Effects of Short and Long Courses of Intermittent Hypoxic-Hyperoxic Training in Patients With Type 2 Diabetes Including Elderly (EFIR)
4. maj 2026 opdateret af: 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.
Studieoversigt
Status
Rekruttering
Betingelser
Undersøgelsestype
Interventionel
Tilmelding (Anslået)
250
Fase
- Ikke anvendelig
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiekontakt
- Navn: Mikhail G Chashchin, PhD
- Telefonnummer: +79774331118
- E-mail: dr.chaschin@gmail.com
Studiesteder
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Moscow, Rusland
- Rekruttering
- National Medical Research Center for Therapy and Preventive Medicine
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Kontakt:
- Oksana Drapkina
- Telefonnummer: +7 (495) 212-07-13
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Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
- Voksen
- Ældre voksen
Tager imod sunde frivillige
Ingen
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Enkelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
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Eksperimentel: 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%)
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Three daily sessions using HYPO-OXY-1 (OXYTERRA) device
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Eksperimentel: 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)
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Ten daily sessions using HYPO-OXY-1 (OXYTERRA) device
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Sham-komparator: Arm 3: Control
Participants receive 10 daily sessions of breathing gas mixture with constant O2 21% for 40 minutes (excluding weekends and holidays)
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Ten daily sessions of breathing gas mixture with constant O2 21%
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Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Change in fasting glucose level (mmol/L) from baseline to 30±3 days after intervention completion
Tidsramme: Baseline, day 30
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Fasting glucose will be measured after 8-12 hours of fasting using immunoturbidimetric method (Architect 8000C analyzer)
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Baseline, day 30
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Change in HbA1c (%) from baseline to 30±3 days after intervention completion
Tidsramme: Baseline, day 30
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HbA1c will be measured using high-performance liquid chromatography (HPLC) on Lifotronic H8 analyzer
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Baseline, day 30
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Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
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Change in Cardio-Ankle Vascular Index (CAVI)
Tidsramme: Baseline, day 17-19, day 30
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Baseline, day 17-19, day 30
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Change in flow-mediated vasodilation (%)
Tidsramme: Baseline, day 17-19, day 30 post-intervention
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Baseline, day 17-19, day 30 post-intervention
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Change in 24-hour ambulatory blood pressure
Tidsramme: Baseline and 30±3 days post-intervention
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Baseline and 30±3 days post-intervention
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Change in quality of life by SF-36
Tidsramme: Baseline, day 17-19, and 30±3 days post-intervention
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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.
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Baseline, day 17-19, and 30±3 days post-intervention
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Change in cognitive function by MoCA scale
Tidsramme: Baseline, day 17-19, and 30±3 days post-intervention
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Montreal Cognitive Assessment scores range from 0-30, with scores ≥26 considered normal cognitive function
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Baseline, day 17-19, and 30±3 days post-intervention
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Change in anxiety and depression by HADS
Tidsramme: Baseline, day 17-19, and 30±3 days post-intervention
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Hospital Anxiety and Depression Scale assesses anxiety and depression separately, each scored 0-21, with higher scores indicating greater symptom severity
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Baseline, day 17-19, and 30±3 days post-intervention
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Change in biological age
Tidsramme: Baseline and 30±3 days post-intervention
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Baseline and 30±3 days post-intervention
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Change in 6-minute walk test distance (meters)
Tidsramme: Baseline and 30±3 days post-intervention
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Baseline and 30±3 days post-intervention
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Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Efterforskere
- Studiestol: Marina I Smirnova, PhD, National Medical Research Center for Therapy and Preventive Medicine
- Studiestol: Svetlana A Berns, MD, Prof., National Medical Research Center for Therapy and Preventive Medicine
- Ledende efterforsker: Oksana M Drapkina, MD, Prof., National Medical Research Center for Therapy and Preventive Medicine
- Studiestol: Alexandr Yu Gorshkov, PhD, National Medical Research Center for Therapy and Preventive Medicine
- Studiestol: Mikhail G Chashchin, PhD, National Medical Research Center for Therapy and Preventive Medicine
- Studiestol: Liubov Lifanova, PhD, National Medical Research Center for Therapy and Preventive Medicine
- Studiestol: Andrey I Korolev, PhD, National Medical Research Center for Therapy and Preventive Medicine
- Studiestol: Diana N Antipushina, PhD, National Medical Research Center for Therapy and Preventive Medicine
- Studiestol: Lidia N Ryuzhakova, PhD, National Medical Research Center for Therapy and Preventive Medicine
- Studiestol: Elena N Ignatikova, National Medical Research Center for Therapy and Preventive Medicine
- Studiestol: Svetlava Voinova, National Medical Research Center for Therapy and Preventive Medicine
- Studiestol: Olga Zhdanova, National Medical Research Center for Therapy and Preventive Medicine
- Studiestol: Ailina M Zhulaushinova, National Medical Research Center for Therapy and Preventive Medicine
- Studiestol: Alexandr V Emelyanov, National Medical Research Center for Therapy and Preventive Medicine
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Generelle publikationer
- 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.
- 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.
- 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.
- 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.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart (Faktiske)
15. oktober 2025
Primær færdiggørelse (Anslået)
15. juni 2027
Studieafslutning (Anslået)
15. december 2027
Datoer for studieregistrering
Først indsendt
21. februar 2026
Først indsendt, der opfyldte QC-kriterier
4. maj 2026
Først opslået (Faktiske)
7. maj 2026
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
7. maj 2026
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
4. maj 2026
Sidst verificeret
1. maj 2026
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
Andre undersøgelses-id-numre
- EFIR_0309_2025
Lægemiddel- og udstyrsoplysninger, undersøgelsesdokumenter
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