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

ConditionsType 2 Diabetes Mellitus (T2DM)HyperglycemiaMetabolic SyndromeOlder Adults (65 Years and Older)
Trial statusRecruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age50-74
SponsorNational Medical Research Center for Therapy and Preventive Medicine

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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

Disqualifiers

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

Trial design

Design model

Parallel

Treatments tested in this trial

  • Intermittent Hypoxic-Hyperoxic Training (3 days)

    Other intervention

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

  • Intermittent Hypoxic-Hyperoxic Training (10 days)

    Other intervention

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

  • Normoxic gas breathing

    Other intervention

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

Treatment groups

250 Participants
are divided into 3 treatment groups
Group A: Arm 1: Short Course IHHT (3 days)Experimental treatment 1 intervention
Group B: Arm 2: Long Course IHHT (10 days)Experimental treatment 1 intervention
Group C: Arm 3: ControlSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

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

Fasting glucose will be measured after 8-12 hours of fasting using immunoturbidimetric method (Architect 8000C analyzer)

Time frame
Baseline, day 30
2

Change in HbA1c (%) from baseline to 30±3 days after intervention completion

HbA1c will be measured using high-performance liquid chromatography (HPLC) on Lifotronic H8 analyzer

Time frame
Baseline, day 30

Secondary outcomes

1

Change in Cardio-Ankle Vascular Index (CAVI)

Time frame
Baseline, day 17-19, day 30
2

Change in flow-mediated vasodilation (%)

Time frame
Baseline, day 17-19, day 30 post-intervention
3

Change in 24-hour ambulatory blood pressure

Time frame
Baseline and 30±3 days post-intervention
4

Change in quality of life by SF-36

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.

Time frame
Baseline, day 17-19, and 30±3 days post-intervention

Other outcomes

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

National Medical Research Center for Therapy and Preventive Medicine

Lead sponsor

Source ClinicalTrials.gov
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