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

Summary

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.

Conditions

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

Interventions

OTHER

Intermittent Hypoxic-Hyperoxic Training (3 days)

Three daily sessions using HYPO-OXY-1 (OXYTERRA) device

OTHER

Intermittent Hypoxic-Hyperoxic Training (10 days)

Ten daily sessions using HYPO-OXY-1 (OXYTERRA) device

OTHER

Normoxic gas breathing

Ten daily sessions of breathing gas mixture with constant O2 21%

Sponsors & Collaborators

• National Medical Research Center for Therapy and Preventive Medicine

  lead OTHER_GOV

Principal Investigators

• Marina I Smirnova, PhD · National Medical Research Center for Therapy and Preventive Medicine

• Svetlana A Berns, MD, Prof. · National Medical Research Center for Therapy and Preventive Medicine

• Oksana M Drapkina, MD, Prof. · National Medical Research Center for Therapy and Preventive Medicine

• Alexandr Yu Gorshkov, PhD · National Medical Research Center for Therapy and Preventive Medicine

• Mikhail G Chashchin, PhD · National Medical Research Center for Therapy and Preventive Medicine

• Liubov Lifanova, PhD · National Medical Research Center for Therapy and Preventive Medicine

• Andrey I Korolev, PhD · National Medical Research Center for Therapy and Preventive Medicine

• Diana N Antipushina, PhD · National Medical Research Center for Therapy and Preventive Medicine

• Lidia N Ryuzhakova, PhD · National Medical Research Center for Therapy and Preventive Medicine

• Elena N Ignatikova · National Medical Research Center for Therapy and Preventive Medicine

• Svetlava Voinova · National Medical Research Center for Therapy and Preventive Medicine

• Olga Zhdanova · National Medical Research Center for Therapy and Preventive Medicine

• Ailina M Zhulaushinova · National Medical Research Center for Therapy and Preventive Medicine

• Alexandr V Emelyanov · National Medical Research Center for Therapy and Preventive Medicine

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

SINGLE

Model

PARALLEL

Eligibility

Min Age

50 Years

Max Age

74 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2025-10-15

Primary Completion

2027-06-15

Completion

2027-12-15

Countries

• Russia

Study Locations