type1diabetesNCT04450745
Physical Exercise in Normobaric Hypoxia and Normoxia in Type 1 Diabetic Patients
A study testing Exercise in hypoxia and Exercise in normoxia in people with type1diabetes, run by Silesian Centre for Heart Diseases at 1 site in Poland.
Trial summary
Physical activity, along with proper nutrition, is the basis for the behavioral treatment of diabetes. In recent years exercise training in normobaric hypoxia is used in training programs for athletes and in rehabilitation. Read more about this study
- Who is it for?
- Ages 30 to 45 years, men only
- Conditions the study is for
- type1diabetes
- What is being tested?
- Exercise in hypoxia and Exercise in normoxia
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 16 participants
- Where
- 1 sitePoland
- Study dates
- 30 Oct 2019to 30 Sep 2020
- 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 30 to 45 years
- Men only
- No healthy volunteers
- Adult
Who may be able to join
- type 1 diabetes of at least 10 years duration
- low physical activity
- BMI 20-30 kg/m2
- treated with multiple insulin injections (at least 4) or insulin pump (continuous subcutaneous insulin infusion [CSII])
- negative ECG exercise test
- HbA1c ≤ 8,0%
- high knowledge about functional insulin therapy, carbohydrate counting and diabetes management during exercise
- use of advanced glucometer functions and experience in use of Free Style Libre (Flash Glucose Monitoring System, Abbott)
Who cannot join
- HbA1c > 8,0%,
- advanced complications of diabetes [pre-proliferative or proliferative retinopathy, and previous laser therapy, microalbuminuria or overt nephropathy, autonomic neuropathy (including lack of elevated heart rate during physical activity)]
- patients physically active (regular physical activities more than once a week),
- positive ECG exercise test, history of cardiovascular event or coronary heart disease.
Trial locations and contacts
1 site in 1 country.
Poland1 site
Department of Internal Diseases, Diabetology and Cardiometabolic Disorders, School of Medicine with the Division of Dentistry in Zabrze, Medical University of Silesia in Katowice, Poland
Zabrze, Silesian Voivodeship, 41-800
About this study
Physical activity, along with proper nutrition, is the basis for the behavioral treatment of diabetes. In recent years exercise training in normobaric hypoxia is used in training programs for athletes and in rehabilitation. The aim of this study is the assessment of physical exercise in normobaric hypoxia condition on metabolic control of diabetes: blood glucose profile, its stability, HbA1c value, hypoglycemia: frequency, level, severity and time of occurrence, insulin demand, maximal muscle strength level, VO2max and anthropometric parameters.
Read the detailed description
Hypoxia leads to HIF-1 production (hypoxia inducible factor 1) which regulates expression of many genes (eg. gene responsible for erythropoetin production). It also stimulates angiogenesis, muscle hypertrophy and glycolytic energy production by transactivating genes involved in extracellular glucose import.
Before starting the training program all participants will be assessed by cardiologist. Then the incremental exercise test will be performed to determine aerobic capacity (VO2max).
Recruited patients ( type 1 male diabetic patients) will be divided into 2 arms: exercise in normoxia or in normobaric hypoxia. Hypoxic chamber is set to contain equivalent to an altitude of 2500 meters above see level (indoor air composition: 15,4% of O2 and 84,7% of N).
Training program will be the same for all participants: 60 minutes sessions twice a week for 6 weeks of mixed exercise: aerobic and anaerobic.
Glycemia will be monitored by Flash Glucose Monitoring (Free Style Libre) and the same glucometer model by all patients.
At baseline and after 6 weeks: echocardiography, ECG and incremental exercise test, ECG and blood pressure monitoring, lipid profile and diabetes control parameters will be performed in all patients.
- Conditions
- type1diabetes
- Being tested
- Exercise in hypoxia, Exercise in normoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Exercise in hypoxiaBehavioural
60 minutes training program of mixed exercise in normobaric hypoxic chamber
Exercise in normoxiaBehavioural
60 minutes training program of mixed exercise in regular air conditions
| Study group | Role | What they receive |
|---|---|---|
| Exercise in hypoxia | Experimental | Patients randomized to this arm will have training program in normobaric hypoxic chamber set to contain equivalent to an altitude of 2500 meters above see level( indoor air composition: 15,4% of O2 and 84,7% of N) Receives: Behavioral: Exercise in hypoxia |
| Exercise in normoxia | Experimental | Patients randomized to this arm will have the same training program in normoxic conditions Receives: Behavioral: Exercise in normoxia |
What is being measured
The primary outcome is the main question the study is designed to answer.
