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Inspiratory Muscle Strength Training in Adults With Type 1 Diabetes

Time-Efficient Inspiratory Muscle Strength Training as a New Approach to Improve Cardiovascular Function Among Adults With Type 1 Diabetes

Who can join

As published by the study on ClinicalTrials.gov. "Not stated" means the study hasn't said — ask the study team.

Age
18 Years to 35 Years
Sex
All sexes
Healthy volunteers
Not accepted
Compensation
Not stated

Other requirements are listed under Eligibility below. Only the study team can confirm whether you can join.

What to expect

No one can promise a trial will help you personally — that is what the research is trying to find out.

What participation involves

  • Time periods mentioned: 8 weeks
  • Procedures mentioned: Ultrasound

Only what the study's summary and detailed description on ClinicalTrials.gov say. Time periods may describe the whole study or a part of it — ask the study team what applies to you.

Show the study's own words
  • "Participants will be randomized 2:1 to high-resistance or very-low-resistance sham training using a POWERbreathe K3 device and will complete 30 training breaths per day at home for eight weeks."
  • "All participants complete approximately 56 daily training sessions over eight weeks, each consisting of five bouts of six forceful inhalations with about 30 seconds of rest between bouts."
  • "Testing visits at week 0 and week 8 include laboratory blood pressure, brachial artery flow-mediated dilation and post-occlusion reactive hyperemia by high-resolution ultrasound, central blood pressure and arterial stiffness by applanation tonometry, and isometric handgrip exercise testing with post-exercise circulatory occlusion."
Compensation
Not stated
  • Study-related exams and procedures are typically provided at no cost. This is how many trials work in general — confirm the details for this study with the study team.
  • Participants are monitored closely by the research team throughout the study.
  • Some participants may receive access to an investigational treatment, which is still being studied.
  • Your participation helps researchers learn whether this approach could help future patients.

About this study

In plain language

This study tests whether daily breathing muscle training lowers blood pressure and helps blood vessels work better in adults ages 18 to 35 with type 1 diabetes. Participants use a breathing device at home for 30 breaths a day for 8 weeks, with either high or very low resistance.

Adults with type 1 diabetes have elevated cardiovascular disease risk, and systolic blood pressure is a leading modifiable contributor to that risk. Aerobic exercise lowers blood pressure but poses time and glycemic-management barriers for people with type 1 diabetes. Inspiratory muscle strength training is a brief, home-based, device-based intervention that takes about five minutes per day and has lowered systolic blood pressure in other adult populations. This pilot trial will test whether eight weeks of daily high-resistance inspiratory muscle strength training lowers blood pressure and improves vascular function in adults with type 1 diabetes. Participants will be randomized 2:1 to high-resistance or very-low-resistance sham training using a POWERbreathe K3 device and will complete 30 training breaths per day at home for eight weeks. Outcomes are assessed before and after the training period.

Compensation is read from the study's own description and may be missing — always confirm with the study team.

Eligibility

Who can join

  • Age 18 to 35, with type 1 diabetes diagnosed more than 1 year before screening.
  • A1c (a measure of average blood sugar) of 10.0% or less in the last 3 months, or tested at screening.
  • Body mass index (BMI, a measure of weight compared with height) of 18 to 29.9.
  • Same insulin delivery method for the past 30 days.
  • Able to read all device instructions and insulin pump settings.
  • Kidney filtering test (eGFR) result of at least 60 in the last 3 months, or tested at screening.
  • Use an insulin pump or take several insulin shots each day.
  • At least 3 diabetes care visits in the past 12 months.

Who can't join

  • Hospital stay for diabetes in the past 12 months, including dangerous acid buildup in the blood or very low blood sugar; or taking diabetes medicines other than insulin.
  • Blood pressure with a top number of 140 or higher or a bottom number of 90 or higher.
  • More than 150 minutes of planned exercise per week for the past 3 months, or weight changed by more than 5% in that time.
  • Pregnant, breastfeeding, or planning to become pregnant during the study.
  • Serious organ disease, such as severe lung, kidney, liver, or heart disease; diagnosed anemia (low red blood cells) or hemoglobin below 10 g/dL; or a diagnosed nerve or mental health illness.
  • Current nicotine or illegal drug use, or more than 10 standard alcoholic drinks per week.
  • Unable to freely agree to join after learning about the study, or unable or unwilling to follow study rules.
  • Past lung collapse that happened on its own; a collapsed lung not fully healed; a pacemaker or medical implant with magnets or electronics; or any eardrum condition, such as a tear that has not fully healed.

Simplified for readability. The official criteria below are what the study team uses.

Official eligibility criteria

Inclusion Criteria: * Age 18 to 35 years * Type 1 diabetes diagnosed more than 1 year before screening * Hemoglobin A1c (HbA1c) 10.0% or less within the last 3 months (may be measured at screening)- Body mass index 18 to 29.9 kg/m\^2 * Stable insulin delivery method for the past 30 days * Ability to read all device instructions and insulin pump settings * Estimated glomerular filtration rate at least 60 mL/min/1.73 m\^2 within the last 3 months (may be measured at screening) * Use of an insulin pump or insulin delivery by multiple daily injections * Attendance at 3 or more diabetes care visits over the past 12 months Exclusion Criteria: * Diabetes-related hospitalization, including for diabetic ketoacidosis or severe hypoglycemia, within 12 months of screening * Poorly controlled hypertension, defined as systolic blood pressure at least 140 mmHg or diastolic blood pressure at least 90 mmHg * Taking diabetes medications other than insulin * Structured exercise more than 150 minutes per week for the last 3 months * Pregnant, lactating, or planning to become pregnant within the study period * Unstable weight, defined as more than 5% change in the last 3 months * Significant organ system dysfunction, such as severe pulmonary, renal, hepatic, or cardiovascular disease * Diagnosed anemia or known hemoglobin less than 10 g/dL * Diagnosed neuropathic or psychiatric illness * Active nicotine or illegal drug use * Alcohol consumption totaling more than 10 standard drinks per week * Unable to grant voluntary informed consent * Unable or unwilling to follow the study protocol * Per the POWERbreathe device user manual: history of spontaneous pneumothorax; a collapsed lung that has not fully healed; a pacemaker or medical implant containing magnets or electronics; any condition of the eardrum, such as a burst eardrum that has not fully healed

Study sites (2)

FL