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

NCT07574333 | Recruiting

• 1 other identifier: EFIR_0309_2025
• Study Type: interventional
• Target: 250
• Locations: 1 country
• Sites: 1

Brief 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)

Keywords

Intermittent hypoxic-hyperoxic training; T2DM; Type 2 Diabetes Mellitus; Glycemic control; Elderly patients; Non-pharmacological intervention; Hypoxia conditioning

Outcome Measures

Primary Outcomes (2)

• 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

Secondary Outcomes (8)

• 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

• Change in 24-hour ambulatory blood pressure

  Baseline and 30±3 days post-intervention

• Change in quality of life by SF-36

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

• Change in cognitive function by MoCA scale

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

Study Arms (3)

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%)

Other: Intermittent Hypoxic-Hyperoxic Training (3 days)

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)

Other: Intermittent Hypoxic-Hyperoxic Training (10 days)

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)

Other: Normoxic gas breathing

Interventions

Intermittent Hypoxic-Hyperoxic Training (3 days) OTHER

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

Arm 1: Short Course IHHT (3 days)

Intermittent Hypoxic-Hyperoxic Training (10 days) OTHER

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

Arm 2: Long Course IHHT (10 days)

Normoxic gas breathing OTHER

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

Arm 3: Control

Eligibility Criteria

• Age: 50 Years - 74 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• National Medical Research Center for Therapy and Preventive Medicine: lead

Study Sites (1)

National Medical Research Center for Therapy and Preventive Medicine

Moscow, Russia

RECRUITING

Related Publications (6)

• 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.

  PMID: 25359355 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.

  PMID: 29676998 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.

  PMID: 21826252 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

  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.

  PMID: 31589074 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Hyperglycemia; Metabolic Syndrome

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Insulin Resistance; Hyperinsulinism

Study Officials

• 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

• 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

Central Study Contacts

Mikhail G Chashchin, PhD

CONTACT

+79774331118; dr.chaschin@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: 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.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: February 21, 2026
• First Posted: May 7, 2026
• Study Start: October 15, 2025
• Primary Completion (Estimated): June 15, 2027
• Study Completion (Estimated): December 15, 2027
• Last Updated: May 7, 2026

Record last verified: 2026-05

Locations

RU (1)