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
2 other identifiers
interventional
48
1 country
1
Brief Summary
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for not_applicable
Started Apr 2017
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
April 4, 2017
CompletedFirst Submitted
Initial submission to the registry
April 7, 2017
CompletedFirst Posted
Study publicly available on registry
May 4, 2017
CompletedPrimary Completion
Last participant's last visit for primary outcome
May 1, 2019
CompletedStudy Completion
Last participant's last visit for all outcomes
December 1, 2019
CompletedFebruary 4, 2019
February 1, 2019
2.1 years
April 7, 2017
February 1, 2019
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Comparison of substrate utilization between infants with type 1 diabetes and infants without type 1 diabetes during exercise
Measurements will be carried out by indirect calorimetry and the relationship between CO2 et O2 (Metamax)
at day 1
Secondary Outcomes (3)
hormonal regulation of blood glucose
at day 1
lipoxmax : the intensity for wich lipid oxydation is maximum will be carried out by indirect calorimetry
at day 1
Comparison between infants during 10 days before and 4 days after exercise of blood glucose modification
10 days before and 4 days after exercise of blood glucose modification
Study Arms (2)
type 1 diabetes
EXPERIMENTALComparison between infants with type 1 diabetes and infants without type 1 diabetes during exercise :
without type 1 diabetes
ACTIVE COMPARATORComparison between infants with type 1 diabetes and infants without type 1 diabetes during exercise :
Interventions
Comparison between infants with type 1 diabetes and infants without type 1 diabetes during exercise :
Eligibility Criteria
You may qualify if:
- Children between 6 and 12 years
- Tanner stage \<T2
- Type 1 diabetes for more than 1 year for infants with type 1 diabetes
You may not qualify if:
- Tanner stage \> ou = T2
- Obesity
- Hormonal disease
- Disease who prevent doing exercise
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
CHU Clermont-Ferrand
Clermont-Ferrand, 63003, France
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Daniel TERRAL
University Hospital, Clermont-Ferrand
Central Study Contacts
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Masking Details
- no masking is used. All involved know the identity of the intervention assignment
- Purpose
- PREVENTION
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
April 7, 2017
First Posted
May 4, 2017
Study Start
April 4, 2017
Primary Completion
May 1, 2019
Study Completion
December 1, 2019
Last Updated
February 4, 2019
Record last verified: 2019-02