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

NCT06936670 | Recruiting FDA Device

• 1 other identifier: STUDY00005096
• Study Type: interventional
• Target: 90
• Locations: 1 country
• Sites: 2

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.

Conditions

Diabetes Mellitus Type 2

Keywords

Type 2 Diabetes; Inspiratory Strength Training; Blood Pressure; Kidney Health; Cardiovascular Function; Diabetic Kidney Disease

Outcome Measures

Primary Outcomes (1)

• Systolic Blood Pressure

  Measures of casual clinic and 24-hour ambulatory blood pressure monitoring

  3 months

Secondary Outcomes (4)

• Endothelial function

  3 months

• Arterial stiffness

  3 months

• Kidney Function

  3 months

• Body Composition

  3 months

Study Arms (2)

IMST

EXPERIMENTAL

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)

Sham/Placebo

SHAM COMPARATOR

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

Interventions

Inspiratory Muscle Strength Training (IMST) DEVICE

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.

IMST

Sham Training DEVICE

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

Sham/Placebo

Eligibility Criteria

• Age: 14 Years - 40 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

Sponsors & Collaborators

• Seattle Children's Hospital: lead
• University of Washington: collaborator

Study Sites (2)

Seattle Children's Hospital

Seattle, Washington, 98102, United States

RECRUITING

University of Washington Medicine Diabetes Institute

Seattle, Washington, 98109, United States

NOT YET RECRUITING

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Diabetic Nephropathies

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Diabetes Complications

Central Study Contacts

Kalie Tommerdahl, MD

CONTACT

(206) 616-9015; ktomme@uw.edu

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Associate Professor of Pediatrics in the Division of Endocrinology and Diabetes at Seattle Children's Hospital and the University of Washington School of Medicine

Study Record Dates

• First Submitted: April 14, 2025
• First Posted: April 20, 2025
• Study Start: April 30, 2025
• Primary Completion: February 28, 2026
• Study Completion: February 28, 2026
• Last Updated: June 13, 2025

Record last verified: 2025-06

Locations

US (2)