Diabetes Mellitus, Type 2DITNCT05643768
Inspiratory Muscle Strength Training in Adults With Type 2 Diabetes
A study testing Inspiratory muscle strength training (IMST) in people with Diabetes Mellitus, Type 2 and Hypertension, run by University of Arizona at 1 site in United States.
Trial summary
This clinical research study will investigate the effects of 6 weeks of inspiratory muscle strength training on metabolic and cardiovascular outcomes in adults with recent-onset type 2 diabetes. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Diabetes Mellitus, Type 2, Hypertension
- What is being tested?
- Inspiratory muscle strength training (IMST)
- Type of treatment
- Lifestyle or therapy programme
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 11 participants
- Where
- 1 siteUnited States
- Study dates
- 30 Jun 2023to 6 May 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- diagnosed with type 2 diabetes by physician
- fasting plasma glucose levels ≥126 mg/dl and ≤240 mg/dl
- systolic blood pressure between 120-169 mmHg
- stable dose of medication (three months on the same dose)
- weight stable in the prior 3 months (<3.0 kg weight change) and willing to remain weight stable throughout the study
- absence of unstable clinical disease as determined by medical history
Who cannot join
- current smoker (including tobacco products, vaping devices, THC, etc…)
- have an uncontrolled medical condition (e.g., cancer)
- myocardial infarction or stroke within the previous 12 months
- performs regular aerobic exercise (>4 bouts/week)
- BMI ≥ 40 kg/m2
- systolic blood pressure <120 or ≥170 mmHg
Show all 14Show fewer
- diastolic blood pressure >100 or <60 mmHg
- Cheyne-Stokes respiration
- history of perforated eardrum
- history of glaucoma or retinopathy
- history of collapsed lung
- diagnosed with asthma
- pregnant, breastfeeding, or trying to become pregnant (self-reported)
- medications that, in the opinion of the study physician or nurse practitioner, may impact the outcomes of the study (e.g., steroids)
Trial locations and contacts
1 site in 1 country.
United States1 site
Arizona Respiratory and Neurophysiology Laboratory
Tucson, Arizona, 85724
About this study
Official title: Effects of Inspiratory Muscle Strength Training on Metabolic and Cardiovascular Health in Adults With Type 2 Diabetes
This clinical research study will investigate the effects of 6 weeks of inspiratory muscle strength training on metabolic and cardiovascular outcomes in adults with recent-onset type 2 diabetes.
Read the detailed description
Type 2 diabetes mellitus (T2DM) is at epidemic proportions in the United States and worldwide. It is a chronic obesity-associated metabolic disorder characterized by glucose dysregulation combined with insulin resistance and beta-cell defects. First-line T2DM treatments include lifestyle remedies, such as dietary modifications and exercise. Exercise, whether aerobic and/or resistance training, increases whole-body insulin sensitivity and stimulates muscle glucose uptake independent of insulin. The acute effects of exercise on muscle in patients with abnormal glucose regulation produce immediate improvements in blood glucose levels. In addition, when exercise is repeated over time, adaptations occur that include more long-lasting increases in insulin sensitivity. The effects of traditional exercise on glycemic control and insulin sensitivity in patients with T2DM are well established. However, adherence to traditional exercise programs is low, in part, due to lack of time and physical discomfort, and new regimens for T2DM treatment are needed.
