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

Not Applicable

Recruiting

• Conditions: Diabetes Mellitus Type 2

• Registration Number: NCT06936670
• Lead Sponsor: Seattle Children's Hospital

Brief 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.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2025-04-14
• Study First Submitted QC: 2025-04-14
• Study First Posted: 2025-04-20
• Study Start: 2025-04-30
• Status Verified: 2025-06
• Last Update Submitted: 2025-06-10
• Last Update Posted: 2025-06-13
• Primary Completion: 2026-02-28
• Study Completion: 2026-02-28

Recruitment & Eligibility

• Status: RECRUITING
• Sex: All
• Target Recruitment: 90

Inclusion Criteria

Aged 14-40, have had T2D for a least one year, HbA1C less than 12%.

Exclusion Criteria

Have had type II diabetes for more than 18 years, estimated glomerular filtration rate (eGFR) less than 60 ml/min/1.73m2 or Albumin-to-creatinine ratio (ACR) greater than 2200mg/g, blood pressure greater than 160/100 mm Hg.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Systolic Blood Pressure	3 months	Measures of casual clinic and 24-hour ambulatory blood pressure monitoring

Secondary Outcome Measures

Name	Time	Method
Endothelial function	3 months	Measured by brachial artery flow-mediated dilation and endothelial cell collection and analysis.
Arterial stiffness	3 months	Measured by carotid-femoral pulse-wave velocity and carotid-radial pulse-wave analysis using a SphygmoCor.
Kidney Function	3 months	Measured by estimated glomerular filtration rate and albuminuria assessments
Body Composition	3 months	Measured by BIS (Bioimpedance spectroscopy)

Trial Locations

Locations (2)

Seattle Children's Hospital; 🇺🇸 Seattle, Washington, United States

University of Washington Medicine Diabetes Institute; 🇺🇸 Seattle, Washington, United States