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Type 2 Diabetes Mellitus (T2DM)EFIRNCT07574333

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

A study testing Intermittent Hypoxic-Hyperoxic Training (3 days), Intermittent Hypoxic-Hyperoxic Training (10 days) and Normoxic gas breathing in people with Type 2 Diabetes Mellitus (T2DM) and Hyperglycemia, run by National Medical Research Center for Therapy and Preventive Medicine at 1 site in Russia.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial 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. Read more about this study

Who is it for?
Ages 50 to 74 years
What is being tested?
Intermittent Hypoxic-Hyperoxic Training (3 days), Intermittent Hypoxic-Hyperoxic Training (10 days) and Normoxic gas breathing
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
250 participants
Where
1 siteRussia
Study dates
15 Oct 2025to 15 Dec 2027
Phase
Interventional
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 50 to 74 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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
Show all 15Show fewer
  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Mikhail G Chashchin, PhD contact

+79774331118

dr.chaschin@gmail.com

Russia1 site, 1 recruiting

  • National Medical Research Center for Therapy and Preventive Medicine

    Moscow

    Oksana Drapkina, +7 (495) 212-07-13

    Recruiting

Other trials in Russia

About this study

Official 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

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.

Being tested
Intermittent Hypoxic-Hyperoxic Training (3 days), Intermittent Hypoxic-Hyperoxic Training (10 days), Normoxic gas breathing
Keywords
Intermittent hypoxic-hyperoxic training, T2DM, Type 2 Diabetes Mellitus, Glycemic control, Elderly patients, Non-pharmacological intervention, Hypoxia conditioning
Medical subject headings
Diabetes Mellitus, Type 2, Hyperglycemia, Metabolic Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • 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 breathingOther

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

Study groups in NCT07574333
Study groupRoleWhat they receive
Arm 1: Short Course IHHT (3 days)ExperimentalParticipants receive 3 consecutive daily sessions of IHHT (24 minutes each, 3 cycles of 5-min hypoxia/3-min hyperoxia, target SpO2 80-85%)
Receives: Other: Intermittent Hypoxic-Hyperoxic Training (3 days)
Arm 2: Long Course IHHT (10 days)ExperimentalParticipants 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)
Receives: Other: Intermittent Hypoxic-Hyperoxic Training (10 days)
Arm 3: ControlSham comparatorParticipants receive 10 daily sessions of breathing gas mixture with constant O2 21% for 40 minutes (excluding weekends and holidays)
Receives: Other: Normoxic gas breathing

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Change 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)

    Measured: Baseline, day 30

  2. 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

    Measured: Baseline, day 30

Secondary outcomes (8)

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

    Measured: Baseline, day 17-19, day 30

  2. Change in flow-mediated vasodilation (%)

    Measured: Baseline, day 17-19, day 30 post-intervention

  3. Change in 24-hour ambulatory blood pressure

    Measured: Baseline and 30±3 days post-intervention

  4. 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.

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

  5. Change in cognitive function by MoCA scale

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

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

  6. 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

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

  7. Change in biological age

    Measured: Baseline and 30±3 days post-intervention

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

    Measured: Baseline and 30±3 days post-intervention

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted7 May 2026
  2. Study start15 Oct 2025
  3. Primary completion15 Jun 2027 (estimated)
  4. Study completion15 Dec 2027 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase N/A
Primary purpose
Treatment
Allocation
Randomised
Intervention model
Parallel groups
Model description
Participants are randomly assigned to one of three parallel groups: short-course IHHT (3 days), long-course IHHT (10 days), or control group (normoxic breathing for 10 days). All groups receive their assigned intervention and are followed prospectively for 30±3 days post-intervention.
Masking
Single blind
Who is masked
Participant
Enrolment
250 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT07574333
Sponsor's protocol ID
EFIR_0309_2025
Acronym
EFIR
Status last verified
May 2026
First submitted
21 Feb 2026
Last updated
7 May 2026
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No

