Effects of Short and Long Courses of Intermittent Hypoxic-Hyperoxic Training in Patients With Type 2 Diabetes Including Elderly (EFIR)
4 maj 2026 uppdaterad 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.
Studieöversikt
Status
Rekrytering
Betingelser
Studietyp
Interventionell
Inskrivning (Beräknad)
250
Fas
- Inte tillämpbar
Kontakter och platser
Det här avsnittet innehåller kontaktuppgifter för dem som genomför studien och information om var denna studie genomförs.
Studiekontakt
- Namn: Mikhail G Chashchin, PhD
- Telefonnummer: +79774331118
- E-post: dr.chaschin@gmail.com
Studieorter
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Moscow, Ryssland
- Rekrytering
- 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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Deltagandekriterier
Forskare letar efter personer som passar en viss beskrivning, så kallade behörighetskriterier. Några exempel på dessa kriterier är en persons allmänna hälsotillstånd eller tidigare behandlingar.
Urvalskriterier
Åldrar som är berättigade till studier
- Vuxen
- Äldre vuxen
Tar emot friska volontärer
Nej
Beskrivning
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
Det här avsnittet ger detaljer om studieplanen, inklusive hur studien är utformad och vad studien mäter.
Hur är studien utformad?
Designdetaljer
- Primärt syfte: Behandling
- Tilldelning: Randomiserad
- Interventionsmodell: Parallellt uppdrag
- Maskning: Enda
Vapen och interventioner
Deltagargrupp / Arm |
Intervention / Behandling |
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Experimentell: 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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Experimentell: 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 Comparator: 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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Vad mäter studien?
Primära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
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Change in fasting glucose level (mmol/L) from baseline to 30±3 days after intervention completion
Tidsram: 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
Tidsram: 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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Sekundära resultatmått
Resultatmått |
Åtgärdsbeskrivning |
Tidsram |
|---|---|---|
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Change in Cardio-Ankle Vascular Index (CAVI)
Tidsram: 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 (%)
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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
Tidsram: 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)
Tidsram: Baseline and 30±3 days post-intervention
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Baseline and 30±3 days post-intervention
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Samarbetspartners och utredare
Det är här du hittar personer och organisationer som är involverade i denna studie.
Utredare
- 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
- Huvudutredare: 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 och användbara länkar
Den som ansvarar för att lägga in information om studien tillhandahåller frivilligt dessa publikationer. Dessa kan handla om allt som har med studien att göra.
Allmänna 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.
Studieavstämningsdatum
Dessa datum spårar framstegen för inlämningar av studieposter och sammanfattande resultat till ClinicalTrials.gov. Studieposter och rapporterade resultat granskas av National Library of Medicine (NLM) för att säkerställa att de uppfyller specifika kvalitetskontrollstandarder innan de publiceras på den offentliga webbplatsen.
Studera stora datum
Studiestart (Faktisk)
15 oktober 2025
Primärt slutförande (Beräknad)
15 juni 2027
Avslutad studie (Beräknad)
15 december 2027
Studieregistreringsdatum
Först inskickad
21 februari 2026
Först inskickad som uppfyllde QC-kriterierna
4 maj 2026
Första postat (Faktisk)
7 maj 2026
Uppdateringar av studier
Senaste uppdatering publicerad (Faktisk)
7 maj 2026
Senaste inskickade uppdateringen som uppfyllde QC-kriterierna
4 maj 2026
Senast verifierad
1 maj 2026
Mer information
Termer relaterade till denna studie
Nyckelord
Ytterligare relevanta MeSH-villkor
Andra studie-ID-nummer
- EFIR_0309_2025
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