Effects of Short and Long Courses of Intermittent Hypoxic-Hyperoxic Training in Patients With Typ… (NCT07574333) | Clinical Trial Compass
RecruitingNot Applicable
Effects of Short and Long Courses of Intermittent Hypoxic-Hyperoxic Training in Patients With Type 2 Diabetes Including Elderly
Russia250 participantsStarted 2025-10-15
Plain-language summary
This is a single-center randomized controlled trial evaluating the efficacy and safety of short (3 days) versus long (10 days) courses of intermittent hypoxic-hyperoxic training (IHHT) in patients with type 2 diabetes mellitus aged 50-74 years. Participants will be randomized into three groups: 3-day IHHT course (n≥100), 10-day IHHT course (n≥100), or control group receiving gas mixture with constant O2 21% for 10 days (n≥50). The primary outcomes are fasting glucose levels and HbA1c. Secondary outcomes include cardiovascular parameters, quality of life, cognitive function, and biological age.
Who can participate
Age range
50 Years – 74 Years
Sex
ALL
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:
* Age 50-74 years inclusive
* Type 2 diabetes mellitus confirmed by medical documentation
* Stable therapy for diabetes and other chronic diseases for at least 4 weeks prior to enrollment
* Ability to comply with study protocol requirements
* Signed informed consent
Exclusion Criteria:
* Type 1 diabetes mellitus
* Acute diabetes complications within 6 months (diabetic ketoacidosis, hyperosmolar hyperglycemic state, lactic acidosis, hypoglycemic coma)
* Acute or active chronic infections
* Angina pectoris functional class III-IV
* Uncontrolled grade 3 arterial hypertension (SBP ≥180 and/or DBP ≥110 mmHg)
* Acute cerebrovascular accident, myocardial infarction, surgical interventions, clinically significant injuries within 6 months
* Internal carotid artery stenosis \>60% and/or symptomatic stenosis 50-99%
* Chronic obstructive pulmonary disease and bronchial asthma
* Exacerbation and decompensation of chronic diseases within 1 month ALT and/or AST levels \>2-3 times upper limit of normal
* Congenital heart and major vessel abnormalities
* Implanted cardiac pacemaker
* Cancer with remission \<5 years
* Mental illness, drug addiction, alcohol dependence
* Pregnancy
* Inability to participate throughout the study period
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.
What they're measuring
1
Change in fasting glucose level (mmol/L) from baseline to 30±3 days after intervention completion
Timeframe: Baseline, day 30
2
Change in HbA1c (%) from baseline to 30±3 days after intervention completion
Timeframe: Baseline, day 30
Trial details
NCT IDNCT07574333
SponsorNational Medical Research Center for Therapy and Preventive Medicine