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
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
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
NCT ID
NCT05357534
First Posted
March 21, 2022
Last Updated
May 17, 2022
Sponsor
Université de Reims Champagne-Ardenne
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
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Perception of Blood Sugar Variations During Physical Activity in Healthy Subjects and Type 1 Diabetes Patients
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