Type 1 DiabetesNCT06345612
Impact of Eccentric Training in Hypoxia With Creatine on Metabolic Control and VO2max in Patients With Type 1 Diabetes
A study testing hypoxia, normoxia and creatine supplementation in people with Type 1 Diabetes, run by Silesian Centre for Heart Diseases at 1 site in Poland.
Trial summary
Exercise plays an important role in treatment of diabetes. In recent years exercise training in normobaric hypoxia is used in training programs for athletes and in rehabilitation and also commercially. Read more about this study
- Who is it for?
- Ages 20 to 45 years, men only
- Conditions the study is for
- Type 1 Diabetes
- What is being tested?
- hypoxia, normoxia and creatine supplementation
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 28 participants
- Where
- 1 sitePoland
- Study dates
- 15 Nov 2023to 30 Mar 2025
- 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 20 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:20-31 kg/m2,
- treated with multiple insulin injections (at least 4 daily) or insulin pump (continuous subcutaneous insulin infusion [CSII]),
- negative ECG exercise test,
- HbA1c ≤ 8,0%,
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- high knowledge about functional insulin therapy, carbohydrate counting and diabetes management during exercise,
- experience in use of FreeStyleLibre2 (Flash Glucose Monitoring System, Abbott),
- Informed consent to participate in research signed by enrolled subjects
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
Official title: Impact of Eccentric Training Conducted in the Conditions of Normobaric Hypoxia, Normoxia and Creatine Supplementation on Metabolic Control, Muscle Strength Level, Maximum Oxygen Consumption (VO2max) in Patients With Type 1diabetes Mellitus
Exercise plays an important role in treatment of diabetes. In recent years exercise training in normobaric hypoxia is used in training programs for athletes and in rehabilitation and also commercially. The aim of the study is to assess the impact of eccentric training conducted in conditions of normobaric hypoxia or normoxia and creatine supplementation on metabolic control: profile and stability of glucose concentration, HbA1c value, hypoglycemia and insulin demand, as well as the level of muscle strength, VO2max and anthropometric parameters
Read the detailed description
People with type 1 diabetes benefit from training in normobaric hypoxia - the composition of the air in the training room is: 15.4% oxygen 84.7% nitrogen, which corresponds to hypoxia at an altitude of 2,500 m above sea level. Hypoxia leads to the production of HIF-1 (hypoxia-inducible transcription factor ), which is a regulator of the expression of many genes responsible for angiogenesis, muscle hypertrophy and glucose stability.
Before starting the10 - week training program all participants will undergo preliminary examination by a cardiologist during which echocardiography and ECG will be conducted. Then the incremental exercise test and muscle strength test will be performed to determine aerobic capacity (VO2max) and select individual weights to train for each participant.
Patients enrolled to the study will be randomly assigned to one of the following 2 groups (training under normoxia or hypoxia conditions) and subgroups (with and without supplementation of creatine).
Randomization will be carried out in blocks of 4 people.
Training sessions will take place with the assistance of a personal trainer in the Hypoxia Laboratory and the Muscle Strength and Power Laboratory of Academy of Physical Education in Katowice twice a week for 60 minutes for a period of 10 weeks. The subjects will complete the same eccentric training program with individually selected weights.
Within whole training period glucose level will be monitored via Flash Glucose Monitoring system (Free Style Libre2). During training sessions concentration of asprosin (protein hormone encoded by the C-terminal region of the FBN1 gene, which encodes fibrillin-1 protein), irisin, GH (growth hormone), IGF-1 (Insulin-like growth factor-1) within blood serum immediately before and after the first and last training will be assessed.
At baseline and after 10 weeks blood count, Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), creatinine, GFR (glomerular filtration rate), HbA1c, ACR (albumin-creatinine ratio) in a random urine sample, body weight, BMI, waist-hip circumference, body composition, quality of life according to the EQ-5D-5L (EuroQol Five-Dimension Five-Level scale), daily insulin requirement, incremental exercise test, muscle strength test (10RM-10 repetition maximum) will be investigated among all participants.
