Type 1 DiabetesNCT04418869
Exercise in Adolescents With Type 1 Diabetes
A study testing Exercise bouts in people with Type 1 Diabetes, run by Region Örebro County.
Trial 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. Read more about this study
- Who is it for?
- Ages 16 to 18 years, men only
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- Exercise bouts
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 8 participants
- Where
- No sites listed yet
- Study dates
- 1 Mar 2014to Jun 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 16 to 18 years
- Men only
- No healthy volunteers
- Child, Adult
Who may be able to join
- Male
- Type 1 diabetes
- HbA1c < 65 mol/mol at inclusion
- Regularly performing physical activity
- Aged 16-18 years old
Who cannot join
- Less than 0.5 U/kg in insulin requirements
- Duration of diabetes less than one year.
About this study
Official title: 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.
- Conditions
- Type 1 Diabetes
- Being tested
- Exercise bouts
- Keywords
- Type 1 diabetes, Exercise, Adolescents
- Medical subject headings
- Diabetes Mellitus, Type 1, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise boutsOther
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.
| Study group | Role | What they receive |
|---|---|---|
| Exercise | Experimental | All subject will perform three different exercise bouts and one control session. Receives: Other: Exercise bouts |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in plasma glucose during exercise and recovery
Plasma glucose (mmol/l) measured by an hand-held glucometer
Measured: 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 outcomes (7)
Sensor glucose
Blinded continuous glucose measurement (mmol/l) were used to measure sensor glucose
Measured: 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
Insulin, glucagon, catecholamines, insulin-like growth factor I, cortisol, growth hormone
Measured: 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.
mRNA levels were analyzed with microarray from muscle biopsies and compared between exercise bouts and baseline.
Measured: 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.
mRNA levels were analyzed with microarray from muscle biopsies and compared between the exercise bouts.
Measured: One biopsy was collected appr. 60 minutes after each exercise bout.
Change in heart rate during exercise.
Heart rate (beats per minute) were monitored by pulse oximetry and compared between the exercise bouts.
Measured: 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.
Hemoglobin saturation (SpO2 %) was monitored by pulse oximetry and compared between the exercise bouts.
Measured: 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.
Cardiac output (L/min) was measured with Physioflow and compared between the exercise bouts.
Measured: Cardiac output was measured continuously during exercise from 5 minutes before start of exercise until the bout was finished (time-point 45 minutes).
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Jun 2020
- Study start1 Mar 2014
- Primary completion27 Jun 2016
- Study completionJun 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 1 DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 8 participants (actual)
Sponsor and investigators
- Lead sponsor
- Region Örebro County
- Sponsor type
- University, hospital or other
- Collaborators
- Örebro University, Sweden
- Responsible party
- Sponsor
- Investigators
- Fawzi Kadi, Professor, Study chair, School of health Sciences, Örebro University, Sweden
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04418869
- Sponsor's protocol ID
- 251981
- Status last verified
- Mar 2021
- First submitted
- 15 May 2020
- Last updated
- 31 Oct 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 31 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Metabolic Effects of Exercise in Adolescents With Type 1 Diabetes
- ClinicalTrials.gov ID
- NCT04418869
- Acronym / sponsor ID
- 251981
- Conditions
- Type 1 Diabetes
- Keywords
- Type 1 diabetes, Exercise, Adolescents
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 8 participants (actual)
- Lead sponsor
- Region Örebro CountyUniversity, hospital or other
- Collaborators
- Örebro University, Sweden
- Study start
- 1 Mar 2014 (actual)
- Primary completion
- 27 Jun 2016 (actual)
- Study completion
- Jun 2024 (estimated)
- First posted
- 5 Jun 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Basic science
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Exercise | Experimental | Other: Exercise boutsAll subject will perform three different exercise bouts and one control session. |
Who may qualify
- Ages
- 16 to 18 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Male
- Type 1 diabetes
- HbA1c < 65 mol/mol at inclusion
- Regularly performing physical activity
- Aged 16-18 years old
Key exclusion criteria (2 listed)
- Less than 0.5 U/kg in insulin requirements
- Duration of diabetes less than one year.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Exercise boutsEach 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. | Other | Exercise |
Primary outcome
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
7 secondary outcomes
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).
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
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.
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.
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).
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).
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).
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 31 Oct 2022.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Fawzi Kadi, Professor study chair
School of health Sciences, Örebro University, Sweden
Questions about this trial
What is this clinical trial studying?
A study testing Exercise bouts in people with Type 1 Diabetes, run by Region Örebro County.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 31 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
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.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 31 Oct 2022; AzTrials last refreshed its copy on 27 Oct 2026.