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Trial record 1 of 3246 for:    Type 1 Diabetes
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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)

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ClinicalTrials.gov Identifier: NCT03139864
Recruitment Status : Not yet recruiting
First Posted : May 4, 2017
Last Update Posted : May 8, 2017
Sponsor:
Information provided by (Responsible Party):
University Hospital, Clermont-Ferrand

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.

Condition or disease Intervention/treatment Phase
Type 1 Diabetes Procedure: controlled physical activity Not Applicable

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  (Clinical Trial)
Estimated Enrollment : 48 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Masking Description: no masking is used. All involved know the identity of the intervention assignment
Primary Purpose: Prevention
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.
Estimated Study Start Date : May 2017
Estimated Primary Completion Date : May 2018
Estimated Study Completion Date : December 2018

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: type 1 diabetes
Comparison between infants with type 1 diabetes and infants without type 1 diabetes during exercise :
Procedure: controlled physical activity
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 :
Procedure: controlled physical activity
Comparison between infants with type 1 diabetes and infants without type 1 diabetes during exercise :




Primary Outcome Measures :
  1. 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)


Secondary Outcome Measures :
  1. 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)

  2. lipoxmax : the intensity for wich lipid oxydation is maximum will be carried out by indirect calorimetry [ Time Frame: at day 1 ]
    during exercise

  3. 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®



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Ages Eligible for Study:   6 Years to 12 Years   (Child)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03139864


Contacts
Contact: Patrick LACARIN 04 73 75 11 95 placarin@chu-clermontferrand.fr

Locations
France
CHU Clermont-Ferrand Not yet recruiting
Clermont-Ferrand, France, 63003
Contact: Patrick LACARIN    04 73 75 11 95    placarin@chu-clermontferrand.fr   
Principal Investigator: Daniel TERRAL         
Sponsors and Collaborators
University Hospital, Clermont-Ferrand
Investigators
Principal Investigator: Daniel TERRAL University Hospital, Clermont-Ferrand

Responsible Party: University Hospital, Clermont-Ferrand
ClinicalTrials.gov Identifier: NCT03139864     History of Changes
Other Study ID Numbers: CHU-0292
2016-A01837-44 ( Other Identifier: 2016-A01837-44 )
First Posted: May 4, 2017    Key Record Dates
Last Update Posted: May 8, 2017
Last Verified: May 2017

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

Keywords provided by University Hospital, Clermont-Ferrand:
Type 1 diabetes
Control
Physical activity
Substrate utilization
Hormonal regulation

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 1
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Autoimmune Diseases
Immune System Diseases