NCT07859943Not yet recruiting
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
Source: ClinicalTrials.gov · Last updated 8 Oct 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Not yet recruiting
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- First submitted
- 30 Sept 2026
- Start date
- 1 Jan 2027
- Primary completion date
- 1 Sept 2028
- Lead sponsor
- Florida State University
- Diseases
- High blood pressure, Type 1 diabetes
- NCT number
- NCT07859943
What you commit to
- Study type: Interventional
- Planned participants: 30
- From 1 Jan 2027 to the primary completion date, 1 Sept 2028
- 2 sites in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Active nicotine or illegal drug use
Other illness
- 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
- Significant organ system dysfunction, such as severe pulmonary, renal, hepatic, or cardiovascular disease
- Diagnosed neuropathic or psychiatric illness
- 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
Lab values
- Diagnosed anemia or known hemoglobin less than 10 g/dL
Other
- 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
- Alcohol consumption totaling more than 10 standard drinks per week
- Unable to grant voluntary informed consent
- Unable or unwilling to follow the study protocol
Who the study is looking for
- 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
Age in the registry: 18 years to 35 years · Sex: All · Does not accept healthy volunteers
Sites (2)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Cardiovascular and Applied Physiology Laboratory Coordinator of this site? Confirm its status | Tallahassee | United States | Unknown status |
| Florida State University Coordinator of this site? Confirm its status | Tallahassee | United States | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.