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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)

Primary Purpose

Type 1 Diabetes

Status
Unknown status
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
controlled physical activity
Sponsored by
University Hospital, Clermont-Ferrand
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for Type 1 Diabetes focused on measuring Type 1 diabetes, Control, Physical activity, Substrate utilization, Hormonal regulation

Eligibility Criteria

6 Years - 12 Years (Child)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • CHU Clermont-FerrandRecruiting

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

type 1 diabetes

without type 1 diabetes

Arm Description

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 :

Outcomes

Primary Outcome Measures

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)

Secondary Outcome Measures

hormonal regulation of blood glucose
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)
lipoxmax : the intensity for wich lipid oxydation is maximum will be carried out by indirect calorimetry
during exercise
Comparison between infants during 10 days before and 4 days after exercise of blood glucose modification
Comparison of curves of interstitial blood glucose measured with Freestyle®

Full Information

First Posted
April 7, 2017
Last Updated
February 1, 2019
Sponsor
University Hospital, Clermont-Ferrand
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1. Study Identification

Unique Protocol Identification Number
NCT03139864
Brief Title
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.
Acronym
DIABSPORT
Official Title
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.
Study Type
Interventional

2. Study Status

Record Verification Date
February 2019
Overall Recruitment Status
Unknown status
Study Start Date
April 4, 2017 (Actual)
Primary Completion Date
May 2019 (Anticipated)
Study Completion Date
December 2019 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital, Clermont-Ferrand

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 1 Diabetes
Keywords
Type 1 diabetes, Control, Physical activity, Substrate utilization, Hormonal regulation

7. Study Design

Primary Purpose
Prevention
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Masking Description
no masking is used. All involved know the identity of the intervention assignment
Allocation
Non-Randomized
Enrollment
48 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
type 1 diabetes
Arm Type
Experimental
Arm Description
Comparison between infants with type 1 diabetes and infants without type 1 diabetes during exercise :
Arm Title
without type 1 diabetes
Arm Type
Active Comparator
Arm Description
Comparison between infants with type 1 diabetes and infants without type 1 diabetes during exercise :
Intervention Type
Procedure
Intervention Name(s)
controlled physical activity
Intervention Description
Comparison between infants with type 1 diabetes and infants without type 1 diabetes during exercise :
Primary Outcome Measure Information:
Title
Comparison of substrate utilization between infants with type 1 diabetes and infants without type 1 diabetes during exercise
Description
Measurements will be carried out by indirect calorimetry and the relationship between CO2 et O2 (Metamax)
Time Frame
at day 1
Secondary Outcome Measure Information:
Title
hormonal regulation of blood glucose
Description
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)
Time Frame
at day 1
Title
lipoxmax : the intensity for wich lipid oxydation is maximum will be carried out by indirect calorimetry
Description
during exercise
Time Frame
at day 1
Title
Comparison between infants during 10 days before and 4 days after exercise of blood glucose modification
Description
Comparison of curves of interstitial blood glucose measured with Freestyle®
Time Frame
10 days before and 4 days after exercise of blood glucose modification

10. Eligibility

Sex
All
Minimum Age & Unit of Time
6 Years
Maximum Age & Unit of Time
12 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Patrick LACARIN
Phone
04 73 75 11 95
Email
placarin@chu-clermontferrand.fr
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Daniel TERRAL
Organizational Affiliation
University Hospital, Clermont-Ferrand
Official's Role
Principal Investigator
Facility Information:
Facility Name
CHU Clermont-Ferrand
City
Clermont-Ferrand
ZIP/Postal Code
63003
Country
France
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Patrick LACARIN
Phone
04 73 75 11 95
Email
placarin@chu-clermontferrand.fr
First Name & Middle Initial & Last Name & Degree
Daniel TERRAL

12. IPD Sharing Statement

Learn more about this trial

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.

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