Publications

  • Holland AE, Spruit MA, Troosters T, Puhan MA, Pepin V, Saey D, McCormack MC, Carlin BW, Sciurba FC, Pitta F, Wanger J, MacIntyre N, Kaminsky DA, Culver BH, Revill SM, Hernandes NA, Andrianopoulos V, Camillo CA, Mitchell KE, Lee AL, Hill CJ, Singh SJ. An official European Respiratory Society/American Thoracic Society technical standard: field walking tests in chronic respiratory disease. Eur Respir J. 2014 Dec;44(6):1428-46. doi: 10.1183/09031936.00150314. Epub 2014 Oct 30.

    PubMed 25359355

  • Levine ME, Lu AT, Quach A, Chen BH, Assimes TL, Bandinelli S, Hou L, Baccarelli AA, Stewart JD, Li Y, Whitsel EA, Wilson JG, Reiner AP, Aviv A, Lohman K, Liu Y, Ferrucci L, Horvath S. An epigenetic biomarker of aging for lifespan and healthspan. Aging (Albany NY). 2018 Apr 18;10(4):573-591. doi: 10.18632/aging.101414.

    PubMed 29676998

  • Moore HM, Kelly A, Jewell SD, McShane LM, Clark DP, Greenspan R, Hainaut P, Hayes DF, Kim P, Mansfield E, Potapova O, Riegman P, Rubinstein Y, Seijo E, Somiari S, Watson P, Weier HU, Zhu C, Vaught J. Biospecimen Reporting for Improved Study Quality. Biopreserv Biobank. 2011 Apr;9(1):57-70. doi: 10.1089/bio.2010.0036.

    PubMed 21826252

  • Chernyavsky M.A., Irtyuga O.B., Yanishevsky S.N., Alieva A.S., Samochernykh K.A., Abramov K.B., Vavilova T.V., Lukyanchikov V.A., Kurapeev D.I., Vanyurkin A.G., Chernova D.V., Shelukhanov N.K., Kozlyonok А.V., Kavteladze Z.A., Malevanny M.V., Vinogradov R.A., Khafizov T.N., Ivanova G.E., Zhukovskaya N.V., Fokin A.A., Ignatiev I.M., Karpenko A.A., Ignatenko P.V., Astapov D.A., Semenov V.Yu., Porkhanov V.A., Krylov V.V., Usachev D.Yu., Svetlikov A.V., Alekyan B.G., Akchurin R.S., Chernyavsky A.M., Konradi A.O., Shlyakhto E.V. Russian consensus statement on the diagnosis and treatment of patients with carotid stenosis. Russian Journal of Cardiology. 2022;27(11):5284. (In Russ.) https://doi.org/10.15829/1560-4071-2022-5284

  • Dedov II, Shestakova MV, Sukhareva OY, editors. Standards of specialized diabetes care. 12th edition. Moscow; 2025

  • Serebrovska TV, Grib ON, Portnichenko VI, Serebrovska ZO, Egorov E, Shatylo VB. Intermittent Hypoxia/Hyperoxia Versus Intermittent Hypoxia/Normoxia: Comparative Study in Prediabetes. High Alt Med Biol. 2019 Dec;20(4):383-391. doi: 10.1089/ham.2019.0053. Epub 2019 Oct 7.

    PubMed 31589074

Questions about this trial

What is this clinical trial studying?

A study testing Intermittent Hypoxic-Hyperoxic Training (3 days), Intermittent Hypoxic-Hyperoxic Training (10 days) and Normoxic gas breathing in people with Type 2 Diabetes Mellitus (T2DM) and Hyperglycemia, run by National Medical Research Center for Therapy and Preventive Medicine at 1 site in Russia.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 5 inclusion and 15 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 7 May 2026. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in Russia. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Mikhail G Chashchin, PhD (+79774331118, dr.chaschin@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Change in fasting glucose level (mmol/L) from baseline to 30±3 days after intervention completion (time frame: Baseline, day 30). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT07574333, which also lists 6 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2026.

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