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
Trial Snapshot
- Phase
- Not Applicable
- Status
- Recruiting
- Enrollment
- 250
- Locations
- 1
Study Overview
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.
Study Design
- Study Type
- Interventional
- Allocation
- Randomized
- Intervention Model
- Parallel
- Primary Purpose
- Treatment
- Masking
- Single (Participant)
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.
Eligibility Criteria
- Ages
- 50 Years to 74 Years (Adult, Older Adult)
- Sex
- All
- Accepts Healthy Volunteers
- No
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