- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03139864
Comparison of the Use of Energy Substrates and Hormonal Regulation of Blood Sugar During Exercise of Increasing Intensity Between Children With Type 1 Diabetes and Non-diabetic Control Children. (DIABSPORT)
February 1, 2019 updated by: University Hospital, Clermont-Ferrand
The type 1 diabetes is a common chronic disease characterised by the stop of production of insulin by the pancreas.
A lot of factors modify blood glucose.
The objective is to study the effect of type 1 diabetes on the use of energy substrates (fats and carbohydrates) during exercise of increasing intensity by a comparison with non-diabetic controls children.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
Detailed Description
The type 1 diabetes is a common chronic disease characterised by the stop of production of insulin by the pancreas.
A lot of factors modify blood glucose.
The objective is to study the effect of type 1 diabetes on the use of energy substrates (fats and carbohydrates) during exercise of increasing intensity by a comparison with non-diabetic controls children.
Study Type
Interventional
Enrollment (Anticipated)
48
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Locations
-
-
-
Clermont-Ferrand, France, 63003
- Recruiting
- CHU Clermont-Ferrand
-
Principal Investigator:
- Daniel TERRAL
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
6 years to 12 years (Child)
Accepts Healthy Volunteers
Yes
Genders Eligible for Study
All
Description
Inclusion Criteria:
- Children between 6 and 12 years
- Tanner stage <T2
- Type 1 diabetes for more than 1 year for infants with type 1 diabetes
Exclusion Criteria:
- Tanner stage > ou = T2
- Obesity
- Hormonal disease
- Disease who prevent doing exercise
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Non-Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: type 1 diabetes
Comparison between infants with type 1 diabetes and infants without type 1 diabetes during exercise :
|
Comparison between infants with type 1 diabetes and infants without type 1 diabetes during exercise :
|
Active Comparator: without type 1 diabetes
Comparison between infants with type 1 diabetes and infants without type 1 diabetes during exercise :
|
Comparison between infants with type 1 diabetes and infants without type 1 diabetes during exercise :
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Comparison of substrate utilization between infants with type 1 diabetes and infants without type 1 diabetes during exercise
Time Frame: at day 1
|
Measurements will be carried out by indirect calorimetry and the relationship between CO2 et O2 (Metamax)
|
at day 1
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
hormonal regulation of blood glucose
Time Frame: at day 1
|
insulin, glucagon, adrenaline, cortisol and growth hormone will be metered according to their half life until 2 hours after physical activity (T12, T20, T40, T60, T120)
|
at day 1
|
lipoxmax : the intensity for wich lipid oxydation is maximum will be carried out by indirect calorimetry
Time Frame: at day 1
|
during exercise
|
at day 1
|
Comparison between infants during 10 days before and 4 days after exercise of blood glucose modification
Time Frame: 10 days before and 4 days after exercise of blood glucose modification
|
Comparison of curves of interstitial blood glucose measured with Freestyle®
|
10 days before and 4 days after exercise of blood glucose modification
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Principal Investigator: Daniel TERRAL, University Hospital, Clermont-Ferrand
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Actual)
April 4, 2017
Primary Completion (Anticipated)
May 1, 2019
Study Completion (Anticipated)
December 1, 2019
Study Registration Dates
First Submitted
April 7, 2017
First Submitted That Met QC Criteria
May 2, 2017
First Posted (Actual)
May 4, 2017
Study Record Updates
Last Update Posted (Actual)
February 4, 2019
Last Update Submitted That Met QC Criteria
February 1, 2019
Last Verified
February 1, 2019
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CHU-0292
- 2016-A01837-44 (Other Identifier: 2016-A01837-44)
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
No
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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