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.

NCT ID: NCT03139864

Last Updated: 2019-02-04

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

48 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-04-04

Study Completion Date

2019-12-31

Brief Summary

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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

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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.

Conditions

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Type 1 Diabetes

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

NONE

no masking is used. All involved know the identity of the intervention assignment

Study Groups

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type 1 diabetes

Comparison between infants with type 1 diabetes and infants without type 1 diabetes during exercise :

Group Type EXPERIMENTAL

controlled physical activity

Intervention Type PROCEDURE

Comparison between infants with type 1 diabetes and infants without type 1 diabetes during exercise :

without type 1 diabetes

Comparison between infants with type 1 diabetes and infants without type 1 diabetes during exercise :

Group Type ACTIVE_COMPARATOR

controlled physical activity

Intervention Type PROCEDURE

Comparison between infants with type 1 diabetes and infants without type 1 diabetes during exercise :

Interventions

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controlled physical activity

Comparison between infants with type 1 diabetes and infants without type 1 diabetes during exercise :

Intervention Type PROCEDURE

Eligibility Criteria

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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
Minimum Eligible Age

6 Years

Maximum Eligible Age

12 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University Hospital, Clermont-Ferrand

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Daniel TERRAL

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Clermont-Ferrand

Locations

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CHU Clermont-Ferrand

Clermont-Ferrand, , France

Site Status RECRUITING

Countries

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France

Central Contacts

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Patrick LACARIN

Role: CONTACT

04 73 75 11 95

Facility Contacts

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Patrick LACARIN

Role: primary

04 73 75 11 95

Other Identifiers

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2016-A01837-44

Identifier Type: OTHER

Identifier Source: secondary_id

CHU-0292

Identifier Type: -

Identifier Source: org_study_id

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