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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
Location: See location...
Intervention Type: Other
Study Type: Interventional
Study Phase: Not Applicable
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.

Eligibility
Participation Requirements
Sex: All
Minimum Age: 50
Maximum Age: 74
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Russian Federation
National Medical Research Center for Therapy and Preventive Medicine
RECRUITING
Moscow
Contact Information
Primary
Mikhail G Chashchin, PhD
dr.chaschin@gmail.com
+79774331118
Time Frame
Start Date: 2025-10-15
Estimated Completion Date: 2027-12-15
Participants
Target number of participants: 250
Treatments
Experimental: Arm 1: Short Course IHHT (3 days)
Participants receive 3 consecutive daily sessions of IHHT (24 minutes each, 3 cycles of 5-min hypoxia/3-min hyperoxia, target SpO2 80-85%)
Experimental: Arm 2: Long Course IHHT (10 days)
Participants receive 10 daily sessions of IHHT (40 minutes each, 5 cycles of 5-min hypoxia/3-min hyperoxia, target SpO2 80-85%, excluding weekends and holidays)
Sham_comparator: Arm 3: Control
Participants receive 10 daily sessions of breathing gas mixture with constant O2 21% for 40 minutes (excluding weekends and holidays)
Sponsors
Leads: National Medical Research Center for Therapy and Preventive Medicine

This content was sourced from clinicaltrials.gov

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