An interventional study of Intermittent Hypoxic-Hyperoxic Training (3 days) and Intermittent Hypoxic-Hyperoxic Training (10 days) in Type 2 Diabetes Mellitus (T2DM), Hyperglycemia and Metabolic Syndrome, sponsored by National Medical Research Center for Therapy and Preventive Medicine. Recruiting at 1 site in Russia. Open to participants aged 50 Years to 74 Years. Per ClinicalTrials.gov, last updated 2026-05-07.
Sponsored by National Medical Research Center for Therapy and Preventive Medicine · Not applicable, Interventional, and Treatment
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.
10,371 studies on the registry are indexed under Diabetes Mellitus, Type 2; 1,406 are open to participants now.
This study's planned enrollment of 250 is above the median of 80 across 8,350 interventional studies indexed under Diabetes Mellitus, Type 2.
Browse Diabetes Mellitus, Type 2 studies →National Medical Research Center for Therapy and Preventive Medicine is the lead sponsor of 29 studies on the registry; 11 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Clinically significant
Judged by the study doctor to matter for your health or for the study. It is a doctor’s decision, so ask the study team if you are unsure whether something counts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
COPD
Chronic obstructive pulmonary disease: long-term lung disease that makes it hard to breathe out, including emphysema and chronic bronchitis.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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)
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)
Participants receive 10 daily sessions of breathing gas mixture with constant O2 21% for 40 minutes (excluding weekends and holidays)
Other: Normoxic gas breathing
Three daily sessions using HYPO-OXY-1 (OXYTERRA) device
Ten daily sessions using HYPO-OXY-1 (OXYTERRA) device
Ten daily sessions of breathing gas mixture with constant O2 21%
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)
Time frame: 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
Time frame: Baseline, day 30
Change in Cardio-Ankle Vascular Index (CAVI)
Time frame: Baseline, day 17-19, day 30
Change in flow-mediated vasodilation (%)
Time frame: Baseline, day 17-19, day 30 post-intervention
Change in 24-hour ambulatory blood pressure
Time frame: 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.
Time frame: 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
Time frame: 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
Time frame: Baseline, day 17-19, and 30±3 days post-intervention
Change in biological age
Time frame: Baseline and 30±3 days post-intervention
Change in 6-minute walk test distance (meters)
Time frame: Baseline and 30±3 days post-intervention
Started Oct 2025 (actual). Primary completion is estimated for Jun 2027, 20 months after the start.
Of 2,066 non-industry interventional studies with no phase under Diabetes Mellitus, Type 2, half reached primary completion within 21 months of starting (the median), counting those still running; a quarter within 10 and three quarters within 40. This study's planned 20 months is close to that.
Counting every sponsor, half of 2,243 studies reached it within 21 months; a quarter within 10 and three quarters within 39.
How these figures are worked out, and which studies are left out of them.
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National Medical Research Center for Therapy and Preventive Medicine