Exercise Training Intervention in Children With Type 1 Diabetes

NCT01220479 | Completed

• 1 other identifier: snf n°63164
• Study Type: interventional
• Target: 59
• Locations: 1 country
• Sites: 1

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.

Conditions

Type 1 Diabetes Mellitus

Keywords

Type 1 Diabetes, Bone mineral density, Growth; Cardiovascular diseases, Exercise, Training,; Child, Adolescent

Outcome Measures

Primary Outcomes (2)

• 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 Outcomes (18)

• Anthropometrics

  Baseline

• Blood lipids levels

  Baseline

• Physical activity

  Baseline

• Nutrition

  Baseline

• Circulating bone biomarkers levels

  Baseline

Study Arms (4)

Control Healthy

NO INTERVENTION

Behavioral: Exercise training program

Control Diabetic

NO INTERVENTION

Behavioral: Exercise training program

Exercise Diabetic

EXPERIMENTAL

Behavioral: Exercise training program

Exercise Healthy

EXPERIMENTAL

Behavioral: Exercise training program

Interventions

Exercise training program BEHAVIORAL

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.

Control Diabetic; Control Healthy; Exercise Diabetic; Exercise Healthy

Eligibility Criteria

• Age: 8 Years - 16 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17)

You may qualify if:

• \) disease for at least 1 year.
• \) good general health and normal growth.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University Hospital, Geneva: lead
• Swiss National Science Foundation: collaborator

Study Sites (1)

University Hospital of Geneva

Geneva, Canton of Geneva, 1205, Switzerland

Location

Related Publications (1)

• 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.

  PMID: 22246217 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 1; Cardiovascular Diseases; Motor Activity

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Autoimmune Diseases; Immune System Diseases; Behavior

Study Officials

• Farpour-Lambert Nathalie, PD

  University Hospital, Geneva

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER

Study Record Dates

• First Submitted: May 4, 2010
• First Posted: October 14, 2010
• Study Start: September 1, 2001
• Primary Completion: December 1, 2008
• Study Completion: June 1, 2009
• Last Updated: October 14, 2010

Record last verified: 2010-10

Locations

CH (1)