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

May 4, 2026 updated by: National Medical Research Center for Therapy and Preventive Medicine

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

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 Overview

Status

Recruiting

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Estimated)

250

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Russia
      • Moscow, Russia
        • Recruiting
        • National Medical Research Center for Therapy and Preventive Medicine
        • Contact:
          • Oksana Drapkina
          • Phone Number: +7 (495) 212-07-13

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Single

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
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%)
Other: Intermittent Hypoxic-Hyperoxic Training (3 days)
Three daily sessions using HYPO-OXY-1 (OXYTERRA) device
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)
Other: Intermittent Hypoxic-Hyperoxic Training (10 days)
Ten daily sessions using HYPO-OXY-1 (OXYTERRA) device
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)
Other: Normoxic gas breathing
Ten daily sessions of breathing gas mixture with constant O2 21%

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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)
Baseline, day 30
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
Baseline, day 30

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Change in Cardio-Ankle Vascular Index (CAVI)
Time Frame: Baseline, day 17-19, day 30
Baseline, day 17-19, day 30
Change in flow-mediated vasodilation (%)
Time Frame: Baseline, day 17-19, day 30 post-intervention
Baseline, day 17-19, day 30 post-intervention
Change in 24-hour ambulatory blood pressure
Time Frame: Baseline and 30±3 days post-intervention
Baseline and 30±3 days post-intervention
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.
Baseline, day 17-19, and 30±3 days post-intervention
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
Baseline, day 17-19, and 30±3 days post-intervention
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
Baseline, day 17-19, and 30±3 days post-intervention
Change in biological age
Time Frame: Baseline and 30±3 days post-intervention
Baseline and 30±3 days post-intervention
Change in 6-minute walk test distance (meters)
Time Frame: Baseline and 30±3 days post-intervention
Baseline and 30±3 days post-intervention

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

National Medical Research Center for Therapy and Preventive Medicine

Investigators

  • Study Chair: Marina I Smirnova, PhD, National Medical Research Center for Therapy and Preventive Medicine
  • Study Chair: Svetlana A Berns, MD, Prof., National Medical Research Center for Therapy and Preventive Medicine
  • Principal Investigator: Oksana M Drapkina, MD, Prof., National Medical Research Center for Therapy and Preventive Medicine
  • Study Chair: Alexandr Yu Gorshkov, PhD, National Medical Research Center for Therapy and Preventive Medicine
  • Study Chair: Mikhail G Chashchin, PhD, National Medical Research Center for Therapy and Preventive Medicine
  • Study Chair: Liubov Lifanova, PhD, National Medical Research Center for Therapy and Preventive Medicine
  • Study Chair: Andrey I Korolev, PhD, National Medical Research Center for Therapy and Preventive Medicine
  • Study Chair: Diana N Antipushina, PhD, National Medical Research Center for Therapy and Preventive Medicine
  • Study Chair: Lidia N Ryuzhakova, PhD, National Medical Research Center for Therapy and Preventive Medicine
  • Study Chair: Elena N Ignatikova, National Medical Research Center for Therapy and Preventive Medicine
  • Study Chair: Svetlava Voinova, National Medical Research Center for Therapy and Preventive Medicine
  • Study Chair: Olga Zhdanova, National Medical Research Center for Therapy and Preventive Medicine
  • Study Chair: Ailina M Zhulaushinova, National Medical Research Center for Therapy and Preventive Medicine
  • Study Chair: Alexandr V Emelyanov, National Medical Research Center for Therapy and Preventive Medicine

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 15, 2025

Primary Completion (Estimated)

June 15, 2027

Study Completion (Estimated)

December 15, 2027

Study Registration Dates

First Submitted

February 21, 2026

First Submitted That Met QC Criteria

May 4, 2026

First Posted (Actual)

May 7, 2026

Study Record Updates

Last Update Posted (Actual)

May 7, 2026

Last Update Submitted That Met QC Criteria

May 4, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • EFIR_0309_2025

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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