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

RecruitingNAAges 50 Years - 74 YearsAllNational Medical Research Center for Therapy and …
NCT07574333 on ClinicalTrials.gov ↗
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In plain words

What the trial is, and whether it could suit you

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.

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📋 Eligibility rules (as published)
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
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What it tests

  • Intermittent Hypoxic-Hyperoxic Training (3 days)
  • Intermittent Hypoxic-Hyperoxic Training (10 days)
  • Normoxic gas breathing
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Where

1 site
National Medical Research Center for Therapy and Preventive Medicine
Moscow, Russia
🤝 Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible — always decide together with your own doctor.
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