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

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

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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