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

May 4, 2010
October 13, 2010
September 2001
December 2008   (final data collection date for primary outcome measure)
  • 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.
Same as current
Complete list of historical versions of study NCT01220479 on ClinicalTrials.gov Archive Site
  • 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.
Same as current
Not Provided
Not Provided
 
Exercise Training Intervention in Children With Type 1 Diabetes
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.

Not Provided
Interventional
Not Provided
Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Single Blind (Outcomes Assessor)
Primary Purpose: Treatment
Type 1 Diabetes Mellitus
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 Healthy
    Intervention: Behavioral: Exercise training program
  • No Intervention: Control Diabetic
    Intervention: Behavioral: Exercise training program
  • Experimental: Exercise Diabetic
    Intervention: Behavioral: Exercise training program
  • Experimental: Exercise Healthy
    Intervention: Behavioral: Exercise training program
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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
59
June 2009
December 2008   (final data collection date for primary outcome measure)

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.
Both
8 Years to 16 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Switzerland
 
NCT01220479
snf n°63164
No
Farpour-Lambert Nathalie, University Hospital of Geneva
University Hospital, Geneva
Swiss National Science Foundation
Principal Investigator: Farpour-Lambert Nathalie, PD University Hospital, Geneva
University Hospital, Geneva
October 2010

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP