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

Type 1 Diabetes Clinical Trial

— GLYSPORT  

Official title:

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

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT05357534
• Other study ID #: 2022-RIPH_002_GLYSPORT
• Status: Not yet recruiting
• Phase: N/A
• Start date: June 1, 2022
• Est. completion date: February 1, 2023

Study information

• Verified date: May 2022
• Source: Université de Reims Champagne-Ardenne
• Contact: Philippe JOLY, MCU-HDR
• Phone: 0326918822
• Email: philippe.joly[@]univ-reims.fr
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 30
• Est. completion date: February 1, 2023
• Est. primary completion date: November 1, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Male
• Age group: 18 Years to 65 Years

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Other:
• Physical activity
Physical activity: 10 km run on a treadmill

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Université de Reims Champagne-Ardenne

Outcome

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