Effects of Short and Long Courses of Intermittent Hypoxic-Hyperoxic Training in Patients With Type 2 Diabetes Including Elderly
Recruiting · NCT07574333 · Interventional (participants receive a specific treatment)
View the official record on ClinicalTrials.gov →Interventions studied
Intermittent Hypoxic-Hyperoxic Training (10 days)Intermittent Hypoxic-Hyperoxic Training (3 days)Normoxic gas breathing
What this trial is about
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.
Who can take part
Age range
50 Years to 74 Years
Sex
All (male and female)
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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 it is running
1 location listed.
- National Medical Research Center for Therapy and Preventive Medicine - Moscow, Russia