Recently, a novel time-efficient respiratory exercise called Inspiratory Muscle Strength Training (IMST) was developed. IMST is distinct from other traditional forms of exercise as it is only 5 minutes per session and performed on a hand-held device during stationary sitting or standing. Typically, IMST comprises 5 sets of 6 inspiratory maneuvers with 1-minute rests between sets. Previous studies demonstrate that 6 weeks of IMST improve systolic blood pressure (SBP), sympathetic nervous system activity, and endothelial function in healthy individuals, middle-aged and older people, and adults with obstructive sleep apnea. These BP-lowering effects of IMST are significant for reducing the risks of cardiovascular disease (CVD), the number one cause of death in people living with diabetes. IMST is safe and tolerable, with adherence rates >90% in diverse populations, and presents a manageable program for improving metabolic health in T2DM patients who have difficulty maintaining a traditional exercise program requiring a large amount of time and physical exertion. It is unknown if IMST, a highly-abbreviated respiratory exercise that is not physically demanding, has beneficial effects on glycemic control and insulin sensitivity, in combination with its improvements on BP measures, in patients with T2DM. The potential for IMST to exert metabolic benefits in diabetic patients warrants assessment
- Conditions
- Diabetes Mellitus, Type 2, Hypertension
- Being tested
- Inspiratory muscle strength training (IMST)
- Keywords
- insulin sensitivity, blood pressure, blood glucose, non-pharmacological, inspiratory resistance training
- Medical subject headings
- Diabetes Mellitus, Type 2, Hypertension, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Inspiratory muscle strength training (IMST)Behavioural
Also called inspiratory resistance training, vascular conditioning exercise, inspiratory muscle training
30 breaths/day, 5 days/week, 6 weeks
| Study group | Role | What they receive |
|---|---|---|
| High-resistance IMST | Experimental | 30 breaths/day (5 sets of 6 breaths, one minute of rest between sets), 5 days/week, 6 weeks Receives: Behavioral: Inspiratory muscle strength training (IMST) |
| Low-resistance IMST | Active comparator | 30 breaths/day (5 sets of 6 breaths, one minute of rest between sets), 5 days/week, 6 weeks Receives: Behavioral: Inspiratory muscle strength training (IMST) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline fasting blood plasma glucose after 6 weeks of IMST
A blood sample will be collected after 12 hours of fasting. Blood and plasma will be separated and plasma glucose levels will be quantified.
Measured: Blood plasma collected and analyzed at baseline and after 6 weeks of training
Change from baseline fasting blood plasma Insulin after 6 weeks of IMST
A blood sample will be collected after 12 hours of fasting. Blood and plasma will be separated and plasma insulin levels will be quantified.
Measured: Blood plasma collected and analyzed at baseline and after 6 weeks of training
Change from baseline insulin sensitivity after 6 weeks of IMST
A blood sample will be collected after 12 hours of fasting. Insulin sensitivity will be calculated using the homeostatic model assessment of insulin resistance (HOMA-IR): (fasting serum insulin (mU/L) × fasting plasma glucose (mmol/L) × 22.5).
Measured: Blood plasma collected and analyzed at baseline and after 6 weeks of training
Secondary outcomes (2)
Change from baseline systolic blood pressure after 6 weeks of IMST
Change in systolic blood pressure (SBP) will be measured by both relative and absolute changes from baseline. SBP will be assessed in accordance with American College of Cardiology/American Heart Association guidelines. Measurements will be taken using an automated oscillometric sphygmomanometer and will be performed in triplicate over the brachial artery of the left arm after 5 minutes of quiet rest, with 1 minute of recovery between measures. SBP will be defined as the average of the 3 pressures.
Measured: Blood pressure will be assessed at baseline and after 6 weeks of training
Change from baseline Nitric Oxide-mediated Endothelial Dependent Dilation (EDD)
Brachial artery Flow Mediated Dilation (BA-FMD), a well-established measure of NO-mediated endothelial function, will be measured by both relative and absolute changes from baseline. BA-FMD will be determined using high-resolution ultrasonography and analyzed with a commercially available software package. An ultrasound probe will be placed 3-6 cm proximal to the antecubital crease on the right arm and a baseline image of the right brachial artery will be obtained. Following baseline, reactive hyperemia will be produced by inflating a rapid-inflating blood pressure cuff. Brachial artery diameter change will be measured for 2 minutes following 5-min of forearm blood flow occlusion.
Measured: EDD will be assessed at baseline and after 6 weeks of training
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2022
- Study start30 Jun 2023
- Primary completion6 May 2024
- Study completion6 May 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Diabetes Mellitus, Type 2Studies of the same condition, open and under way.
