Perception of Blood Sugar Variations During Physical Activity in Healthy Subjects and Type 1 Diabetes Patients (GLYSPORT)

May 17, 2022 updated by: Université de Reims Champagne-Ardenne

Type 1 diabetes is an autoimmune disease with absence of insulin secretion. Blood sugar is a physiological variable that reflets for blood glucose concentration. Blood sugar level fluctuates, especially during physical activity.

Sports activity would increase insulin sensitivity, improve lifestyle and, by extension, promote glycemic balance. However, glycemic balance will be disturbed by physical activity with higher risk of hypoglycemia and hyperglycemia.

Moreover, hypoglycemia and hyperglycemia will impact body functions. Perceptions of blood sugar variations during physical exercise and their influences on sports performance have not been studied, whether in type 1 diabetes patients or healthy subjects.

Study Overview

Status

Not yet recruiting

Conditions

Intervention / Treatment

Detailed Description

The aim of the study is to evaluate the perception of blood sugar variations in healthy subjects and type 1 diabetes patients during physical activity

Study Type

Interventional

Enrollment (Anticipated)

30

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 Contact

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

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

  • Type 1 diabetics diagnosed more than 3 years ago and controlled (an HbA1c of less than 8%) for "type 1 diabetes" group
  • without diabetes for "healkthy" group
  • Male
  • Aged 18 to 65
  • Body Mass Index less than 30 kg/m2
  • regular running (at least 30 minutes per week and at least one 10-km run per year for the previous 2 years)
  • Agreeing to participate in the study

Exclusion Criteria:

  • Physical injury
  • beta blockers treatment

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: Basic Science
  • Allocation: Non-Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: "Type 1 diabetes" group
"type 1 diabetes" group: patients with type 1 diabetes
Other: Physical activity
Physical activity: 10 km run on a treadmill
Active Comparator: "healthy" group
"healthy" group : subjects without type 1 diabetes
Other: Physical activity
Physical activity: 10 km run on a treadmill

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
blood sugar
Time Frame: Day 0
Blood sugar evaluated in g/L via continuous blood glucose measurement
Day 0
Feeling lucidity
Time Frame: Day 0
Lucidity, which is a symptom of hyperglycaemia and hypoglycaemia, assessed by visual analog scale (between "not at all lucid" to "completely lucid"
Day 0
Feeling fatigue
Time Frame: Day 0
hydratation, which is a symptom of hyperglycaemia and hypoglycaemia, assessed by visual analog scale (between "no feeling of dehydration" to "dehydrated"
Day 0
feeling hungry
Time Frame: Day 0
hungry, which is a symptom of hyperglycaemia and hypoglycaemia, assessed by visual analog scale (between "no feeling of hunger" to "hungry"
Day 0
average speed per kilometer Sports performance
Time Frame: Day 0
Sports performance evaluated by average speed per kilometer of the 10 km run on a treadmill
Day 0
total running time
Time Frame: Day 0
Sports performance evaluated by total running time of the 10 km run on a treadmill
Day 0
average running speed
Time Frame: Day 0
Sports performance evaluated by average running speed of the 10 km run on a treadmill
Day 0

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Université de Reims Champagne-Ardenne

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 (Anticipated)

June 1, 2022

Primary Completion (Anticipated)

November 1, 2022

Study Completion (Anticipated)

February 1, 2023

Study Registration Dates

First Submitted

March 21, 2022

First Submitted That Met QC Criteria

April 26, 2022

First Posted (Actual)

May 3, 2022

Study Record Updates

Last Update Posted (Actual)

May 18, 2022

Last Update Submitted That Met QC Criteria

May 17, 2022

Last Verified

May 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 2022-RIPH_002_GLYSPORT

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

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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