MedTrace Logo

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

NCT06936670 · Status: RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 90

Last updated 2025-06-13

No results posted yet for this study

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

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.

Sponsors & Collaborators

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
14 Years
Max Age
40 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-04-30
Primary Completion
2026-02-28
Completion
2026-02-28
FDA Device
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06936670 on ClinicalTrials.gov