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NCT Number: NCT07574333

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

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.

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Key information

Conditions

Type 2 Diabetes Mellitus (T2DM) Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Hyperglycemia Hyperinsulinism Insulin Resistance Metabolic Diseases Metabolic Syndrome Nutritional and Metabolic Diseases Older Adults (65 Years and Older)

Age range

50 year–74 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

National Medical Research Center for Therapy and Preventive Medicine

Moscow, Russia

Location status: Recruiting

Location contact

Oksana Drapkina

CONTACT

+7 (495) 212-07-13

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

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%

Primary outcomes

  1. Change in fasting glucose level (mmol/L) from baseline to 30±3 days after intervention completion

    Time frame: Baseline, day 30

    Fasting glucose will be measured after 8-12 hours of fasting using immunoturbidimetric method (Architect 8000C analyzer)

  2. Change in HbA1c (%) from baseline to 30±3 days after intervention completion

    Time frame: Baseline, day 30

    HbA1c will be measured using high-performance liquid chromatography (HPLC) on Lifotronic H8 analyzer

Secondary outcomes

  1. Change in Cardio-Ankle Vascular Index (CAVI)

    Time frame: Baseline, day 17-19, day 30

  2. Change in flow-mediated vasodilation (%)

    Time frame: Baseline, day 17-19, day 30 post-intervention

  3. Change in 24-hour ambulatory blood pressure

    Time frame: Baseline and 30±3 days post-intervention

  4. Change in quality of life by SF-36

    Time frame: Baseline, day 17-19, and 30±3 days post-intervention

    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.

  5. Change in cognitive function by MoCA scale

    Time frame: Baseline, day 17-19, and 30±3 days post-intervention

    Montreal Cognitive Assessment scores range from 0-30, with scores ≥26 considered normal cognitive function

  6. Change in anxiety and depression by HADS

    Time frame: Baseline, day 17-19, and 30±3 days post-intervention

    Hospital Anxiety and Depression Scale assesses anxiety and depression separately, each scored 0-21, with higher scores indicating greater symptom severity

  7. Change in biological age

    Time frame: Baseline and 30±3 days post-intervention

  8. Change in 6-minute walk test distance (meters)

    Time frame: Baseline and 30±3 days post-intervention

Study contacts

Contact information is provided by the study sponsor or research team.

Mikhail G Chashchin, PhD

CONTACT

[email protected]

+79774331118

Sponsors and collaborators

Lead sponsor

National Medical Research Center for Therapy and Preventive Medicine

Other Gov

Registry information

Official study title

A Single-Center Randomized Clinical Trial With Prospective Follow-up of the Efficacy and Safety of Short and Long Duration Intermittent Hypoxic-Hyperoxic Training in Patients With Type 2 Diabetes Mellitus Including Elderly Patients

Acronym: EFIR

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
May 7, 2026
Registry last updated
May 7, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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