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

Primary Purpose

Type 1 Diabetes Mellitus

Status
Completed
Phase
Not Applicable
Locations
Switzerland
Study Type
Interventional
Intervention
Exercise training program
Sponsored by
University Hospital, Geneva
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 1 Diabetes Mellitus focused on measuring Type 1 Diabetes, Bone mineral density, Growth, Cardiovascular diseases, Exercise, Training,, Child, Adolescent

Eligibility Criteria

8 Years - 16 Years (Child)All SexesAccepts Healthy Volunteers

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: 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.

Sites / Locations

  • University Hospital of Geneva

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

No Intervention

No Intervention

Experimental

Experimental

Arm Label

Control Healthy

Control Diabetic

Exercise Diabetic

Exercise Healthy

Arm Description

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
May 4, 2010
Last Updated
October 13, 2010
Sponsor
University Hospital, Geneva
Collaborators
Swiss National Science Foundation
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1. Study Identification

Unique Protocol Identification Number
NCT01220479
Brief Title
Exercise Training Intervention in Children With Type 1 Diabetes
Acronym
Diabex
Official Title
Impact of an Exercise Training Program on Bone Development and Cardiovascular Disease Risk Factors in Children With Type 1 Diabetes Mellitus
Study Type
Interventional

2. Study Status

Record Verification Date
October 2010
Overall Recruitment Status
Completed
Study Start Date
September 2001 (undefined)
Primary Completion Date
December 2008 (Actual)
Study Completion Date
June 2009 (Actual)

3. Sponsor/Collaborators

Name of the Sponsor
University Hospital, Geneva
Collaborators
Swiss National Science Foundation

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes Mellitus
Keywords
Type 1 Diabetes, Bone mineral density, Growth, Cardiovascular diseases, Exercise, Training,, Child, Adolescent

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Outcomes Assessor
Allocation
Randomized
Enrollment
59 (Actual)

8. Arms, Groups, and Interventions

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

10. Eligibility

Sex
All
Minimum Age & Unit of Time
8 Years
Maximum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Farpour-Lambert Nathalie, PD
Organizational Affiliation
University Hospital, Geneva
Official's Role
Principal Investigator
Facility Information:
Facility Name
University Hospital of Geneva
City
Geneva
ZIP/Postal Code
1205
Country
Switzerland

12. IPD Sharing Statement

Citations:
PubMed Identifier
22246217
Citation
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.
Results Reference
derived

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Exercise Training Intervention in Children With Type 1 Diabetes

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