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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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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Arm 1: Short Course IHHT (3 days) | Experimental | Participants receive 3 consecutive daily sessions of IHHT (24 minutes each, 3 cycles of 5-min hypoxia/3-min hyperoxia, target SpO2 80-85%) |
|
| Arm 2: Long Course IHHT (10 days) | Experimental | 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) |
|
| Arm 3: Control | Sham Comparator | Participants receive 10 daily sessions of breathing gas mixture with constant O2 21% for 40 minutes (excluding weekends and holidays) |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intermittent Hypoxic-Hyperoxic Training (3 days) | Other | Three daily sessions using HYPO-OXY-1 (OXYTERRA) device |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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) | Baseline, day 30 |
| 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 | Baseline, day 30 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in Cardio-Ankle Vascular Index (CAVI) | Baseline, day 17-19, day 30 | |
| Change in flow-mediated vasodilation (%) | Baseline, day 17-19, day 30 post-intervention | |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Mikhail G Chashchin, PhD | Contact | +79774331118 | dr.chaschin@gmail.com |
| Name | Affiliation | Role |
|---|---|---|
| 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 | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| National Medical Research Center for Therapy and Preventive Medicine | Recruiting | Moscow | Russia |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 25359355 | Background | 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. | |
| 29676998 |
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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.
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Participants in Groups 2 (10-day IHHT) and 3 (control/sham) are blinded to their group assignment and do not know whether they are receiving active IHHT or breathing normoxic gas mixture (21% O2). Group 1 (3-day IHHT) participants are aware of their intervention due to the different duration. All interventions are conducted in separate rooms with identical equipment. Medical personnel conducting the interventions are not blinded.
| 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% |
|
| Change in 24-hour ambulatory blood pressure |
| Baseline and 30±3 days post-intervention |
| 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. | Baseline, day 17-19, and 30±3 days post-intervention |
| Change in cognitive function by MoCA scale | 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 | 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 | Baseline and 30±3 days post-intervention |
| Change in 6-minute walk test distance (meters) | Baseline and 30±3 days post-intervention |
| Oksana M Drapkina, MD, Prof. | National Medical Research Center for Therapy and Preventive Medicine | Principal Investigator |
| 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 | Study Chair |
| Background |
| 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. |
| 21826252 | Background | 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. |
| Background | 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 |
| Background | Dedov II, Shestakova MV, Sukhareva OY, editors. Standards of specialized diabetes care. 12th edition. Moscow; 2025 |
| 31589074 | Background | 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. |
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D006943 | Hyperglycemia |
| D024821 | Metabolic Syndrome |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D007333 | Insulin Resistance |
| D006946 | Hyperinsulinism |
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