High-intensity Interval Exercise Compared With Continuous Moderate Exercise on Glycemia in Postabsorptive vs. Postprandial State in Adults With Type 1 Diabetes (Interdiab 1)
The Protective Role of High-intensity Interval Exercise Compared With Continuous Moderate Exercise on Glycemia Decrease is More Relevant in Postabsorptive vs. Postprandial State in Adults With Type 1 Diabetes
Study Overview
Status
Status
Conditions
Conditions
Intervention / Treatment
Intervention / Treatment
- Other: High-intensity interval exercise performed in postprandial phase
- Other: High-intensity interval exercise performed in postabsorptive phase
- Other: Moderate-intensity continuous exercise performed in postprandial phase
- Other: Moderate-intensity continuous exercise performed in postabsorptive phase
Detailed Description
Study Type
Study Type
Enrollment (Actual)
Enrollment
Phase
Phase
- Not Applicable
Contacts and Locations
Study Locations
-
-
-
Loos, France, 59120
- Unité de Recherche Pluridisciplinaire Sport, Santé, Société (URePSSS - ULR 7369)
-
-
Participation Criteria
Eligibility Criteria
Eligibility Criteria
Ages Eligible for Study
- Adult
Accepts Healthy Volunteers
Description
Inclusion Criteria:
- Between 18 and 60 years of age
- Regular practice of physical activity (at least 2 training sessions/week for at least 3 months)
- Diagnosis of type 1 diabetes for >1 year
- No change in insulin delivery method (i.e., multiple daily injections [MDI], continuous subcutaneous insulin infusion [CSII] in open or closed loop) over the previous 3 months
- Use of a continuous glucose monitoring (CGM) device in daily life
Exclusion Criteria:
- Diabetes-related complications except for background retinopathy
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: Randomized
- Interventional Model: Crossover Assignment
- Masking: None (Open Label)
Number of Arms
Arms and Interventions
Participant Group / ArmParticipant Group / Arm |
Intervention / TreatmentIntervention / Treatment |
|---|---|
|
Experimental: A/B/C/D
A= High-intensity interval exercise in postabsorptive phase B= High-intensity interval exercise in postprandial phase C= Moderate-intensity continuous exercise in postabsorptive phase D= Moderate-intensity continuous exercise in postprandial phase
|
Exercises were performed on a cycle ergometer (Excalibur Sport, Lode B.V.).
Exercise began with a 3-min warm-up at 20% of maximum aerobic power (MAP) and ended with a 2-min active recovery at 20% of MAP.
The high-intensity interval exercise protocol consisted of ten 1-min intervals at 100% of MAP, each interspersed with 1-min of passive recovery.
For the postprandial state, exercise began 1.5 hours after the start of lunch and the corresponding meal-related bolus/rapid-acting insulin (i.e., in the early afternoon).
Exercises were performed on a cycle ergometer (Excalibur Sport, Lode B.V.).
Exercise began with a 3-min warm-up at 20% of maximum aerobic power (MAP) and ended with a 2-min active recovery at 20% of MAP.
The high-intensity interval exercise protocol consisted of ten 1-min intervals at 100% of MAP, each interspersed with 1-min of passive recovery.
For the postabsorptive state, exercise began 5 hours after the start of lunch (i.e., in the late afternoon).
Exercises were performed on a cycle ergometer (Excalibur Sport, Lode B.V.).
Exercise began with a 3-min warm-up at 20% of maximum aerobic power (MAP) and ended with a 2-min active recovery at 20% of MAP.
The moderate-intensity continuous exercise protocol consisted of continuous exercise at 50% of MAP for 20 minutes.
For the postprandial state, exercise began 1.5 hours after the start of lunch and the corresponding meal-related bolus/rapid-acting insulin (i.e., in the early afternoon).
Exercises were performed on a cycle ergometer (Excalibur Sport, Lode B.V.).
Exercise began with a 3-min warm-up at 20% of MAP and ended with a 2-min active recovery at 20% of maximum aerobic power (MAP).
The CONT protocol consisted of continuous exercise at 50% of MAP for 20 minutes.
For the postabsorptive state, exercise began 5 hours after the start of lunch (i.e., in the late afternoon).
|
|
Experimental: B/C/D/A
A= High-intensity interval exercise in postabsorptive phase B= High-intensity interval exercise in postprandial phase C= Moderate-intensity continuous exercise in postabsorptive phase D= Moderate-intensity continuous exercise in postprandial phase
|
Exercises were performed on a cycle ergometer (Excalibur Sport, Lode B.V.).
Exercise began with a 3-min warm-up at 20% of maximum aerobic power (MAP) and ended with a 2-min active recovery at 20% of MAP.
The high-intensity interval exercise protocol consisted of ten 1-min intervals at 100% of MAP, each interspersed with 1-min of passive recovery.
