Exercise in Adolescents With Type 1 Diabetes
Primary Purpose
Type 1 Diabetes
Status
Active
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
Exercise bouts
Sponsored by
About this trial
This is an interventional basic science trial for Type 1 Diabetes focused on measuring Type 1 diabetes, Exercise, Adolescents
Eligibility Criteria
Inclusion Criteria:
- Male
- Type 1 diabetes
- HbA1c < 65 mol/mol at inclusion
- Regularly performing physical activity
- Aged 16-18 years old
Exclusion Criteria:
- Less than 0.5 U/kg in insulin requirements
- Duration of diabetes less than one year.
Sites / Locations
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Exercise
Arm Description
All subject will perform three different exercise bouts and one control session.
Outcomes
Primary Outcome Measures
Change in plasma glucose during exercise and recovery
Plasma glucose (mmol/l) measured by an hand-held glucometer
Secondary Outcome Measures
Sensor glucose
Blinded continuous glucose measurement (mmol/l) were used to measure sensor glucose
Changes in levels of hormones during exercise and recovery
Insulin, glucagon, catecholamines, insulin-like growth factor I, cortisol, growth hormone
Change in levels of messenger ribonucleic acid (mRNA) between baseline and exercise.
mRNA levels were analyzed with microarray from muscle biopsies and compared between exercise bouts and baseline.
Comparisons of levels of messenger ribonucleic acid (mRNA) between different exercise bouts.
mRNA levels were analyzed with microarray from muscle biopsies and compared between the exercise bouts.
Change in heart rate during exercise.
Heart rate (beats per minute) were monitored by pulse oximetry and compared between the exercise bouts.
Change in hemoglobin saturation during exercise.
Hemoglobin saturation (SpO2 %) was monitored by pulse oximetry and compared between the exercise bouts.
Change in cardiac output.
Cardiac output (L/min) was measured with Physioflow and compared between the exercise bouts.
Full Information
NCT ID
NCT04418869
First Posted
May 15, 2020
Last Updated
October 28, 2022
Sponsor
Region Örebro County
Collaborators
Örebro University, Sweden
1. Study Identification
Unique Protocol Identification Number
NCT04418869
Brief Title
Exercise in Adolescents With Type 1 Diabetes
Official Title
Metabolic Effects of Exercise in Adolescents With Type 1 Diabetes
Study Type
Interventional
2. Study Status
Record Verification Date
March 2021
Overall Recruitment Status
Active, not recruiting
Study Start Date
March 1, 2014 (Actual)
Primary Completion Date
June 27, 2016 (Actual)
Study Completion Date
June 2024 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Region Örebro County
Collaborators
Örebro University, Sweden
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
Regular physical activity is an important part of diabetes management in adolescents with type 1 diabetes (T1D). Increased physical activity has several beneficial effects such as improved lipid profile, insulin sensitivity and quality of life. In addition, a reduced HbA1c is often seen in association to increased physical activity. However, the effect on glycemic control and the acute glycemic response seems to differs between different types of exercise. This issue is poorly studied in adolescents with T1D and the mechanism behind this is not fully understood.
The primary aim of this study was to compare the acute effects on glycemia of resistance and two aerobic continuous and intermittent exercise bouts in adolescents with type 1 diabetes. Secondarily, the investigators want to compare the different exercise according to hormonal changes and expression of mRNA in muscle.
At a baseline visit the participants was tested for maximal oxygen consumption (pVO2peak) and maximal strength (1-RM). The study participants then performed three exercise bouts and one control session (resting), each on 45 minutes, in a randomized order. Measurement was performed during and after the exercise.
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, Exercise, Adolescents
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
8 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Exercise
Arm Type
Experimental
Arm Description
All subject will perform three different exercise bouts and one control session.
Intervention Type
Other
Intervention Name(s)
Exercise bouts
Intervention Description
Each subject performed three bouts with 45 minutes of exercise (continuous exercise, intermittent exercise and resistance exercise) in a randomized order. In addition a control session were performed where the subjects sat on a chair for 45 minutes.
Primary Outcome Measure Information:
Title
Change in plasma glucose during exercise and recovery
Description
Plasma glucose (mmol/l) measured by an hand-held glucometer
Time Frame
Plasma glucose were measured at 5 minutes before and at start of the bouts. Thereafter glucose was measured at 5,10,15,30 and 45 minutes during exercise. In addition glucose were measured at 15, 30, 45 and 60 minutes during the initial recovery period.
Secondary Outcome Measure Information:
Title
Sensor glucose
Description
Blinded continuous glucose measurement (mmol/l) were used to measure sensor glucose
Time Frame
Blinded continuous glucose measurement was started when the exercise bouts were finished and were there after used during the next 22 hours (until the next morning at 08:00 am).
Title
Changes in levels of hormones during exercise and recovery
Description
Insulin, glucagon, catecholamines, insulin-like growth factor I, cortisol, growth hormone
Time Frame
Serum samples were collected at baseline and after 15 ,30 ,45 of exercise and after 15 minutes of recovery for later analysis
Title
Change in levels of messenger ribonucleic acid (mRNA) between baseline and exercise.
Description
mRNA levels were analyzed with microarray from muscle biopsies and compared between exercise bouts and baseline.
Time Frame
One biopsy (baseline) were collected approximately one week before the first exercise bout and thereafter one biopsy appr. 60 minutes after each exercise bout.
Title
Comparisons of levels of messenger ribonucleic acid (mRNA) between different exercise bouts.
Description
mRNA levels were analyzed with microarray from muscle biopsies and compared between the exercise bouts.
Time Frame
One biopsy was collected appr. 60 minutes after each exercise bout.
Title
Change in heart rate during exercise.
Description
Heart rate (beats per minute) were monitored by pulse oximetry and compared between the exercise bouts.
Time Frame
Heart rate was monitored continuously during exercise from 5 minutes before start of exercise until the bout was finished (time-point 45 minutes).
Title
Change in hemoglobin saturation during exercise.
Description
Hemoglobin saturation (SpO2 %) was monitored by pulse oximetry and compared between the exercise bouts.
Time Frame
Hemoglobin saturation was measured continuously during exercise from 5 minutes before start of exercise until the bout was finished (time-point 45 minutes).
Title
Change in cardiac output.
Description
Cardiac output (L/min) was measured with Physioflow and compared between the exercise bouts.
Time Frame
Cardiac output was measured continuously during exercise from 5 minutes before start of exercise until the bout was finished (time-point 45 minutes).
10. Eligibility
Sex
Male
Gender Based
Yes
Gender Eligibility Description
Gender is based on personal identity number and self-identification.
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Male
Type 1 diabetes
HbA1c < 65 mol/mol at inclusion
Regularly performing physical activity
Aged 16-18 years old
Exclusion Criteria:
Less than 0.5 U/kg in insulin requirements
Duration of diabetes less than one year.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Fawzi Kadi, Professor
Organizational Affiliation
School of health Sciences, Örebro University, Sweden
Official's Role
Study Chair
12. IPD Sharing Statement
Plan to Share IPD
No
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Exercise in Adolescents With Type 1 Diabetes
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