- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04418869
Exercise in Adolescents With Type 1 Diabetes
Metabolic Effects of Exercise in Adolescents With Type 1 Diabetes
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.
Study Overview
Status
Conditions
Intervention / Treatment
Study Type
Enrollment (Actual)
Phase
- Not Applicable
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
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.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Basic Science
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Experimental: Exercise
All subject will perform three different exercise bouts and one control session.
|
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.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Change in plasma glucose during exercise and recovery
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.
|
Plasma glucose (mmol/l) measured by an hand-held glucometer
|
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 Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
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).
|
Blinded continuous glucose measurement (mmol/l) were used to measure sensor glucose
|
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).
|
|
Changes in levels of hormones during exercise and recovery
Time Frame: Serum samples were collected at baseline and after 15 ,30 ,45 of exercise and after 15 minutes of recovery for later analysis
|
Insulin, glucagon, catecholamines, insulin-like growth factor I, cortisol, growth hormone
|
Serum samples were collected at baseline and after 15 ,30 ,45 of exercise and after 15 minutes of recovery for later analysis
|
|
Change in levels of messenger ribonucleic acid (mRNA) between baseline and exercise.
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.
|
mRNA levels were analyzed with microarray from muscle biopsies and compared between exercise bouts and baseline.
|
One biopsy (baseline) were collected approximately one week before the first exercise bout and thereafter one biopsy appr. 60 minutes after each exercise bout.
|
|
Comparisons of levels of messenger ribonucleic acid (mRNA) between different exercise bouts.
Time Frame: One biopsy was collected appr. 60 minutes after each exercise bout.
|
mRNA levels were analyzed with microarray from muscle biopsies and compared between the exercise bouts.
|
One biopsy was collected appr. 60 minutes after each exercise bout.
|
|
Change in heart rate during exercise.
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).
|
Heart rate (beats per minute) were monitored by pulse oximetry and compared between the exercise bouts.
|
Heart rate was monitored continuously during exercise from 5 minutes before start of exercise until the bout was finished (time-point 45 minutes).
|
|
Change in hemoglobin saturation during exercise.
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).
|
Hemoglobin saturation (SpO2 %) was monitored by pulse oximetry and compared between the exercise bouts.
|
Hemoglobin saturation was measured continuously during exercise from 5 minutes before start of exercise until the bout was finished (time-point 45 minutes).
|
|
Change in cardiac output.
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).
|
Cardiac output (L/min) was measured with Physioflow and compared between the exercise bouts.
|
Cardiac output was measured continuously during exercise from 5 minutes before start of exercise until the bout was finished (time-point 45 minutes).
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Study Chair: Fawzi Kadi, Professor, School of health Sciences, Örebro University, Sweden
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
Other Study ID Numbers
- 251981
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
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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