Exercise Training Intervention in Children With Type 1 Diabetes (Diabex)

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

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 Overview

• Status: Completed
• Conditions: Type 1 Diabetes Mellitus
• Intervention / Treatment: Behavioral: Exercise training program

• Study Type: Interventional
• Enrollment (Actual): 59
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Switzerland
  • Geneva, Switzerland, 1205
    • University Hospital of Geneva

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 8 years to 16 years (Child)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Single

Number of Arms

4

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
No Intervention: Control Healthy	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.
No Intervention: Control Diabetic	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.
Experimental: Exercise Diabetic	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.
Experimental: Exercise Healthy	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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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
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

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Anthropometrics	Body weight, height, body mass index and pubertal stage	Baseline
Blood lipids levels	Fasting total cholesterol, LDL-Cholesterol, HDL-Cholesterol, triglycerides, lipoprotein (a), apolipoproteins A-I and B levels.	Baseline
Physical activity	Physical activity level by questionnaire and accelerometer	Baseline
Nutrition	Total energy, proteins, lipids, carbohydrates and calcium intakes using food records	Baseline
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
Glycated Haemoglobin	capillary HbA1c levels	Baseline
Systemic blood pressure	Resting and 24-hour ambulatory systemic blood pressure monitoring	Baseline
Body composition	Assessment of whole body and abdominal fat mass, and total fat-free mass using DXA.	Baseline
Anthropometrics	Body weight, height, body mass index and pubertal stage	at 9 months
Blood lipids levels	Fasting total cholesterol, LDL-Cholesterol, HDL-Cholesterol, triglycerides, lipoprotein (a), apolipoproteins A-I and B levels.	at 9 months
Physical activity	Physical activity level by questionnaire and accelerometer	at 9 months
Nutrition	Total energy, proteins, lipids, carbohydrates and calcium intakes using food records	at 9 months
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
Glycated Haemoglobin	capillary HbA1c levels	at 3 months
Glycated Haemoglobin	capillary HbA1c levels	at 6 months
Glycated Haemoglobin	capillary HbA1c levels	at 9 months
Systemic blood pressure	Resting and 24-hour ambulatory systemic blood pressure monitoring	at 9 months
Body composition	Assessment of whole body and abdominal fat mass, and total fat-free mass using DXA.	at 9 months

Collaborators and Investigators

• Sponsor: University Hospital, Geneva
• Collaborators: Swiss National Science Foundation
• Investigators: Principal Investigator: Farpour-Lambert Nathalie, PD, University Hospital, Geneva

Publications and helpful links

General Publications

• 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.

Study record dates

Study Major Dates

• Study Start: September 1, 2001
• Primary Completion (Actual): December 1, 2008
• Study Completion (Actual): June 1, 2009

Study Registration Dates

• First Submitted: May 4, 2010
• First Submitted That Met QC Criteria: October 13, 2010
• First Posted (Estimate): October 14, 2010

Study Record Updates

• Last Update Posted (Estimate): October 14, 2010
• Last Update Submitted That Met QC Criteria: October 13, 2010
• Last Verified: October 1, 2010

More Information

Terms related to this study

• Keywords: Type 1 Diabetes, Bone mineral density, Growth; Cardiovascular diseases, Exercise, Training,; Child, Adolescent
• Additional Relevant MeSH Terms: Glucose Metabolism Disorders; Metabolic Diseases; Immune System Diseases; Autoimmune Diseases; Endocrine System Diseases; Diabetes Mellitus; Diabetes Mellitus, Type 1
• Other Study ID Numbers: snf n°63164

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No