Actively Recruiting
Effects of High-Resistance Inspiratory Muscle Strength Training on Cardiorenal and Vascular Function in Youth and Young Adults With Type 2 Diabetes
Led by Seattle Children's Hospital · Updated on 2025-06-13
90
Participants Needed
2
Research Sites
N/A
Total Duration
On this page
Sponsors
S
Seattle Children's Hospital
Lead Sponsor
U
University of Washington
Collaborating Sponsor
AI-Summary
What this Trial Is About
Researchers are evaluating the effects of high-resistance, short-duration inspiratory muscle strength training (IMST) on heart, kidney, and blood vessel function in youth and young adults aged 14 to 40 with type 2 diabetes (T2D). This study aims to compare IMST to a sham training to see how it affects blood pressure, blood vessel health, kidney function, and related biological mechanisms such as nitric oxide availability and oxidative stress. Participants will use the POWERBreathe pressure threshold training device to perform 30 inhalations daily, divided into 5 sets of 6 breaths with 1-minute rests, six days per week for three months. The IMST group will train at 75% of their maximal inspiratory pressure, while the sham group will train at 15%, providing a lower resistance that serves as a control. This device is an over-the-counter product used according to its instructions. During the study, researchers will monitor changes in casual and 24-hour systolic blood pressure, endothelial function, arterial stiffness, kidney function (including estimated glomerular filtration rate and albuminuria), and body composition after three months. The study includes blood and other biological tests to explore the underlying mechanisms of IMST. Participants will be monitored for safety and outcomes throughout the three-month training period.
CONDITIONS
Brief Title
Effects of High-Resistance Inspiratory Muscle Strength Training on Cardiorenal and Vascular Function in Youth and Young Adults With Type 2 Diabetes
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Aged between 14 and 40 years
- Diagnosed with type 2 diabetes for at least one year
- HbA1C less than 12%
You will not qualify if you...
- Having type 2 diabetes for more than 18 years
- Estimated glomerular filtration rate (eGFR) less than 60 ml/min/1.73m2
- Albumin-to-creatinine ratio (ACR) greater than 2200 mg/g
- Blood pressure greater than 160/100 mm Hg
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Duration - 3 months
Participants perform inspiratory muscle strength training using a handheld device. They complete 30 inspiratory maneuvers (5 sets of 6 with 1-minute rest) 6 days per week for 3 months, either at high resistance or low resistance depending on group assignment.
Daily training at home, with periodic in-person visits for monitoring
Trial Site Locations
Total: 2 locations
1
Seattle Children's Hospital
Seattle, Washington, United States, 98102
Actively Recruiting
2
University of Washington Medicine Diabetes Institute
Seattle, Washington, United States, 98109
Not Yet Recruiting
Research Team
K
Kalie Tommerdahl, MD
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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