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

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

Status

Recruiting

Phases

Unknown

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT07574333

Acronym

EFIR

Enrollment

250

Registered

2026-05-07

Start date

2025-10-15

Completion date

2027-12-15

Last updated

2026-05-07

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Keywords

Intermittent hypoxic-hyperoxic training, T2DM, Type 2 Diabetes Mellitus, Glycemic control, Elderly patients, Non-pharmacological intervention, Hypoxia conditioning

Brief summary

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.

Interventions

OTHERIntermittent Hypoxic-Hyperoxic Training (3 days)

Three daily sessions using HYPO-OXY-1 (OXYTERRA) device

OTHERIntermittent Hypoxic-Hyperoxic Training (10 days)

Ten daily sessions using HYPO-OXY-1 (OXYTERRA) device

OTHERNormoxic gas breathing

Ten daily sessions of breathing gas mixture with constant O2 21%

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

SINGLE (Subject)

Masking description

Participants in Groups 2 (10-day IHHT) and 3 (control/sham) are blinded to their group assignment and do not know whether they are receiving active IHHT or breathing normoxic gas mixture (21% O2). Group 1 (3-day IHHT) participants are aware of their intervention due to the different duration. All interventions are conducted in separate rooms with identical equipment. Medical personnel conducting the interventions are not blinded.

Intervention model description

Participants are randomly assigned to one of three parallel groups: short-course IHHT (3 days), long-course IHHT (10 days), or control group (normoxic breathing for 10 days). All groups receive their assigned intervention and are followed prospectively for 30±3 days post-intervention.

Eligibility

Sex/Gender

ALL

Age

50 Years to 74 Years

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
Change in fasting glucose level (mmol/L) from baseline to 30±3 days after intervention completion	Baseline, day 30	Fasting glucose will be measured after 8-12 hours of fasting using immunoturbidimetric method (Architect 8000C analyzer)
Change in HbA1c (%) from baseline to 30±3 days after intervention completion	Baseline, day 30	HbA1c will be measured using high-performance liquid chromatography (HPLC) on Lifotronic H8 analyzer

Secondary

Measure	Time frame	Description
Change in Cardio-Ankle Vascular Index (CAVI)	Baseline, day 17-19, day 30	—
Change in flow-mediated vasodilation (%)	Baseline, day 17-19, day 30 post-intervention	—
Change in 24-hour ambulatory blood pressure	Baseline and 30±3 days post-intervention	—
Change in quality of life by SF-36	Baseline, day 17-19, and 30±3 days post-intervention	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.
Change in cognitive function by MoCA scale	Baseline, day 17-19, and 30±3 days post-intervention	Montreal Cognitive Assessment scores range from 0-30, with scores ≥26 considered normal cognitive function
Change in anxiety and depression by HADS	Baseline, day 17-19, and 30±3 days post-intervention	Hospital Anxiety and Depression Scale assesses anxiety and depression separately, each scored 0-21, with higher scores indicating greater symptom severity
Change in biological age	Baseline and 30±3 days post-intervention	—
Change in 6-minute walk test distance (meters)	Baseline and 30±3 days post-intervention	—

Countries

Russia