- More trials run by University of ArizonaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants will be randomly allocated using a 1:1 ratio to A) High-Intensity Training Group (75 % maximal inspiratory pressure) or B)Low-Intensity Training Group (15% maximal inspiratory pressure)
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 11 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Arizona
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Dallin Tavoian, PhD, Principal investigator, University of Arizona
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05643768
- Sponsor's protocol ID
- 00002239
- Acronym
- DIT
- Status last verified
- Jun 2024
- First submitted
- 30 Nov 2022
- Last updated
- 14 Jun 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: There is no plan to make IPD available
Publications
Craighead DH, Tavoian D, Freeberg KA, Mazzone JL, Vranish JR, DeLucia CM, Seals DR, Bailey EF. A multi-trial, retrospective analysis of the antihypertensive effects of high-resistance, low-volume inspiratory muscle strength training. J Appl Physiol (1985). 2022 Oct 1;133(4):1001-1010. doi: 10.1152/japplphysiol.00425.2022. Epub 2022 Sep 15.
PubMed 36107991
Study at a glance
From the registry record, last updated by the sponsor on 14 Jun 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Inspiratory Muscle Strength Training on Metabolic and Cardiovascular Health in Adults With Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT05643768
- Acronym / sponsor ID
- DIT / 00002239
- Conditions
- Diabetes Mellitus, Type 2, Hypertension
- Keywords
- insulin sensitivity, blood pressure, blood glucose, non-pharmacological, inspiratory resistance training
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 11 participants (actual)
- Lead sponsor
- University of ArizonaUniversity, hospital or other
- Study start
- 30 Jun 2023 (actual)
- Primary completion
- 6 May 2024 (actual)
- Study completion
- 6 May 2024 (actual)
- First posted
- 9 Dec 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This clinical research study will investigate the effects of 6 weeks of inspiratory muscle strength training on metabolic and cardiovascular outcomes in adults with recent-onset type 2 diabetes.
Detailed description
Type 2 diabetes mellitus (T2DM) is at epidemic proportions in the United States and worldwide. It is a chronic obesity-associated metabolic disorder characterized by glucose dysregulation combined with insulin resistance and beta-cell defects. First-line T2DM treatments include lifestyle remedies, such as dietary modifications and exercise. Exercise, whether aerobic and/or resistance training, increases whole-body insulin sensitivity and stimulates muscle glucose uptake independent of insulin. The acute effects of exercise on muscle in patients with abnormal glucose regulation produce immediate improvements in blood glucose levels. In addition, when exercise is repeated over time, adaptations occur that include more long-lasting increases in insulin sensitivity. The effects of traditional exercise on glycemic control and insulin sensitivity in patients with T2DM are well established. However, adherence to traditional exercise programs is low, in part, due to lack of time and physical discomfort, and new regimens for T2DM treatment are needed.
