Physical Exercise in Normobaric Hypoxia and Normoxia in Type 1 Diabetic Patients (NCT04450745) | Clinical Trial Compass
CompletedNot Applicable
Physical Exercise in Normobaric Hypoxia and Normoxia in Type 1 Diabetic Patients
Poland16 participantsStarted 2019-10-30
Plain-language 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. 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.
Who can participate
Age range
30 Years – 45 Years
Sex
MALE
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* 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)
Exclusion Criteria:
* 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.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.