High-resistance inspiratory muscle training to improve heart, blood vessel, and kidney health in young people with type 2 diabetes
Effects of High-Resistance Inspiratory Muscle Strength Training on Cardiorenal and Vascular Function in Youth and Young Adults With Type 2 Diabetes
This trial will test whether about 5 minutes a day of high-resistance inspiratory muscle strength training can lower blood pressure and improve vascular and kidney function in youth and young adults with type 2 diabetes.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 90 (estimated) |
| Ages | 14 Years to 40 Years |
| Sex | All |
| Sponsor | Seattle Children's Hospital Academic / other |
| Locations | 2 sites (Seattle, Washington and 1 other locations) |
| Trial ID | NCT06936670 on ClinicalTrials.gov |
What this trial studies
Participants aged 14–40 with at least one year of type 2 diabetes and HbA1c <12% are randomized to 3 months of daily high-resistance, short-duration inspiratory muscle strength training (30 resisted inhalations, ~5 min/day) or sham training. The study measures casual and 24-hour systolic blood pressure, endothelial function, and arterial stiffness, and evaluates kidney function through eGFR and albuminuria before and after the intervention. Translational mechanistic assays will examine nitric oxide bioavailability, endothelial nitric oxide synthase activation, and markers of oxidative stress and circulating factors to explore how IMST may work. The intervention is delivered at sites in Seattle with in-person assessments at baseline and follow-up.
Who should consider this trial
Good fit: Ideal candidates are people aged 14–40 with type 2 diabetes for at least one year, HbA1c under 12%, and without advanced kidney disease or uncontrolled severe hypertension.
Not a fit: People with very long-standing diabetes, significant kidney impairment (eGFR <60 ml/min/1.73 m2 or very high albuminuria), or uncontrolled blood pressure are unlikely to be eligible and may not benefit.
Why it matters
Potential benefit: If successful, this brief daily breathing exercise could reduce blood pressure and improve vascular and kidney health with minimal time burden.
How similar studies have performed: Small adult trials of high-resistance IMST have shown reductions in systolic blood pressure and improvements in vascular function, but its effects in youth with type 2 diabetes are largely untested.
Eligibility criteria
Show full inclusion / exclusion criteria
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. \-
Where this trial is running
Seattle, Washington and 1 other locations
- Seattle Children's Hospital — Seattle, Washington, United States (Recruiting)
- University of Washington Medicine Diabetes Institute — Seattle, Washington, United States (Not_yet_recruiting)
Study contacts
- Study coordinator: Kalie Tommerdahl, MD
- Email: ktomme@uw.edu
- Phone: (206) 616-9015
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.