Recruiting

IMST

Sponsor:

Seattle Children's Hospital

Code:

NCT06936670

Conditions

Diabetes Mellitus Type 2

Eligibility Criteria

Sex: All

Age: 14 - 40

Healthy Volunteers: Not accepted

Interventions

Inspiratory Muscle Strength Training (IMST)

Sham Training

Study Details

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

Study ID

NCT06936670

Start date

Apr 30, 2025

Status verified date

Jun, 2025

Completion date

Feb 28, 2026

Anticipated

Primary completion date

Feb 28, 2026

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 14 - 40

Healthy Volunteers: Not accepted

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 Design

Enrollment

90 participants

Anticipated

Allocation

Randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

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.

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.

Interventions

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 Training

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

Primary outcome measure

  • Systolic Blood Pressure [ Time Frame: 3 months ]

Central Contacts and Locations

Central contacts

Kalie Tommerdahl, MD

(206) 616-9015ktomme@uw.edu

Locations

Seattle Children's Hospital

Recruiting

Seattle, Washington, United States, 98102

Contacts

Kalie Tommerdahl

206-616-9015ktomme@uw.edu

Principal Investigator:

Kalie Tommerdahl, MD

More Information

Sponsor

Seattle Children's Hospital

Last update posted

Jun 13, 2025

Last verified

Jun, 2025

Keywords

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

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-10. This information was provided to ClinicalTrials.gov by Seattle Children's Hospital on 2025-06-13.