and calcium intakes using food records	Baseline	No
Secondary	Circulating bone biomarkers levels	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)	Baseline	No
Secondary	Glycated Haemoglobin	capillary HbA1c levels	Baseline	No
Secondary	Systemic blood pressure	Resting and 24-hour ambulatory systemic blood pressure monitoring	Baseline	No
Secondary	Body composition	Assessment of whole body and abdominal fat mass, and total fat-free mass using DXA.	Baseline	No
Secondary	Anthropometrics	Body weight, height, body mass index and pubertal stage	at 9 months	No
Secondary	Blood lipids levels	Fasting total cholesterol, LDL-Cholesterol, HDL-Cholesterol, triglycerides, lipoprotein (a), apolipoproteins A-I and B levels.	at 9 months	No
Secondary	Physical activity	Physical activity level by questionnaire and accelerometer	at 9 months	No
Secondary	Nutrition	Total energy, proteins, lipids, carbohydrates and calcium intakes using food records	at 9 months	No
Secondary	Circulating bone biomarkers levels	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)	at 9 months	No
Secondary	Glycated Haemoglobin	capillary HbA1c levels	at 3 months	No
Secondary	Glycated Haemoglobin	capillary HbA1c levels	at 6 months	No
Secondary	Glycated Haemoglobin	capillary HbA1c levels	at 9 months	No
Secondary	Systemic blood pressure	Resting and 24-hour ambulatory systemic blood pressure monitoring	at 9 months	No
Secondary	Body composition	Assessment of whole body and abdominal fat mass, and total fat-free mass using DXA.	at 9 months	No