- Conditions
- Type 1 Diabetes
- Being tested
- hypoxia, normoxia, creatine supplementation, no creatine supplementation
- Keywords
- exercise, eccentric exercise, hypoxia, type 1 diabetes
- Medical subject headings
- Diabetes Mellitus, Type 1, Motor Activity, Hypoxia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hypoxiaBehavioural
eccentric training program conducted within normobaric hypoxic chamber
normoxiaBehavioural
eccentric training program conducted within normoxic conditions
creatine supplementationDietary supplement
5g of creatine per day
no creatine supplementationDietary supplement
no creatine supplementation
| Study group | Role | What they receive |
|---|---|---|
| 1. exercise in hypoxia with creatine supplementation | Experimental | * training program in normobaric hypoxic chamber set to contain equivalent to an altitude of 2500 meters above sea level (indoor air composition: 15,4% of O2 and 84,7% of N)
* with creatine supplementation Receives: Behavioral: hypoxia; Dietary Supplement: creatine supplementation |
| 2. exercise in hypoxia without creatine supplementation | Experimental | * training program in normobaric hypoxic chamber set to contain equivalent to an altitude of 2500 meters above sea level (indoor air composition: 15,4% of O2 and 84,7% of N)
* without creatine supplementation Receives: Behavioral: hypoxia; Dietary Supplement: no creatine supplementation |
| 3. exercise in normoxia with creatine supplementation | Experimental | * the same training program in normoxic conditions
* with creatine supplementation Receives: Behavioral: normoxia; Dietary Supplement: creatine supplementation |
| 4.exercise in normoxia without creatine supplementation | Experimental | * the same training program in normoxic conditions
* without creatine supplementation Receives: Behavioral: normoxia; Dietary Supplement: no creatine supplementation |
What is being measured
The primary outcome is the main question the study is designed to answer.
Metabolic control of diabetes
HbA1c (%, mmol/mol)
Measured: before and after 10 weeks
Time in range (TIR)
TIR- percentage of time with blood glucose in a target range: 70-180 mg/dl (%)
Measured: before and after 10 weeks
Time below range (TBR)
TBR - percentage of time with blood glucose levels<70 mg/dl (%)
Measured: before and after 10 weeks
Maximum oxygen consumption (VO2max)
measured during incremental exercise test
Measured: before and after 10 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Apr 2024
- Study start15 Nov 2023
- Primary completion30 Mar 2025
- Study completion30 Mar 2025
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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Silesian Centre for Heart Diseases
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Krzysztof Strojek, Prof., Study chair, Medical University of Silesia in Katowice
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06345612
- Sponsor's protocol ID
- Hypoxia-Exercise-DiabetesT1
- Status last verified
- Feb 2024
- First submitted
- 23 Feb 2024
- Last updated
- 7 May 2026
- 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 7 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Impact of Eccentric Training Conducted in the Conditions of Normobaric Hypoxia, Normoxia and Creatine Supplementation on Metabolic Control, Muscle Strength Level, Maximum Oxygen Consumption (VO2max) in Patients With Type 1diabetes Mellitus
- ClinicalTrials.gov ID
- NCT06345612
- Acronym / sponsor ID
- Hypoxia-Exercise-DiabetesT1
- Conditions
- Type 1 Diabetes
- Keywords
- exercise, eccentric exercise, hypoxia, type 1 diabetes
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Silesian Centre for Heart DiseasesUniversity, hospital or other
- Study start
- 15 Nov 2023 (actual)
- Primary completion
- 30 Mar 2025 (actual)
- Study completion
- 30 Mar 2025 (actual)
- First posted
- 3 Apr 2024 (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.
Exercise plays an important role in treatment of diabetes. In recent years exercise training in normobaric hypoxia is used in training programs for athletes and in rehabilitation and also commercially. The aim of the study is to assess the impact of eccentric training conducted in conditions of normobaric hypoxia or normoxia and creatine supplementation on metabolic control: profile and stability of glucose concentration, HbA1c value, hypoglycemia and insulin demand, as well as the level of muscle strength, VO2max and anthropometric parameters
Detailed description
People with type 1 diabetes benefit from training in normobaric hypoxia - the composition of the air in the training room is: 15.4% oxygen 84.7% nitrogen, which corresponds to hypoxia at an altitude of 2,500 m above sea level. Hypoxia leads to the production of HIF-1 (hypoxia-inducible transcription factor ), which is a regulator of the expression of many genes responsible for angiogenesis, muscle hypertrophy and glucose stability.
Before starting the10 - week training program all participants will undergo preliminary examination by a cardiologist during which echocardiography and ECG will be conducted. Then the incremental exercise test and muscle strength test will be performed to determine aerobic capacity (VO2max) and select individual weights to train for each participant.
