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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Enrollment
250
Three daily sessions using HYPO-OXY-1 (OXYTERRA) device
Ten daily sessions using HYPO-OXY-1 (OXYTERRA) device
Ten daily sessions of breathing gas mixture with constant O2 21%
National Medical Research Center for Therapy and Preventive Medicine
Moscow, Russia
RECRUITINGChange in fasting glucose level (mmol/L) from baseline to 30±3 days after intervention completion
Fasting glucose will be measured after 8-12 hours of fasting using immunoturbidimetric method (Architect 8000C analyzer)
Time frame: Baseline, day 30
Change in HbA1c (%) from baseline to 30±3 days after intervention completion
HbA1c will be measured using high-performance liquid chromatography (HPLC) on Lifotronic H8 analyzer
Time frame: Baseline, day 30
Change in Cardio-Ankle Vascular Index (CAVI)
Time frame: Baseline, day 17-19, day 30
Change in flow-mediated vasodilation (%)
Time frame: Baseline, day 17-19, day 30 post-intervention
Change in 24-hour ambulatory blood pressure
Time frame: Baseline and 30±3 days post-intervention
Change in quality of life by SF-36
SF-36 is a 36-item patient-reported survey measuring health-related quality of life across 8 domains. Each domain is scored on a 0-100 scale, where higher scores indicate better quality of life.
Time frame: Baseline, day 17-19, and 30±3 days post-intervention
Change in cognitive function by MoCA scale
Montreal Cognitive Assessment scores range from 0-30, with scores ≥26 considered normal cognitive function
Time frame: Baseline, day 17-19, and 30±3 days post-intervention
Change in anxiety and depression by HADS
Hospital Anxiety and Depression Scale assesses anxiety and depression separately, each scored 0-21, with higher scores indicating greater symptom severity
Time frame: Baseline, day 17-19, and 30±3 days post-intervention
Change in biological age
Time frame: Baseline and 30±3 days post-intervention
Change in 6-minute walk test distance (meters)
Time frame: Baseline and 30±3 days post-intervention
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