Recruiting

Effects of Short and Long Courses of Intermittent Hypoxic-Hyperoxic Training in Patients With Type 2 Diabetes Including Elderly

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…

ClinicalTrials.gov IDNCT07574333

PhaseNA

Enrollment250

SponsorNational Medical Research Center for Therapy and Preventive Medicine

Age50 Years

SexALL

I'm interested View official listing

Conditions studied

Type 2 Diabetes Mellitus (T2DM), Hyperglycemia, Metabolic Syndrome, Older Adults (65 Years and Older)

About this study

Interventions

Other: Intermittent Hypoxic-Hyperoxic Training (3 days) — Three daily sessions using HYPO-OXY-1 (OXYTERRA) device
Other: Intermittent Hypoxic-Hyperoxic Training (10 days) — Ten daily sessions using HYPO-OXY-1 (OXYTERRA) device
Other: Normoxic gas breathing — Ten daily sessions of breathing gas mixture with constant O2 21%

Primary outcomes

Change in fasting glucose level (mmol/L) from baseline to 30±3 days after intervention completion (Baseline, day 30)
Change in HbA1c (%) from baseline to 30±3 days after intervention completion (Baseline, day 30)

Eligibility information

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

Study locations

National Medical Research Center for Therapy and Preventive Medicine, Moscow, Russia

Before you participate: Varda Clinical is an independent discovery tool, not the study sponsor or a medical provider. Eligibility can only be determined by the official study team. Discuss potential risks and benefits with a qualified healthcare professional.

Source: ClinicalTrials.gov. Record last refreshed by Varda Clinical: 2026-09-29.