Effects of High-Resistance Inspiratory Muscle Strength Training on Cardiorenal and Vascular Function in Youth and Young Adults With Type 2 Diabetes (IMST)

Seattle Children's Healthcare System

Status: Not yet enrolling

Conditions: Diabetes Mellitus Type 2

Treatments: Device: Inspiratory Muscle Strength Training (IMST); Device: Sham Training

Study type: Interventional

Funder types: Other

Identifiers

NCT06936670

STUDY00005096

Details and patient eligibility

About

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). We 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.

Enrollment: 90 estimated patients

Sex: All

Ages: 14 to 40 years old

Volunteers: No Healthy Volunteers

Inclusion and 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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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90 participants in 2 patient groups

IMST Group

Experimental group

Description:

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.

Treatment:

Device: Inspiratory Muscle Strength Training (IMST)

Sham Group

Sham Comparator group

Description:

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.

Treatment:

Device: Sham Training