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Phase Not Applicable
Age: 50Years - 74Years
All Genders
ID07574333
A Single-Center Randomized Clinical Trial Evaluating Short and Long Intermittent Hypoxic-Hyperoxic Training Courses in Adults With Type 2 Diabetes Mellitus
Led by National Medical Research Center for Therapy and Preventive Medicine · Updated on 2026-05-07
250
Participants Needed
1
Research Sites
26 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
Researchers are evaluating the effectiveness and safety of short versus long courses of intermittent hypoxic-hyperoxic training (IHHT) in patients aged 50 to 74 years with type 2 diabetes. This single-center randomized controlled trial compares a 3-day IHHT course, a 10-day IHHT course, and a control group receiving a constant oxygen gas mixture. The primary focus is on changes in fasting glucose and HbA1c levels, with secondary measures including cardiovascular health, quality of life, cognitive function, and biological age. Participants are randomly assigned to one of three groups: the short course group receives three daily IHHT sessions lasting 24 minutes each with cycles of low and high oxygen levels; the long course group receives ten daily IHHT sessions lasting 40 minutes each excluding weekends and holidays; the control group receives ten daily sessions breathing a gas mixture with constant oxygen at 21% for 40 minutes excluding weekends and holidays. The IHHT sessions use the HYPO-OXY-1 (OXYTERRA) device targeting oxygen saturation levels between 80-85%. During the study, participants undergo assessments at baseline, during the intervention, and about 30 days after completing the sessions. These include blood tests for fasting glucose and HbA1c, cardiovascular measurements like the Cardio-Ankle Vascular Index and blood pressure monitoring, quality of life and cognitive function questionnaires, anxiety and depression scales, biological age evaluation, and a 6-minute walk test. Safety and adherence are monitored throughout the intervention and follow-up periods, with the total participation lasting over one month post-intervention.
CONDITIONS
Brief Title
Effects of Short and Long Courses of Intermittent Hypoxic-Hyperoxic Training in Patients With Type 2 Diabetes Including Elderly
Who Can Participate
Age: 50Years - 74Years
All Genders
Eligibility Criteria
You may qualify if you...
- Age 50 to 74 years inclusive
- Confirmed diagnosis of type 2 diabetes mellitus by medical documentation
- Stable treatment for diabetes and other chronic diseases for at least 4 weeks before enrollment
- Ability to follow the study protocol requirements
- Signed informed consent form
You will not qualify if you...
- Diagnosis of type 1 diabetes mellitus
- Acute diabetes complications within the last 6 months (e.g., 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 (systolic BP ≥180 mmHg and/or diastolic BP ≥110 mmHg)
- Acute cerebrovascular accident, myocardial infarction, surgery, or significant injuries within 6 months
- Internal carotid artery stenosis greater than 60% or symptomatic stenosis between 50-99%
- Chronic obstructive pulmonary disease or bronchial asthma
- Exacerbation or decompensation of chronic diseases within 1 month with elevated liver enzymes (ALT and/or AST more than 2-3 times upper normal limits)
- Congenital heart and major vessel abnormalities
- Implanted cardiac pacemaker
- Cancer with remission less than 5 years
- Mental illness, drug addiction, or alcohol dependence
- Pregnancy
- Inability to participate for the entire study period
AI-Screening
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Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 3 to 10 days excluding weekends and holidays
Participants undergo either 3 or 10 daily sessions of intermittent hypoxic-hyperoxic training, or 10 daily sessions of normoxic gas breathing as a control.
Daily visits for treatment sessions
Follow-up
Duration - Approximately 30 days after treatment completion
Participants are monitored for changes in glucose levels, vascular function, blood pressure, quality of life, cognitive function, and other health measures following treatment completion.
Visits at about 17-19 days and 30 days post-treatment
Trial Site Locations
Total: 1 location
1
National Medical Research Center for Therapy and Preventive Medicine
Moscow, Russia
Actively Recruiting
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Research Team
M
Mikhail G Chashchin, PhD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
SINGLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
3
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