NCT Number: NCT06936670
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.
Interested in participating?
Request Info14 year–40 year
All sexes
Interventional
Not applicable
Seattle Children's Hospital, Seattle, Washington, United States
Healthy volunteers accepted: No
Only the study team can determine whether someone qualifies for participation.
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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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.
The same training regiment but at much lower resistance, offering little to strength training impact.
Time frame: 3 months
Measures of casual clinic and 24-hour ambulatory blood pressure monitoring
Time frame: 3 months
Measured by brachial artery flow-mediated dilation and endothelial cell collection and analysis.
Time frame: 3 months
Measured by carotid-femoral pulse-wave velocity and carotid-radial pulse-wave analysis using a SphygmoCor.
Time frame: 3 months
Measured by estimated glomerular filtration rate and albuminuria assessments
Time frame: 3 months
Measured by BIS (Bioimpedance spectroscopy)
Contact information is provided by the study sponsor or research team.
Seattle Children's Hospital
Other
Acronym: IMST
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