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

This study has been completed.
Sponsor:
Collaborator:
Swiss National Science Foundation
Information provided by:
University Hospital, Geneva
ClinicalTrials.gov Identifier:
NCT01220479
First received: May 4, 2010
Last updated: October 13, 2010
Last verified: October 2010
History of Changes
  Purpose

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.


Condition Intervention
Type 1 Diabetes Mellitus
 Behavioral: Exercise training program

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Impact of an Exercise Training Program on Bone Development and Cardiovascular Disease Risk Factors in Children With Type 1 Diabetes Mellitus

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Hospital, Geneva:

Primary Outcome Measures:
  • Bone mineral density and content [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Assessment of bone mineral density (BMD) and content (BMC) at the whole body, hip and lumbar spine using DXA.

  • Bone mineral density and content [ Time Frame: at 9 months ] [ Designated as safety issue: No ]
    Assessment of bone mineral density (BMD) and content (BMC) at the whole body, hip and lumbar spine using DXA.


Secondary Outcome Measures:
  • Anthropometrics [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Body weight, height, body mass index and pubertal stage

  • Blood lipids levels [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Fasting total cholesterol, LDL-Cholesterol, HDL-Cholesterol, triglycerides, lipoprotein (a), apolipoproteins A-I and B levels.

  • Physical activity [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Physical activity level by questionnaire and accelerometer

  • Nutrition [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Total energy, proteins, lipids, carbohydrates and calcium intakes using food records

  • Circulating bone biomarkers levels [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    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 [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    capillary HbA1c levels

  • Systemic blood pressure [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Resting and 24-hour ambulatory systemic blood pressure monitoring

  • Body composition [ Time Frame: Baseline ] [ Designated as safety issue: No ]
    Assessment of whole body and abdominal fat mass, and total fat-free mass using DXA.

  • Anthropometrics [ Time Frame: at 9 months ] [ Designated as safety issue: No ]
    Body weight, height, body mass index and pubertal stage

  • Blood lipids levels [ Time Frame: at 9 months ] [ Designated as safety issue: No ]
    Fasting total cholesterol, LDL-Cholesterol, HDL-Cholesterol, triglycerides, lipoprotein (a), apolipoproteins A-I and B levels.

  • Physical activity [ Time Frame: at 9 months ] [ Designated as safety issue: No ]
    Physical activity level by questionnaire and accelerometer

  • Nutrition [ Time Frame: at 9 months ] [ Designated as safety issue: No ]
    Total energy, proteins, lipids, carbohydrates and calcium intakes using food records

  • Circulating bone biomarkers levels [ Time Frame: at 9 months ] [ Designated as safety issue: No ]
    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 [ Time Frame: at 3 months ] [ Designated as safety issue: No ]
    capillary HbA1c levels

  • Glycated Haemoglobin [ Time Frame: at 6 months ] [ Designated as safety issue: No ]
    capillary HbA1c levels

  • Glycated Haemoglobin [ Time Frame: at 9 months ] [ Designated as safety issue: No ]
    capillary HbA1c levels

  • Systemic blood pressure [ Time Frame: at 9 months ] [ Designated as safety issue: No ]
    Resting and 24-hour ambulatory systemic blood pressure monitoring

  • Body composition [ Time Frame: at 9 months ] [ Designated as safety issue: No ]
    Assessment of whole body and abdominal fat mass, and total fat-free mass using DXA.


Enrollment: 59
Study Start Date: September 2001
Study Completion Date: June 2009
Primary Completion Date: December 2008 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
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.

  Eligibility

Ages Eligible for Study:   8 Years to 16 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01220479

Locations
Switzerland
University Hospital of Geneva
Geneva, Switzerland, 1205
Sponsors and Collaborators
University Hospital, Geneva
Swiss National Science Foundation
Investigators
Principal Investigator: Farpour-Lambert Nathalie, PD University Hospital, Geneva
  More Information

No publications provided by University Hospital, Geneva

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):

Responsible Party: Farpour-Lambert Nathalie, University Hospital of Geneva
ClinicalTrials.gov Identifier: NCT01220479     History of Changes
Other Study ID Numbers: snf n°63164
Study First Received: May 4, 2010
Last Updated: October 13, 2010
Health Authority: Switzerland: Ethikkommission

Keywords provided by University Hospital, Geneva:
Type 1 Diabetes, Bone mineral density, Growth
Cardiovascular diseases, Exercise, Training,
Child, Adolescent

Additional relevant MeSH terms:
Cardiovascular Diseases
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
 Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases

ClinicalTrials.gov processed this record on May 23, 2013