Inspiratory Muscle Strength Training for Type 2 Diabetes

(IMST Trial)

Recruiting at 1 trial location

Overseen By Kalie Tommerdahl, MD

Age: < 65

Sex: Any

Trial Phase: Academic

Sponsor: Seattle Children's Hospital

Disqualifiers: T2D >18 years, eGFR <60, ACR >2200, BP >160/100

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Compensation: Varies

Number of Visits: Unknown

Duration: 12 weeks

90 Participants Needed

Trial Summary

Will I have to stop taking my current medications?

The trial information does not specify whether you need to stop taking your current medications. It's best to discuss this with the trial coordinators or your doctor.

What data supports the effectiveness of the treatment Inspiratory Muscle Strength Training (IMST) for Type 2 Diabetes?

Research shows that Inspiratory Muscle Training (IMT) can improve respiratory muscle strength and exercise capacity in people with Type 2 diabetes, which may help with overall physical function. Additionally, IMT has been found to have benefits for various disorders, suggesting it could be a helpful treatment for managing some complications of diabetes. ^{1 2 3 4 5}

Is inspiratory muscle strength training safe for humans?

Inspiratory muscle strength training (IMST) has been studied in people with type 2 diabetes and appears to be safe, as no significant safety concerns were reported in the studies reviewed. ^{1 2 3 6 7}

How does inspiratory muscle strength training differ from other treatments for type 2 diabetes?

Inspiratory muscle strength training (IMST) is unique because it focuses on strengthening the muscles used for breathing, which can improve respiratory function and exercise capacity in people with type 2 diabetes. Unlike traditional treatments that primarily target blood sugar levels, IMST addresses the often-overlooked respiratory muscle weakness associated with diabetes. ^{1 2 3 4 8}

What is the purpose of this trial?

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.

Eligibility Criteria

This trial is for young individuals with Type 2 Diabetes who are interested in trying a new, short daily breathing exercise. Participants should be willing to perform either the actual or sham (fake) training and be available for follow-up assessments.

Inclusion Criteria

HbA1C less than 12%

I am between 14 and 40 years old.

I have been diagnosed with type 2 diabetes for over a year.

Exclusion Criteria

Albumin-to-creatinine ratio (ACR) greater than 2200mg/g

Blood pressure greater than 160/100 mm Hg

My kidney function is reduced.

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants undergo high-resistance inspiratory muscle strength training (IMST) or sham training for 3 months

12 weeks

Weekly check-ins (virtual or in-person)

Follow-up

Participants are monitored for changes in blood pressure, endothelial function, and kidney function after treatment

4 weeks

Treatment Details

Interventions

• Inspiratory Muscle Strength Training (IMST)
• Sham Training

Trial Overview The study tests if doing high-resistance inspiratory muscle strength training (IMST), which involves breathing against resistance for about 5 minutes a day, can improve blood pressure, blood vessel function, and kidney health compared to fake training.

Participant Groups

Group I: IMST Experimental Treatment 1 Intervention

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.

Group II: Sham/Placebo Placebo Group 1 Intervention

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.

Who Is Running the Clinical Trial?

Seattle Children's Hospital

Lead Sponsor

Trials

319

Recruited

5,232,000+

University of Washington

Collaborator

Trials

1,858

Recruited

2,023,000+

Findings from Research

Inspiratory muscle training (IMT) significantly improved inspiratory muscle strength and walking distance in a group of 67 adults with obesity over a 4-week period, indicating its efficacy as a practical intervention.

The study suggests that IMT can enhance functional fitness in obese adults, potentially leading to increased participation in physical activities, making it a valuable self-administered strategy for home use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Efficacy of inspiratory muscle training as a practical and minimally intrusive technique to aid functional fitness among adults with obesity. Edwards, AM., Graham, D., Bloxham, S., et al.[2018]

Inspiratory muscle strength training (IMST) significantly increases maximal inspiratory pressure and reduces dyspnea in both older adults without COPD and those with COPD, demonstrating its efficacy as a respiratory intervention.

IMST particularly enhances functional status and quality of life in older adults without COPD, suggesting that this training can benefit a broader population beyond just COPD patients.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Comparison of inspiratory muscle strength training effects between older subjects with and without chronic obstructive pulmonary disease. Huang, CH., Yang, GG., Wu, YT., et al.[2016]

References

1. Australia pubmed.ncbi.nlm.nih.gov

Effect of inspiratory muscle training on respiratory muscle strength and functional capacity in patients with type 2 diabetes mellitus: A randomized clinical trial. [2021]

2. United States pubmed.ncbi.nlm.nih.gov

Inspiratory muscle training in type 2 diabetes with inspiratory muscle weakness. [2022]

3. United States pubmed.ncbi.nlm.nih.gov

Inspiratory Muscle Training on Glucose Control in Diabetes: A Randomized Clinical Trial. [2022]

4. Brazil pubmed.ncbi.nlm.nih.gov

Effects of Inspiratory Muscle Training in Type 2 Diabetes: A Systematic Review. [2023]

5. Germany pubmed.ncbi.nlm.nih.gov

Inspiratory muscle training in patients with diabetic autonomic neuropathy: a randomized clinical trial. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Associations of Low-Intensity Resistance Training with Body Composition and Lipid Profile in Obese Patients with Type 2 Diabetes. [2022]

7. Netherlands pubmed.ncbi.nlm.nih.gov

Efficacy of inspiratory muscle training as a practical and minimally intrusive technique to aid functional fitness among adults with obesity. [2018]

8. Singapore pubmed.ncbi.nlm.nih.gov

Comparison of inspiratory muscle strength training effects between older subjects with and without chronic obstructive pulmonary disease. [2016]