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

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests a new method to help young people with type 2 diabetes manage their condition using Inspiratory Muscle Strength Training (IMST). IMST involves breathing exercises that take about 5 minutes a day and may improve heart and blood vessel health. The trial will compare IMST to a sham (fake) version to determine its effectiveness in lowering blood pressure and improving kidney health. Suitable participants are those aged 14 to 40 who have had type 2 diabetes for at least one year and face daily challenges related to it. As an unphased trial, this study provides a unique opportunity to explore innovative treatment options for managing type 2 diabetes.

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 prior data suggests that this inspiratory muscle strength training is safe for youth with Type 2 Diabetes?

Studies have shown that inspiratory muscle strength training (IMST) is generally easy for people to handle. Research indicates that IMST can significantly lower systolic blood pressure without causing major side effects. One study found that blood pressure dropped from 135 to 126 mm Hg after using IMST, and this improvement lasted for weeks.

While no harmful effects have been reported at the 75% resistance level used in some studies, long-term safety information remains limited. However, the availability of similar devices over-the-counter suggests they are generally safe. Participants should still consult their healthcare provider to ensure it's a suitable option for them. ^{1 2 3 4 5}

Why are researchers excited about this trial?

Inspiratory Muscle Strength Training (IMST) is unique because it offers a non-drug approach to managing Type 2 Diabetes. While most treatments rely on medications like metformin or insulin to control blood sugar levels, IMST focuses on strengthening the respiratory muscles, potentially improving metabolic health and cardiovascular fitness. Researchers are excited about this technique because it could offer a simple, at-home intervention that complements existing treatments, providing additional health benefits without the side effects associated with some medications. Additionally, IMST is performed using a device that is accessible and easy to use, making it a practical option for many patients.

What evidence suggests that inspiratory muscle strength training is effective for type 2 diabetes?

Research has shown that Inspiratory Muscle Strength Training (IMST), which participants in this trial may receive, can help manage certain health issues for people with Type 2 Diabetes (T2D). Studies have found that IMST can lower systolic blood pressure by about 9 points. It also reduces insulin resistance, which is crucial for managing diabetes. Additionally, IMST can enhance physical ability, making it easier for people to stay active. Although some studies indicate it doesn't significantly change blood sugar levels, the benefits for heart health and breathing make IMST a promising option for managing T2D. ^{1 3 4 6 7}

Are You a Good Fit for This Trial?

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 for a Trial Participant

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

What Are the Treatments Tested in This Trial?

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.

How Is the Trial Designed?

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+

Published Research Related to This Trial

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]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC10358310/

Effects of Inspiratory Muscle Training in Type 2 Diabetes It was found that after inspiratory muscle training protocols, there was a reduction in the sympathetic modulation and an increase in functional capacity.

2. clinicaltrials.gov clinicaltrials.gov/study/NCT05643768

Inspiratory Muscle Strength Training in Adults With Type 2 ... This clinical research study will investigate the effects of 6 weeks of inspiratory muscle strength training on metabolic and cardiovascular outcomes in adults ...

3. frontiersin.org frontiersin.org/journals/sports-and-active-living/articles/10.3389/fspor.2024.1423308/full

Acute and chronic effects of inspiratory muscle training in ... This type of ventilatory training has shown to decrease blood glucose levels, decrease insulin resistance and diaphragmatic breathing capacity, ...

4. medrxiv.org medrxiv.org/content/10.1101/2023.10.27.23297688v1.full

Protocol for the Diabetes Inspiratory Training (DIT) Clinical ... With just six weeks of training (5 days/week), high resistance-IMST has been shown to lower systolic blood pressure (systolic BP) by ∼9 mmHg in ...

5. sciencedirect.com sciencedirect.com/science/article/pii/S156607021930089X

Acute inspiratory muscle exercise effect on glucose levels ... In type 2 diabetes, inspiratory muscle exercise does not improve blood glucose levels, glucose variability and autonomic modulation.

6. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11427269/

protocol for the diabetes inspiratory training clinical trial We expect the IMST intervention to enhance vascular health, as well as improvements in metabolic health. We propose that IMST may enhance ...

7. ahajournals.org ahajournals.org/doi/10.1161/JAHA.121.020980

Time‐Efficient Inspiratory Muscle Strength Training Lowers ... Casual systolic blood pressure decreased from 135±2 mm Hg to 126±3 mm Hg (P<0.01) with IMST, which was ≈75% sustained 6 weeks after IMST (P<0.01) ...