Recently, a novel time-efficient respiratory exercise called Inspiratory Muscle Strength Training (IMST) was developed. IMST is distinct from other traditional forms of exercise as it is only 5 minutes per session and performed on a hand-held device during stationary sitting or standing. Typically, IMST comprises 5 sets of 6 inspiratory maneuvers with 1-minute rests between sets. Previous studies demonstrate that 6 weeks of IMST improve systolic blood pressure (SBP), sympathetic nervous system activity, and endothelial function in healthy individuals, middle-aged and older people, and adults with obstructive sleep apnea. These BP-lowering effects of IMST are significant for reducing the risks of cardiovascular disease (CVD), the number one cause of death in people living with diabetes. IMST is safe and tolerable, with adherence rates >90% in diverse populations, and presents a manageable program for improving metabolic health in T2DM patients who have difficulty maintaining a traditional exercise program requiring a large amount of time and physical exertion. It is unknown if IMST, a highly-abbreviated respiratory exercise that is not physically demanding, has beneficial effects on glycemic control and insulin sensitivity, in combination with its improvements on BP measures, in patients with T2DM. The potential for IMST to exert metabolic benefits in diabetic patients warrants assessment
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
- Model description
- Participants will be randomly allocated using a 1:1 ratio to A) High-Intensity Training Group (75 % maximal inspiratory pressure) or B)Low-Intensity Training Group (15% maximal inspiratory pressure)
| Arm | Type | Receives |
|---|---|---|
| High-resistance IMST | Experimental | Behavioral: Inspiratory muscle strength training (IMST)30 breaths/day (5 sets of 6 breaths, one minute of rest between sets), 5 days/week, 6 weeks |
| Low-resistance IMST | Active comparator | Behavioral: Inspiratory muscle strength training (IMST)30 breaths/day (5 sets of 6 breaths, one minute of rest between sets), 5 days/week, 6 weeks |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- diagnosed with type 2 diabetes by physician
- fasting plasma glucose levels ≥126 mg/dl and ≤240 mg/dl
- systolic blood pressure between 120-169 mmHg
- stable dose of medication (three months on the same dose)
- weight stable in the prior 3 months (<3.0 kg weight change) and willing to remain weight stable throughout the study
Key exclusion criteria (14 listed)
- current smoker (including tobacco products, vaping devices, THC, etc…)
- have an uncontrolled medical condition (e.g., cancer)
- myocardial infarction or stroke within the previous 12 months
- performs regular aerobic exercise (>4 bouts/week)
- BMI ≥ 40 kg/m2
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Inspiratory muscle strength training (IMST)Also: inspiratory resistance training, vascular conditioning exercise, inspiratory muscle training30 breaths/day, 5 days/week, 6 weeks | Behavioural | High-resistance IMST, Low-resistance IMST |
Primary outcome
Change from baseline fasting blood plasma glucose after 6 weeks of IMST
Time frame: Blood plasma collected and analyzed at baseline and after 6 weeks of training
A blood sample will be collected after 12 hours of fasting. Blood and plasma will be separated and plasma glucose levels will be quantified.
Change from baseline fasting blood plasma Insulin after 6 weeks of IMST
Time frame: Blood plasma collected and analyzed at baseline and after 6 weeks of training
A blood sample will be collected after 12 hours of fasting. Blood and plasma will be separated and plasma insulin levels will be quantified.
Change from baseline insulin sensitivity after 6 weeks of IMST
Time frame: Blood plasma collected and analyzed at baseline and after 6 weeks of training
A blood sample will be collected after 12 hours of fasting. Insulin sensitivity will be calculated using the homeostatic model assessment of insulin resistance (HOMA-IR): (fasting serum insulin (mU/L) × fasting plasma glucose (mmol/L) × 22.5).
2 secondary outcomes
Change from baseline systolic blood pressure after 6 weeks of IMST
Time frame: Blood pressure will be assessed at baseline and after 6 weeks of training
Change from baseline Nitric Oxide-mediated Endothelial Dependent Dilation (EDD)
Time frame: EDD will be assessed at baseline and after 6 weeks of training
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 Jun 2024.
- Background: PubMed 36107991Craighead DH, Tavoian D, Freeberg KA, Mazzone JL, Vranish JR, DeLucia CM, Seals DR, Bailey EF. A multi-trial, retrospective analysis of the antihypertensive effects of high-resistance, low-volume inspiratory muscle strength training. J Appl Physiol (1985). 2022 Oct 1;133(4):1001-1010. doi: 10.1152/japplphysiol.00425.2022. Epub 2022 Sep 15.
- Individual participant dataSharing planned: No. There is no plan to make IPD available
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Dallin Tavoian, PhD principal investigator
University of Arizona
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Inspiratory muscle strength training (IMST) in people with Diabetes Mellitus, Type 2 and Hypertension, run by University of Arizona at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 14 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 14 Jun 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from baseline fasting blood plasma glucose after 6 weeks of IMST (time frame: Blood plasma collected and analyzed at baseline and after 6 weeks of training). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05643768, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Jun 2024.