NCT06936670

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

• Status: Recruiting
• Phase: N/A
• Study type: Interventional
• Enrollment: 90 (estimated)
• Sponsor: Seattle Children's Hospital · Academic / Other
• Sex: All
• Age: 14 Years – 40 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Diabetes Mellitus Type 2

Interventions

Type	Name	Description
DEVICE	Inspiratory Muscle Strength Training (IMST)	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.
DEVICE	Sham Training	The same training regiment but at much lower resistance, offering little to strength training impact.

Timeline

• Start date: 2025-04-30
• Primary completion: 2026-02-28
• Completion: 2026-02-28
• First posted: 2025-04-20
• Last updated: 2025-06-13

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated device study