RecruitingNot ApplicableNCT06936670

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

Sponsor

Seattle Children's Hospital

Enrollment

90 participants

Start Date

Apr 30, 2025

Study Type

INTERVENTIONAL

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.

Eligibility

Min Age: 14 YearsMax Age: 40 Years

Plain Language Summary

Simplified for easier understanding

This study is testing whether high-resistance inspiratory muscle strength training (IMST) — a breathing exercise program using a special resistance device — improves cardiovascular health, lung strength, and overall physical fitness. IMST involves breathing in forcefully against resistance for short daily sessions. **You may be eligible if...** - You are an adult interested in improving cardiovascular or respiratory fitness - You have some degree of reduced breathing muscle strength or cardiovascular risk - You are able to perform breathing exercises safely **You may NOT be eligible if...** - You have severe lung disease such as advanced COPD or recent pneumothorax (collapsed lung) - You have uncontrolled heart problems - You have had recent thoracic or abdominal surgery - You are pregnant - You have conditions where forceful breathing could be harmful Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

DEVICEInspiratory 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.

DEVICESham Training

The same training regiment but at much lower resistance, offering little to strength training impact.

Locations(2)

Seattle Children's Hospital

Seattle, Washington, United States

University of Washington Medicine Diabetes Institute

Seattle, Washington, United States

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NCT06936670