For the postprandial state, exercise began 1.5 hours after the start of lunch and the corresponding meal-related bolus/rapid-acting insulin (i.e., in the early afternoon).
Exercises were performed on a cycle ergometer (Excalibur Sport, Lode B.V.).
Exercise began with a 3-min warm-up at 20% of maximum aerobic power (MAP) and ended with a 2-min active recovery at 20% of MAP.
The high-intensity interval exercise protocol consisted of ten 1-min intervals at 100% of MAP, each interspersed with 1-min of passive recovery.
For the postabsorptive state, exercise began 5 hours after the start of lunch (i.e., in the late afternoon).
Exercises were performed on a cycle ergometer (Excalibur Sport, Lode B.V.).
Exercise began with a 3-min warm-up at 20% of maximum aerobic power (MAP) and ended with a 2-min active recovery at 20% of MAP.
The moderate-intensity continuous exercise protocol consisted of continuous exercise at 50% of MAP for 20 minutes.
For the postprandial state, exercise began 1.5 hours after the start of lunch and the corresponding meal-related bolus/rapid-acting insulin (i.e., in the early afternoon).
Exercises were performed on a cycle ergometer (Excalibur Sport, Lode B.V.).
Exercise began with a 3-min warm-up at 20% of MAP and ended with a 2-min active recovery at 20% of maximum aerobic power (MAP).
The CONT protocol consisted of continuous exercise at 50% of MAP for 20 minutes.
For the postabsorptive state, exercise began 5 hours after the start of lunch (i.e., in the late afternoon).
|
|
Experimental: C/D/A/B
A= High-intensity interval exercise in postabsorptive phase B= High-intensity interval exercise in postprandial phase C= Moderate-intensity continuous exercise in postabsorptive phase D= Moderate-intensity continuous exercise in postprandial phase
|
Exercises were performed on a cycle ergometer (Excalibur Sport, Lode B.V.).
Exercise began with a 3-min warm-up at 20% of maximum aerobic power (MAP) and ended with a 2-min active recovery at 20% of MAP.
The high-intensity interval exercise protocol consisted of ten 1-min intervals at 100% of MAP, each interspersed with 1-min of passive recovery.
For the postprandial state, exercise began 1.5 hours after the start of lunch and the corresponding meal-related bolus/rapid-acting insulin (i.e., in the early afternoon).
Exercises were performed on a cycle ergometer (Excalibur Sport, Lode B.V.).
Exercise began with a 3-min warm-up at 20% of maximum aerobic power (MAP) and ended with a 2-min active recovery at 20% of MAP.
The high-intensity interval exercise protocol consisted of ten 1-min intervals at 100% of MAP, each interspersed with 1-min of passive recovery.
For the postabsorptive state, exercise began 5 hours after the start of lunch (i.e., in the late afternoon).
Exercises were performed on a cycle ergometer (Excalibur Sport, Lode B.V.).
Exercise began with a 3-min warm-up at 20% of maximum aerobic power (MAP) and ended with a 2-min active recovery at 20% of MAP.
The moderate-intensity continuous exercise protocol consisted of continuous exercise at 50% of MAP for 20 minutes.
For the postprandial state, exercise began 1.5 hours after the start of lunch and the corresponding meal-related bolus/rapid-acting insulin (i.e., in the early afternoon).
Exercises were performed on a cycle ergometer (Excalibur Sport, Lode B.V.).
Exercise began with a 3-min warm-up at 20% of MAP and ended with a 2-min active recovery at 20% of maximum aerobic power (MAP).
The CONT protocol consisted of continuous exercise at 50% of MAP for 20 minutes.
For the postabsorptive state, exercise began 5 hours after the start of lunch (i.e., in the late afternoon).
|
|
Experimental: D/A/B/C
A= High-intensity interval exercise in postabsorptive phase B= High-intensity interval exercise in postprandial phase C= Moderate-intensity continuous exercise in postabsorptive phase D= Moderate-intensity continuous exercise in postprandial phase
|
Exercises were performed on a cycle ergometer (Excalibur Sport, Lode B.V.).
Exercise began with a 3-min warm-up at 20% of maximum aerobic power (MAP) and ended with a 2-min active recovery at 20% of MAP.
The high-intensity interval exercise protocol consisted of ten 1-min intervals at 100% of MAP, each interspersed with 1-min of passive recovery.
For the postprandial state, exercise began 1.5 hours after the start of lunch and the corresponding meal-related bolus/rapid-acting insulin (i.e., in the early afternoon).
Exercises were performed on a cycle ergometer (Excalibur Sport, Lode B.V.).
Exercise began with a 3-min warm-up at 20% of maximum aerobic power (MAP) and ended with a 2-min active recovery at 20% of MAP.
The high-intensity interval exercise protocol consisted of ten 1-min intervals at 100% of MAP, each interspersed with 1-min of passive recovery.
