Exercise Training Intervention in Children With Type 1 Diabetes

Not Applicable

Completed

• Conditions: Type 1 Diabetes Mellitus
• Interventions: Behavioral: Exercise training program

• Registration Number: NCT01220479
• Lead Sponsor: 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.

Detailed Description

Not available

Study Timeline

• Study Start: 2001-09
• Primary Completion: 2008-12
• Study Completion: 2009-06
• Study First Submitted: 2010-05-04
• Status Verified: 2010-10
• Study First Submitted QC: 2010-10-13
• Last Update Submitted: 2010-10-13
• Study First Posted: 2010-10-14
• Last Update Posted: 2010-10-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 59

Inclusion Criteria

Not provided

Exclusion Criteria

Not provided

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Control Healthy	Exercise training program	-
Control Diabetic	Exercise training program	-
Exercise Diabetic	Exercise training program	-
Exercise Healthy	Exercise training program	-

Primary Outcome Measures

Name	Time	Method
Bone mineral density and content	at 9 months	Assessment of bone mineral density (BMD) and content (BMC) at the whole body, hip and lumbar spine using DXA.

Secondary Outcome Measures

Name	Time	Method
Anthropometrics	at 9 months	Body weight, height, body mass index and pubertal stage
Blood lipids levels	at 9 months	Fasting total cholesterol, LDL-Cholesterol, HDL-Cholesterol, triglycerides, lipoprotein (a), apolipoproteins A-I and B levels.
Physical activity	at 9 months	Physical activity level by questionnaire and accelerometer
Nutrition	at 9 months	Total energy, proteins, lipids, carbohydrates and calcium intakes using food records
Circulating bone biomarkers levels	at 9 months	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)
Glycated Haemoglobin	at 9 months	capillary HbA1c levels
Systemic blood pressure	at 9 months	Resting and 24-hour ambulatory systemic blood pressure monitoring
Body composition	at 9 months	Assessment of whole body and abdominal fat mass, and total fat-free mass using DXA.

Trial Locations

Locations (1)

University Hospital of Geneva; 🇨🇭 Geneva, Switzerland