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

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.

Study Overview

• Status: Recruiting
• Conditions: Diabetes Mellitus Type 2
• Intervention / Treatment: Device: Inspiratory Muscle Strength Training (IMST); Device: Sham Training

• Study Type: Interventional
• Enrollment (Estimated): 90
• Phase: Not Applicable

Contacts and Locations

• Study Contact: Name: Kalie Tommerdahl, MD; Phone Number: (206) 616-9015; Email: ktomme@uw.edu

Study Locations

• United States
  • Washington
    • Seattle, Washington, United States, 98102
      • Recruiting
      • Seattle Children's Hospital
      • Principal Investigator: Kalie Tommerdahl, MD
      • Contact: Kalie Tommerdahl; Phone Number: 206-616-9015; Email: ktomme@uw.edu
    • Seattle, Washington, United States, 98109
      • Not yet recruiting
      • University of Washington Medicine Diabetes Institute
      • Principal Investigator: Kalie Tommerdahl, MD
      • Contact: Kalie Tommerdahl, MD; Phone Number: 206) 616-9015; Email: ktomme@uw.edu

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Child; Adult
• Accepts Healthy Volunteers: No

Description

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

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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.

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Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
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.	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.
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.	Device: Sham Training; The same training regiment but at much lower resistance, offering little to strength training impact.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Systolic Blood Pressure	Measures of casual clinic and 24-hour ambulatory blood pressure monitoring	3 months

Secondary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Seattle Children's Hospital
• Collaborators: University of Washington

Study record dates

Study Major Dates

• Study Start (Actual): April 30, 2025
• Primary Completion (Estimated): February 28, 2026
• Study Completion (Estimated): February 28, 2026

Study Registration Dates

• First Submitted: April 14, 2025
• First Submitted That Met QC Criteria: April 14, 2025
• First Posted (Actual): April 20, 2025

Study Record Updates

• Last Update Posted (Actual): June 13, 2025
• Last Update Submitted That Met QC Criteria: June 10, 2025
• Last Verified: June 1, 2025

More Information

Terms related to this study

• Keywords: Type 2 Diabetes; Blood Pressure; Diabetic Kidney Disease; Cardiovascular Function; Kidney Health; Inspiratory Strength Training
• Additional Relevant MeSH Terms: Endocrine System Diseases; Pathologic Processes; Metabolic Diseases; Respiratory Tract Diseases; Respiration Disorders; Glucose Metabolism Disorders; Diabetes Mellitus, Type 2; Diabetes Mellitus; Respiratory Aspiration
• Other Study ID Numbers: STUDY00005096

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: Yes
• product manufactured in and exported from the U.S.: No