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| Name | Class |
|---|---|
| University of Washington | OTHER |
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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| IMST | Experimental | 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. |
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| Sham/Placebo | Sham Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Inspiratory Muscle Strength Training (IMST) | Device | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| Systolic Blood Pressure | Measures of casual clinic and 24-hour ambulatory blood pressure monitoring | 3 months |
| Measure | Description | Time Frame |
|---|---|---|
| Endothelial function | Measured by brachial artery flow-mediated dilation and endothelial cell collection and analysis. | 3 months |
| Arterial stiffness | Measured by carotid-femoral pulse-wave velocity and carotid-radial pulse-wave analysis using a SphygmoCor. |
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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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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Kalie Tommerdahl, MD | Contact | (206) 616-9015 | ktomme@uw.edu |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Seattle Children's Hospital | Recruiting | Seattle | Washington | 98102 | United States |
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| Sham Training | Device | The same training regiment but at much lower resistance, offering little to strength training impact. |
|
| 3 months |
| Kidney Function | Measured by estimated glomerular filtration rate and albuminuria assessments | 3 months |
| Body Composition | Measured by BIS (Bioimpedance spectroscopy) | 3 months |
| University of Washington Medicine Diabetes Institute | Not yet recruiting | Seattle | Washington | 98109 | United States |
|
| ID | Term |
|---|---|
| D003924 | Diabetes Mellitus, Type 2 |
| D003928 | Diabetic Nephropathies |
| ID | Term |
|---|---|
| D003920 | Diabetes Mellitus |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D004700 | Endocrine System Diseases |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D048909 | Diabetes Complications |
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