Maximum oxygen consumption (VO2max)
measured during Incremental exercise test
Measured: 6 weeks
Metabolic control of diabetes
HbA1c (%,mmol/mol)
Measured: 6 weeks
Glucose stability
Time In Range (TIR, %) while using Continous Glucose Monitoring System
Measured: 6 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jun 2020
- Study start30 Oct 2019
- Primary completion31 Aug 2020
- Study completion30 Sep 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for type1diabetesStudies 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 16 participants (actual)
Sponsor and investigators
- Lead sponsor
- Silesian Centre for Heart Diseases
- Sponsor type
- University, hospital or other
- Collaborators
- The Jerzy Kukuczka Academy of Physical Education in Katowice
- Responsible party
- Sponsor
- Investigators
- Krzysztof Strojek, Professor, Study chair, Department of Internal Diseases, Diabetology and Cardiometabolic Disorders, School of Medicine with the Division of Dentistry in Zabrze, Medical University of Silesia in Katowice, PolandMarta Wróbel, PhD, Principal investigator, Department of Internal Diseases, Diabetology and Cardiometabolic Disorders, School of Medicine with the Division of Dentistry in Zabrze, Medical University of Silesia in Katowice, Poland
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04450745
- Sponsor's protocol ID
- Hypoxia-DiabetesT1
- Status last verified
- Apr 2022
- First submitted
- 21 Jun 2020
- Last updated
- 28 Apr 2022
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Apr 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Physical Exercise in Normobaric Hypoxia and Normoxia in Type 1 Diabetic Patients
- ClinicalTrials.gov ID
- NCT04450745
- Acronym / sponsor ID
- Hypoxia-DiabetesT1
- Conditions
- type1diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 16 participants (actual)
- Lead sponsor
- Silesian Centre for Heart DiseasesUniversity, hospital or other
- Collaborators
- The Jerzy Kukuczka Academy of Physical Education in Katowice
- Study start
- 30 Oct 2019 (actual)
- Primary completion
- 31 Aug 2020 (actual)
- Study completion
- 30 Sep 2020 (actual)
- First posted
- 30 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.
Physical activity, along with proper nutrition, is the basis for the behavioral treatment of diabetes. In recent years exercise training in normobaric hypoxia is used in training programs for athletes and in rehabilitation. The aim of this study is the assessment of physical exercise in normobaric hypoxia condition on metabolic control of diabetes: blood glucose profile, its stability, HbA1c value, hypoglycemia: frequency, level, severity and time of occurrence, insulin demand, maximal muscle strength level, VO2max and anthropometric parameters.
Detailed description
Hypoxia leads to HIF-1 production (hypoxia inducible factor 1) which regulates expression of many genes (eg. gene responsible for erythropoetin production). It also stimulates angiogenesis, muscle hypertrophy and glycolytic energy production by transactivating genes involved in extracellular glucose import.
Before starting the training program all participants will be assessed by cardiologist. Then the incremental exercise test will be performed to determine aerobic capacity (VO2max).
Recruited patients ( type 1 male diabetic patients) will be divided into 2 arms: exercise in normoxia or in normobaric hypoxia. Hypoxic chamber is set to contain equivalent to an altitude of 2500 meters above see level (indoor air composition: 15,4% of O2 and 84,7% of N).
Training program will be the same for all participants: 60 minutes sessions twice a week for 6 weeks of mixed exercise: aerobic and anaerobic.
Glycemia will be monitored by Flash Glucose Monitoring (Free Style Libre) and the same glucometer model by all patients.
At baseline and after 6 weeks: echocardiography, ECG and incremental exercise test, ECG and blood pressure monitoring, lipid profile and diabetes control parameters will be performed in all patients.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Exercise in hypoxia | Experimental | Behavioral: Exercise in hypoxiaPatients randomized to this arm will have training program in normobaric hypoxic chamber set to contain equivalent to an altitude of 2500 meters above see level( indoor air composition: 15,4% of O2 and 84,7% of N) |
| Exercise in normoxia | Experimental | Behavioral: Exercise in normoxiaPatients randomized to this arm will have the same training program in normoxic conditions |
Who may qualify
- Ages
- 30 to 45 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (8 listed)
- type 1 diabetes of at least 10 years duration
- low physical activity
- BMI 20-30 kg/m2
- treated with multiple insulin injections (at least 4) or insulin pump (continuous subcutaneous insulin infusion [CSII])
- negative ECG exercise test
Key exclusion criteria (4 listed)
- HbA1c > 8,0%,
- advanced complications of diabetes [pre-proliferative or proliferative retinopathy, and previous laser therapy, microalbuminuria or overt nephropathy, autonomic neuropathy (including lack of elevated heart rate during physical activity)]
- patients physically active (regular physical activities more than once a week),
- positive ECG exercise test, history of cardiovascular event or coronary heart disease.
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 in hypoxia60 minutes training program of mixed exercise in normobaric hypoxic chamber | Behavioural | Exercise in hypoxia |
| Exercise in normoxia60 minutes training program of mixed exercise in regular air conditions | Behavioural | Exercise in normoxia |
Primary outcome
Maximum oxygen consumption (VO2max)
Time frame: 6 weeks
measured during Incremental exercise test
Metabolic control of diabetes
Time frame: 6 weeks
HbA1c (%,mmol/mol)
Glucose stability
Time frame: 6 weeks
Time In Range (TIR, %) while using Continous Glucose Monitoring System
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Apr 2022.
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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.
Krzysztof Strojek, Professor study chair
Department of Internal Diseases, Diabetology and Cardiometabolic Disorders, School of Medicine with the Division of Dentistry in Zabrze, Medical University of Silesia in Katowice, Poland
Marta Wróbel, PhD principal investigator
Department of Internal Diseases, Diabetology and Cardiometabolic Disorders, School of Medicine with the Division of Dentistry in Zabrze, Medical University of Silesia in Katowice, Poland
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Exercise in hypoxia and Exercise in normoxia in people with type1diabetes, run by Silesian Centre for Heart Diseases at 1 site in Poland.
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 8 inclusion and 4 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: finished, as of the sponsor's last update on 28 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
Maximum oxygen consumption (VO2max) (time frame: 6 weeks). The study lists 3 primary outcomes in all. 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 28 Apr 2022.