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.

Type 1 Diabetes Clinical Trial

— 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.

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03139864
• Other study ID #: CHU-0292
• Secondary ID: 2016-A01837-44
• Status: Recruiting
• Phase: N/A
• Start date: April 4, 2017
• Est. completion date: December 2019

Study information

• Verified date: February 2019
• Source: University Hospital, Clermont-Ferrand
• Contact: Patrick LACARIN
• Phone: 04 73 75 11 95
• Email: placarin[@]chu-clermontferrand.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 48
• Est. completion date: December 2019
• Est. primary completion date: May 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 6 Years to 12 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 1
• Type 1 Diabetes

Intervention

Procedure:
• controlled physical activity
Comparison between infants with type 1 diabetes and infants without type 1 diabetes during exercise :

Locations

Country	Name	City	State
France	CHU Clermont-Ferrand	Clermont-Ferrand

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Clermont-Ferrand

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	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)	at day 1
Secondary	lipoxmax : the intensity for wich lipid oxydation is maximum will be carried out by indirect calorimetry	during exercise	at day 1
Secondary	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®	10 days before and 4 days after exercise of blood glucose modification