Effects of Short and Long Courses of Intermittent Hypoxic-Hyperoxic Training in Patients With Type 2 Diabetes Including Elderly

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

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

Conditions5

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