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Type 1 Diabetes MellitusDiabexNCT01220479

Exercise Training Intervention in Children With Type 1 Diabetes

A study testing Exercise training program in people with Type 1 Diabetes Mellitus, run by University Hospital, Geneva at 1 site in Switzerland.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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. Read more about this study

Who is it for?
Ages 8 to 16 yearsHealthy volunteers can take part
Conditions the study is for
Type 1 Diabetes Mellitus
What is being tested?
Exercise training program
Could I receive a placebo?
No, everyone receives an active treatment
How many people
59 participants
Where
1 siteSwitzerland
Study dates
Sep 2001to Jun 2009
Phase
Interventional
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 8 to 16 years
  • All sexes
  • Healthy volunteers accepted
  • Child

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.

Trial locations and contacts

1 site in 1 country.

Switzerland1 site

  • University Hospital of Geneva

    Geneva, Canton of Geneva, 1205

Other trials in Switzerland

About this study

Official title: 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.

Read more

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.

Being tested
Exercise training program
Keywords
Type 1 Diabetes, Bone mineral density, Growth, Cardiovascular diseases, Exercise, Training,, Child, Adolescent
Medical subject headings
Diabetes Mellitus, Type 1, Cardiovascular Diseases, Motor Activity

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Exercise training programBehavioural

    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.

Study groups in NCT01220479
Study groupRoleWhat they receive
Control HealthyNo interventionNot described
Receives: Behavioral: Exercise training program
Control DiabeticNo interventionNot described
Receives: Behavioral: Exercise training program
Exercise DiabeticExperimentalNot described
Receives: Behavioral: Exercise training program
Exercise HealthyExperimentalNot described
Receives: Behavioral: Exercise training program

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Bone mineral density and content

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

    Measured: Baseline

  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.

    Measured: at 9 months

Secondary outcomes (18)

  1. Anthropometrics

    Body weight, height, body mass index and pubertal stage

    Measured: Baseline

  2. Blood lipids levels

    Fasting total cholesterol, LDL-Cholesterol, HDL-Cholesterol, triglycerides, lipoprotein (a), apolipoproteins A-I and B levels.

    Measured: Baseline

  3. Physical activity

    Physical activity level by questionnaire and accelerometer

    Measured: Baseline

  4. Nutrition

    Total energy, proteins, lipids, carbohydrates and calcium intakes using food records

    Measured: Baseline

  5. 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)

    Measured: Baseline

  6. Glycated Haemoglobin

    capillary HbA1c levels

    Measured: Baseline

  7. Systemic blood pressure

    Resting and 24-hour ambulatory systemic blood pressure monitoring

    Measured: Baseline

  8. Body composition

    Assessment of whole body and abdominal fat mass, and total fat-free mass using DXA.

    Measured: Baseline

  9. Anthropometrics

    Body weight, height, body mass index and pubertal stage

    Measured: at 9 months

  10. Blood lipids levels

    Fasting total cholesterol, LDL-Cholesterol, HDL-Cholesterol, triglycerides, lipoprotein (a), apolipoproteins A-I and B levels.

    Measured: at 9 months

  11. Physical activity

    Physical activity level by questionnaire and accelerometer

    Measured: at 9 months

  12. Nutrition

    Total energy, proteins, lipids, carbohydrates and calcium intakes using food records

    Measured: at 9 months

  13. 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)

    Measured: at 9 months

  14. Glycated Haemoglobin

    capillary HbA1c levels

    Measured: at 3 months

  15. Glycated Haemoglobin

    capillary HbA1c levels

    Measured: at 6 months

  16. Glycated Haemoglobin

    capillary HbA1c levels

    Measured: at 9 months

  17. Systemic blood pressure

    Resting and 24-hour ambulatory systemic blood pressure monitoring

    Measured: at 9 months

  18. Body composition

    Assessment of whole body and abdominal fat mass, and total fat-free mass using DXA.

    Measured: at 9 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted14 Oct 2010 (estimated)
  2. Study startSep 2001
  3. Primary completionDec 2008
  4. Study completionJun 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Masking
Single blind
Who is masked
Outcomes assessor
Enrolment
59 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT01220479
Sponsor's protocol ID
snf n°63164
Acronym
Diabex
Status last verified
Oct 2010
First submitted
4 May 2010
Last updated
14 Oct 2010
Results posted
No
Data monitoring committee
No

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.

    PubMed 22246217

Questions about this trial

What is this clinical trial studying?

A study testing Exercise training program in people with Type 1 Diabetes Mellitus, run by University Hospital, Geneva at 1 site in Switzerland.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Oct 2010. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Bone mineral density and content (time frame: Baseline). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT01220479, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Oct 2010.

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