Patients enrolled to the study will be randomly assigned to one of the following 2 groups (training under normoxia or hypoxia conditions) and subgroups (with and without supplementation of creatine).
Randomization will be carried out in blocks of 4 people.
Training sessions will take place with the assistance of a personal trainer in the Hypoxia Laboratory and the Muscle Strength and Power Laboratory of Academy of Physical Education in Katowice twice a week for 60 minutes for a period of 10 weeks. The subjects will complete the same eccentric training program with individually selected weights.
Within whole training period glucose level will be monitored via Flash Glucose Monitoring system (Free Style Libre2). During training sessions concentration of asprosin (protein hormone encoded by the C-terminal region of the FBN1 gene, which encodes fibrillin-1 protein), irisin, GH (growth hormone), IGF-1 (Insulin-like growth factor-1) within blood serum immediately before and after the first and last training will be assessed.
At baseline and after 10 weeks blood count, Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), creatinine, GFR (glomerular filtration rate), HbA1c, ACR (albumin-creatinine ratio) in a random urine sample, body weight, BMI, waist-hip circumference, body composition, quality of life according to the EQ-5D-5L (EuroQol Five-Dimension Five-Level scale), daily insulin requirement, incremental exercise test, muscle strength test (10RM-10 repetition maximum) will be investigated among all participants.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 1. exercise in hypoxia with creatine supplementation | Experimental | Behavioral: hypoxia, Dietary Supplement: creatine supplementation* training program in normobaric hypoxic chamber set to contain equivalent to an altitude of 2500 meters above sea level (indoor air composition: 15,4% of O2 and 84,7% of N) * with creatine supplementation |
| 2. exercise in hypoxia without creatine supplementation | Experimental | Behavioral: hypoxia, Dietary Supplement: no creatine supplementation* training program in normobaric hypoxic chamber set to contain equivalent to an altitude of 2500 meters above sea level (indoor air composition: 15,4% of O2 and 84,7% of N) * without creatine supplementation |
| 3. exercise in normoxia with creatine supplementation | Experimental | Behavioral: normoxia, Dietary Supplement: creatine supplementation* the same training program in normoxic conditions * with creatine supplementation |
| 4.exercise in normoxia without creatine supplementation | Experimental | Behavioral: normoxia, Dietary Supplement: no creatine supplementation* the same training program in normoxic conditions * without creatine supplementation |
Who may qualify
- Ages
- 20 to 45 years
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (9 listed)
- type 1 diabetes of at least 10 years duration,
- low physical activity,
- BMI:20-31 kg/m2,
- treated with multiple insulin injections (at least 4 daily) or insulin pump (continuous subcutaneous insulin infusion [CSII]),
- negative ECG exercise test,
Key exclusion criteria (5 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 |
|---|---|---|
| hypoxiaeccentric training program conducted within normobaric hypoxic chamber | Behavioural | 1. exercise in hypoxia with creatine supplementation, 2. exercise in hypoxia without creatine supplementation |
| normoxiaeccentric training program conducted within normoxic conditions | Behavioural | 3. exercise in normoxia with creatine supplementation, 4.exercise in normoxia without creatine supplementation |
| creatine supplementation5g of creatine per day | Dietary supplement | 1. exercise in hypoxia with creatine supplementation, 3. exercise in normoxia with creatine supplementation |
| no creatine supplementationno creatine supplementation | Dietary supplement | 2. exercise in hypoxia without creatine supplementation, 4.exercise in normoxia without creatine supplementation |
Primary outcome
Metabolic control of diabetes
Time frame: before and after 10 weeks
HbA1c (%, mmol/mol)
Time in range (TIR)
Time frame: before and after 10 weeks
TIR- percentage of time with blood glucose in a target range: 70-180 mg/dl (%)
Time below range (TBR)
Time frame: before and after 10 weeks
TBR - percentage of time with blood glucose levels<70 mg/dl (%)
Maximum oxygen consumption (VO2max)
Time frame: before and after 10 weeks
measured during incremental exercise test
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 7 May 2026.
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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, Prof. study chair
Medical University of Silesia in Katowice
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing hypoxia, normoxia and creatine supplementation in people with Type 1 Diabetes, 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 9 inclusion and 5 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 7 May 2026. 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?
Metabolic control of diabetes (time frame: before and after 10 weeks). The study lists 4 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 7 May 2026.