For the postabsorptive state, exercise began 5 hours after the start of lunch (i.e., in the late afternoon).
Exercises were performed on a cycle ergometer (Excalibur Sport, Lode B.V.).
Exercise began with a 3-min warm-up at 20% of maximum aerobic power (MAP) and ended with a 2-min active recovery at 20% of MAP.
The moderate-intensity continuous exercise protocol consisted of continuous exercise at 50% of MAP for 20 minutes.
For the postprandial state, exercise began 1.5 hours after the start of lunch and the corresponding meal-related bolus/rapid-acting insulin (i.e., in the early afternoon).
Exercises were performed on a cycle ergometer (Excalibur Sport, Lode B.V.).
Exercise began with a 3-min warm-up at 20% of MAP and ended with a 2-min active recovery at 20% of maximum aerobic power (MAP).
The CONT protocol consisted of continuous exercise at 50% of MAP for 20 minutes.
For the postabsorptive state, exercise began 5 hours after the start of lunch (i.e., in the late afternoon).
|
What is the study measuring?
Primary Outcome Measures
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Capillary glycemia
Time Frame: At rest before exercise, then at 10 and 20 min of exercise, at 2 min of active recovery post-exercise, and at 10 min of passive recovery post-exercise.
|
Blood glucose meter
|
At rest before exercise, then at 10 and 20 min of exercise, at 2 min of active recovery post-exercise, and at 10 min of passive recovery post-exercise.
|
Secondary Outcome Measures
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Interstitial glucose
Time Frame: The 24 hours before and the 24 hours after each visit
|
Continuous Glucose Monitoring system used by the participant in daily life
|
The 24 hours before and the 24 hours after each visit
|
|
Capillary blood lactate
Time Frame: At rest before exercise, then at 10 and 20 min of exercise, at 2 min of active recovery post-exercise, and at 10 min of passive recovery post-exercise.
|
Measured using the Lactate Scout device.
|
At rest before exercise, then at 10 and 20 min of exercise, at 2 min of active recovery post-exercise, and at 10 min of passive recovery post-exercise.
|
|
Oxygen consumption
Time Frame: During a 5-min rest before exercise, a 3-min warm-up, 20-min of exercise, a 2-min active recovery post-exercise, and a 10-min passive recovery post-exercise.
|
Measured with a mask and a Vynthus CPX, Vyaire Medical
|
During a 5-min rest before exercise, a 3-min warm-up, 20-min of exercise, a 2-min active recovery post-exercise, and a 10-min passive recovery post-exercise.
|
|
Rate of Perveived Exertion
Time Frame: At rest before the exercise, and then at 5-min, 10-min, 15-min and 20-min of exercise, at 2-min active recovery post-exercise and at 5 and 10-min passive recovery post-exercise.
|
Rate of Perveived Exertion from the Borg Scale (6 to 20 scale)
|
At rest before the exercise, and then at 5-min, 10-min, 15-min and 20-min of exercise, at 2-min active recovery post-exercise and at 5 and 10-min passive recovery post-exercise.
|
|
Variation of muscle blood volume.
Time Frame: During a 5-min rest before exercise, a 3-min warm-up, 20-min of exercise, a 2-min active recovery post-exercise, and a 5-min passive recovery post-exercise.
|
Measured with Near infrared spectroscopy (Artinis, PortaLite)
|
During a 5-min rest before exercise, a 3-min warm-up, 20-min of exercise, a 2-min active recovery post-exercise, and a 5-min passive recovery post-exercise.
|
|
Heart rate
Time Frame: During a 5-min rest before exercise, a 3-min warm-up, 20-min of exercise, a 2-min active recovery post-exercise, and a 10-min passive recovery post-exercise.
|
Measured with Polar V800.
|
During a 5-min rest before exercise, a 3-min warm-up, 20-min of exercise, a 2-min active recovery post-exercise, and a 10-min passive recovery post-exercise.
|
|
Perceived pleasure
Time Frame: At the end of 10-min passive recovery post-exercise.
|
Physical activity enjoyment scale (PACES) 18 items rated on a 7-point Likert scale.
|
At the end of 10-min passive recovery post-exercise.
|
Collaborators and Investigators
Sponsor
Sponsor
Study record dates
Study Major Dates
Study Start (Actual)
Study Start
Primary Completion (Actual)
Primary Completion
Study Completion (Actual)
Study Completion
Study Registration Dates
First Submitted
First Submitted
First Submitted That Met QC Criteria
First Submitted That Met QC Criteria
First Posted (Actual)
First Posted
Study Record Updates
Last Update Posted (Actual)
Last Update Posted
Last Update Submitted That Met QC Criteria
Last Update Submitted That Met QC Criteria
Last Verified
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
Other Study ID Numbers
- IRB00012476-2023-08-02-225
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
IPD Plan Description
IPD Sharing Time Frame
IPD Sharing Access Criteria
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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