Effects of Short and Long Courses of Intermittent Hypoxic-Hyperoxic Training in Patients With Type 2 Diabetes Including Elderly (EFIR)
4. mai 2026 oppdatert av: 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.
Studieoversikt
Status
Rekruttering
Forhold
Studietype
Intervensjonell
Registrering (Antatt)
250
Fase
- Ikke aktuelt
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiekontakt
- Navn: Mikhail G Chashchin, PhD
- Telefonnummer: +79774331118
- E-post: dr.chaschin@gmail.com
Studiesteder
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Moscow, Russland
- Rekruttering
- National Medical Research Center for therapy and preventive medicine
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Ta kontakt med:
- Oksana Drapkina
- Telefonnummer: +7 (495) 212-07-13
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Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
- Voksen
- Eldre voksen
Tar imot friske frivillige
Nei
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Enkelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
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Eksperimentell: 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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Eksperimentell: 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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Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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 |
Tiltaksbeskrivelse |
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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Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Etterforskere
- 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
- Hovedetterforsker: 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
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Generelle publikasjoner
- 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.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart (Faktiske)
15. oktober 2025
Primær fullføring (Antatt)
15. juni 2027
Studiet fullført (Antatt)
15. desember 2027
Datoer for studieregistrering
Først innsendt
21. februar 2026
Først innsendt som oppfylte QC-kriteriene
4. mai 2026
Først lagt ut (Faktiske)
7. mai 2026
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
7. mai 2026
Siste oppdatering sendt inn som oppfylte QC-kriteriene
4. mai 2026
Sist bekreftet
1. mai 2026
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
Andre studie-ID-numre
- EFIR_0309_2025
Legemiddel- og utstyrsinformasjon, studiedokumenter
Studerer et amerikansk FDA-regulert medikamentprodukt
Nei
Studerer et amerikansk FDA-regulert enhetsprodukt
Nei
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