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

Primary Purpose

Type 1 Diabetes

Status
Not yet recruiting
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Physical activity
Sponsored by
Université de Reims Champagne-Ardenne
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Type 1 Diabetes focused on measuring Type 1 Diabetes, blood sugar variations, physical activity

Eligibility Criteria

18 Years - 65 Years (Adult, Older Adult)MaleAccepts Healthy Volunteers

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

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Experimental

    Active Comparator

    Arm Label

    "Type 1 diabetes" group

    "healthy" group

    Arm Description

    "type 1 diabetes" group: patients with type 1 diabetes

    "healthy" group : subjects without type 1 diabetes

    Outcomes

    Primary Outcome Measures

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

    Secondary Outcome Measures

    Full Information

    First Posted
    March 21, 2022
    Last Updated
    May 17, 2022
    Sponsor
    Université de Reims Champagne-Ardenne
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    1. Study Identification

    Unique Protocol Identification Number
    NCT05357534
    Brief Title
    Perception of Blood Sugar Variations During Physical Activity in Healthy Subjects and Type 1 Diabetes Patients
    Acronym
    GLYSPORT
    Official Title
    Perception of Blood Sugar Variations During Physical Activity in Healthy Subjects and Type 1 Diabetes Patients
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    May 2022
    Overall Recruitment Status
    Not yet recruiting
    Study Start Date
    June 1, 2022 (Anticipated)
    Primary Completion Date
    November 1, 2022 (Anticipated)
    Study Completion Date
    February 1, 2023 (Anticipated)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    Université de Reims Champagne-Ardenne

    4. Oversight

    Studies a U.S. FDA-regulated Drug Product
    No
    Studies a U.S. FDA-regulated Device Product
    No
    Data Monitoring Committee
    No

    5. Study Description

    Brief Summary
    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.
    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

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Type 1 Diabetes
    Keywords
    Type 1 Diabetes, blood sugar variations, physical activity

    7. Study Design

    Primary Purpose
    Basic Science
    Study Phase
    Not Applicable
    Interventional Study Model
    Parallel Assignment
    Masking
    None (Open Label)
    Allocation
    Non-Randomized
    Enrollment
    30 (Anticipated)

    8. Arms, Groups, and Interventions

    Arm Title
    "Type 1 diabetes" group
    Arm Type
    Experimental
    Arm Description
    "type 1 diabetes" group: patients with type 1 diabetes
    Arm Title
    "healthy" group
    Arm Type
    Active Comparator
    Arm Description
    "healthy" group : subjects without type 1 diabetes
    Intervention Type
    Other
    Intervention Name(s)
    Physical activity
    Intervention Description
    Physical activity: 10 km run on a treadmill
    Primary Outcome Measure Information:
    Title
    blood sugar
    Description
    Blood sugar evaluated in g/L via continuous blood glucose measurement
    Time Frame
    Day 0
    Title
    Feeling lucidity
    Description
    Lucidity, which is a symptom of hyperglycaemia and hypoglycaemia, assessed by visual analog scale (between "not at all lucid" to "completely lucid"
    Time Frame
    Day 0
    Title
    Feeling fatigue
    Description
    hydratation, which is a symptom of hyperglycaemia and hypoglycaemia, assessed by visual analog scale (between "no feeling of dehydration" to "dehydrated"
    Time Frame
    Day 0
    Title
    feeling hungry
    Description
    hungry, which is a symptom of hyperglycaemia and hypoglycaemia, assessed by visual analog scale (between "no feeling of hunger" to "hungry"
    Time Frame
    Day 0
    Title
    average speed per kilometer Sports performance
    Description
    Sports performance evaluated by average speed per kilometer of the 10 km run on a treadmill
    Time Frame
    Day 0
    Title
    total running time
    Description
    Sports performance evaluated by total running time of the 10 km run on a treadmill
    Time Frame
    Day 0
    Title
    average running speed
    Description
    Sports performance evaluated by average running speed of the 10 km run on a treadmill
    Time Frame
    Day 0

    10. Eligibility

    Sex
    Male
    Gender Based
    Yes
    Gender Eligibility Description
    Male
    Minimum Age & Unit of Time
    18 Years
    Maximum Age & Unit of Time
    65 Years
    Accepts Healthy Volunteers
    Accepts Healthy Volunteers
    Eligibility Criteria
    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
    Central Contact Person:
    First Name & Middle Initial & Last Name or Official Title & Degree
    Philippe JOLY, MCU-HDR
    Phone
    0326918822
    Ext
    +33
    Email
    philippe.joly@univ-reims.fr
    First Name & Middle Initial & Last Name or Official Title & Degree
    Coralie BARBE, MD
    Phone
    0326918822
    Ext
    +33
    Email
    currs@univ-reims.fr

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

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

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