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

Sponsor
National Medical Research Center for Therapy and Preventive Medicine
Study ID
NCT07574333
Status
Recruiting
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Conditions

  • Hyperglycemia
  • Metabolic Syndrome
  • Older Adults (65 Years and Older)
  • Type 2 Diabetes Mellitus (T2DM)

Eligibility Criteria

Sex
ALL
Age
50 Years - 74 Years
Healthy Volunteers
Not accepted

Interventions

  • Intermittent Hypoxic-Hyperoxic Training (3 days) — OTHER
    Three daily sessions using HYPO-OXY-1 (OXYTERRA) device
  • Intermittent Hypoxic-Hyperoxic Training (10 days) — OTHER
    Ten daily sessions using HYPO-OXY-1 (OXYTERRA) device
  • Normoxic gas breathing — OTHER
    Ten daily sessions of breathing gas mixture with constant O2 21%

Study Details

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 Dates

First listed
May 7, 2026
Start date
Oct 15, 2025
Status verified
May 2026
Primary completion
Jun 15, 2027
Completion
Dec 15, 2027

Study Design

Enrollment
250 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: Arm 1: Short Course IHHT (3 days)
    Participants receive 3 consecutive daily sessions of IHHT (24 minutes each, 3 cycles of 5-min hypoxia/3-min hyperoxia, target SpO2 80-85%)
  • Experimental: Arm 2: Long Course IHHT (10 days)
    Participants receive 10 daily sessions of IHHT (40 minutes each, 5 cycles of 5-min hypoxia/3-min hyperoxia, target SpO2 80-85%, excluding weekends and holidays)
  • Sham Comparator: Arm 3: Control
    Participants receive 10 daily sessions of breathing gas mixture with constant O2 21% for 40 minutes (excluding weekends and holidays)

Primary Outcome Measure

Change in fasting glucose level (mmol/L) from baseline to 30±3 days after intervention completion [ Time Frame: Baseline, day 30 ]

Central Contacts

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