Diabetes Mellitus Type 2
Conditions
Keywords
Type 2 Diabetes, Inspiratory Strength Training, Blood Pressure, Kidney Health, Cardiovascular Function, Diabetic Kidney Disease
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.
Interventions
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.
DEVICESham Training
The same training regiment but at much lower resistance, offering little to strength training impact.
Sponsors
University of Washington
Seattle Children's Hospital
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Eligibility
Sex/Gender
ALL
Age
14 Years to 40 Years
Healthy volunteers
No
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. \-
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Systolic Blood Pressure | 3 months | Measures of casual clinic and 24-hour ambulatory blood pressure monitoring |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Endothelial function | 3 months | Measured by brachial artery flow-mediated dilation and endothelial cell collection and analysis. |
| Arterial stiffness | 3 months | Measured by carotid-femoral pulse-wave velocity and carotid-radial pulse-wave analysis using a SphygmoCor. |
| Kidney Function | 3 months | Measured by estimated glomerular filtration rate and albuminuria assessments |
| Body Composition | 3 months | Measured by BIS (Bioimpedance spectroscopy) |
Countries
United States
Contacts
Primary ContactKalie Tommerdahl, MD
Outcome results
None listed