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

Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50-74
SponsorNational Medical Research Center for Therapy and Preventive Medicine

About this trial

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

Qualifiers

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

Disqualifiers

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

Trial design

Treatments tested in this trial

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

Treatment groups

250 Participants
are divided into 3 treatment groups