Effects of Short and Long Courses of Intermittent Hypoxic-Hyperoxic Training in Patients With Type 2 Diabetes Including Elderly
Recruiting now · Not applicable · Has a placebo group
Conditions studied: Type 2 Diabetes Mellitus (T2DM), Hyperglycemia, Metabolic Syndrome, Older Adults (65 Years and Older)
In brief
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.
Key facts
- Study ID
- NCT07574333
- Run by
- National Medical Research Center for Therapy and Preventive Medicine
- People needed
- 250
- Starts
- 2025-10-15
- Expected to finish
- 2027-12-15
- Last updated by the study team
- 2026-05-07
Who can join
Age: 50 and older, up to 74. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- National Medical Research Center for Therapy and Preventive Medicine — Moscow, Russia (enrolling)
Full record on ClinicalTrials.gov
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