Short versus long intermittent hypoxic-hyperoxic training for people with type 2 diabetes, including older adults
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
NA · National Medical Research Center for Therapy and Preventive Medicine · NCT07574333
This study will see if short (3-day) or longer (10-day) sessions of intermittent low-oxygen/high-oxygen breathing improve blood sugar control in people aged 50–74 with type 2 diabetes.
Quick facts
| Phase | NA |
|---|---|
| Study type | Interventional |
| Enrollment | 250 (estimated) |
| Ages | 50 Years to 74 Years |
| Sex | All |
| Sponsor | National Medical Research Center for Therapy and Preventive Medicine (other gov) |
| Locations | 1 site (Moscow) |
| Trial ID | NCT07574333 on ClinicalTrials.gov |
What this trial studies
This single-center randomized trial in Moscow will randomize adults aged 50–74 with type 2 diabetes to a 3-day IHHT course, a 10-day IHHT course, or a control gas-breathing group. Participants undergo supervised intermittent hypoxic-hyperoxic breathing sessions while the control group breathes a normoxic gas mixture. The primary outcomes are fasting glucose and HbA1c measured before and after the intervention. Secondary outcomes include cardiovascular measures, quality of life, cognitive tests, and biological age markers.
Who should consider this trial
Good fit: Adults 50–74 years with documented type 2 diabetes who are on stable therapy, able to follow the protocol, and can provide informed consent are suitable candidates.
Not a fit: People with type 1 diabetes, recent acute diabetic complications, uncontrolled severe hypertension, significant cardiovascular disease, major carotid stenosis, active infections, or chronic lung disease are excluded and unlikely to benefit from this intervention.
Why it matters
Potential benefit: If successful, IHHT could improve fasting glucose and HbA1c and may also provide benefits for cardiovascular health, cognition, quality of life, and biological aging in people with type 2 diabetes.
How similar studies have performed: Small pilot studies and preliminary reports have suggested possible cardiometabolic benefits of intermittent hypoxic-hyperoxic training, but robust randomized evidence in type 2 diabetes remains limited.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Moscow
- National Medical Research Center for Therapy and Preventive Medicine — Moscow, Russia (RECRUITING)
Study contacts
- Principal investigator: Oksana M Drapkina, MD, Prof. — National Medical Research Center for Therapy and Preventive Medicine
- Study coordinator: Mikhail G Chashchin, PhD
- Email: dr.chaschin@gmail.com
- Phone: +79774331118
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.
Conditions: Type 2 Diabetes Mellitus, Hyperglycemia, Metabolic Syndrome, Older Adults, Intermittent hypoxic-hyperoxic training, T2DM, Glycemic control, Elderly patients