Effects of High-Resistance Inspiratory Muscle Strength Training on Cardiorenal and Vascular Function in Youth and Young Adults With Type 2 Diabetes

Part of paid clinical trials in Seattle, Washington.

Sponsor
Seattle Children's Hospital
Study ID
NCT06936670
Status
Recruiting
Apply to this trial

Conditions

  • Diabetes Mellitus Type 2

Eligibility Criteria

Sex
ALL
Age
14 Years - 40 Years
Healthy Volunteers
Not accepted

Interventions

  • Inspiratory Muscle Strength Training (IMST) — DEVICE
    A novel form of physical training that uses the diaphragm and accessory respiratory muscles to repeatedly inhale against resistance using a handheld device, generating large negative intrathoracic pressures. The device can be set to different levels of resistance, meaning the intervention and sham groups will undergo the same training, but at 75% and 15% of their maximal inspiratory pressure respectively.
  • Sham Training — DEVICE
    The same training regiment but at much lower resistance, offering little to strength training impact.

Study Details

High-resistance, short-duration inspiratory muscle strength training (IMST) is a novel lifestyle intervention involving 30 inhalations against a resistive load which requires only \~5 min/day and is thus ideal for youth with T2D (Y-T2D). Investigators seek to 1: assess changes in casual and 24-hr SBP, endothelial function, and arterial stiffness after 3 months of IMST vs. sham training in Y-T2D, 2: Define changes in eGFR andalbuminuria after 3 months of IMST vs. sham in Y-T2D, 3: Interrogate mechanisms of IMST by translational assessments of NO bioavailability, endothelial NO synthase (eNOS) activation, and ROS/oxidative stress, and determine the role of circulating factors.

Key Dates

Start date
Apr 30, 2025
Status verified
Jun 2025
Primary completion
Feb 28, 2026
Completion
Feb 28, 2026

Study Design

Enrollment
90 participants (estimated)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT

Arms

  • Experimental: IMST
    Using the POWERBreathe pressure threshold training device, participants will perform 30 inspiratory maneuvers (5 sets of 6, 1 min rest) 6 days/week for 3 months. This is an over the counter product that will be used according to its instructions. The IMST group will train at 75% maximal inspiratory pressure.
  • Sham Comparator: Sham/Placebo
    Using the POWERBreathe pressure threshold training device, participants will perform 30 inspiratory maneuvers (5 sets of 6, 1 min rest) 6 days/week for 3 months. This is an over the counter product that will be used according to its instructions. The Sham group will train at 15% maximal inspiratory pressure.

Primary Outcome Measure

Systolic Blood Pressure [ Time Frame: 3 months ]

Central Contacts

Locations (2)

FacilityCityStateZIPSite coordinators
Seattle Children's HospitalSeattleWashington98102
Kalie Tommerdahl
[email protected]
206-616-9015
Kalie Tommerdahl, MD (PRINCIPAL_INVESTIGATOR)
University of Washington Medicine Diabetes InstituteSeattleWashington98109
Kalie Tommerdahl, MD
[email protected]
206) 616-9015
Kalie Tommerdahl, MD (PRINCIPAL_INVESTIGATOR)

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By research site
Seattle Children's Hospital· Seattle, WAUniversity of Washington Medicine Diabetes Institute· Seattle, WA

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