NCT05357534

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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
30

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Jun 2022

Shorter than P25 for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 21, 2022

Completed
1 month until next milestone

First Posted

Study publicly available on registry

May 3, 2022

Completed
29 days until next milestone

Study Start

First participant enrolled

June 1, 2022

Completed
5 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2022

Completed
3 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2023

Completed
Last Updated

May 18, 2022

Status Verified

May 1, 2022

Enrollment Period

5 months

First QC Date

March 21, 2022

Last Update Submit

May 17, 2022

Conditions

Type 1 Diabetes

Keywords

Type 1 Diabetesblood sugar variationsphysical activity

Outcome Measures

Primary Outcomes (7)

  • blood sugar

    Blood sugar evaluated in g/L via continuous blood glucose measurement

    Day 0

  • 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

  • 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

  • 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

  • average speed per kilometer Sports performance

    Sports performance evaluated by average speed per kilometer of the 10 km run on a treadmill

    Day 0

  • total running time

    Sports performance evaluated by total running time of the 10 km run on a treadmill

    Day 0

  • average running speed

    Sports performance evaluated by average running speed of the 10 km run on a treadmill

    Day 0

Study Arms (2)

"Type 1 diabetes" group

EXPERIMENTAL

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

Other: Physical activity

"healthy" group

ACTIVE COMPARATOR

"healthy" group : subjects without type 1 diabetes

Other: Physical activity

Interventions

Physical activityOTHER

Physical activity: 10 km run on a treadmill

"Type 1 diabetes" group"healthy" group

Eligibility Criteria

Age18 Years - 65 Years
Sexmale(Gender-based eligibility)
Gender Eligibility DetailsMale
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • Physical injury
  • beta blockers treatment

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Diabetes Mellitus, Type 1Motor Activity

Interventions

Exercise

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System DiseasesBehavior

Intervention Hierarchy (Ancestors)

Motor ActivityMovementMusculoskeletal Physiological PhenomenaMusculoskeletal and Neural Physiological Phenomena

Central Study Contacts

Philippe JOLY, MCU-HDR

CONTACT

0326918822philippe.joly@univ-reims.fr

Coralie BARBE, MD

CONTACT

0326918822currs@univ-reims.fr

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
BASIC SCIENCE
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 21, 2022

First Posted

May 3, 2022

Study Start

June 1, 2022

Primary Completion

November 1, 2022

Study Completion

February 1, 2023

Last Updated

May 18, 2022

Record last verified: 2022-05

Data Sharing

IPD Sharing
Will not share