NCT07574333 Effects of Short and Long Courses of Intermittent Hypoxic-Hyperoxic Training in Patients With Type 2 Diabetes Including Elderly
| NCT ID | NCT07574333 |
| Status | Recruiting |
| Phase | — |
| Sponsor | National Medical Research Center for Therapy and Preventive Medicine |
| Condition | Type 2 Diabetes Mellitus (T2DM) |
| Study Type | INTERVENTIONAL |
| Enrollment | 250 participants |
| Start Date | 2025-10-15 |
| Primary Completion | 2027-06-15 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 250 participants in total. It began in 2025-10-15 with a primary completion date of 2027-06-15.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief 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.
Eligibility Criteria
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
Contact & Investigator
Marina I Smirnova, PhD
STUDY CHAIR
National Medical Research Center for Therapy and Preventive Medicine
Frequently Asked Questions
Who can join the NCT07574333 clinical trial?
This trial is open to participants of all sexes, aged 50 Years or older, up to 74 Years, studying Type 2 Diabetes Mellitus (T2DM). Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT07574333 currently recruiting?
Yes, NCT07574333 is actively recruiting participants. Contact the research team at dr.chaschin@gmail.com for enrollment information.
Where is the NCT07574333 trial being conducted?
This trial is being conducted at Moscow, Russia.
Who is sponsoring the NCT07574333 clinical trial?
NCT07574333 is sponsored by National Medical Research Center for Therapy and Preventive Medicine. The principal investigator is Marina I Smirnova, PhD at National Medical Research Center for Therapy and Preventive Medicine. The trial plans to enroll 250 participants.
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