Clinical trial NCT05643768: Inspiratory Muscle Strength Training in Adults With Type 2 Diabetes
Official title: Effects of Inspiratory Muscle Strength Training on Metabolic and Cardiovascular Health in Adults With Type 2 Diabetes
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Diabetes Mellitus, Type 2
Hypertension
Keywords: insulin sensitivity
blood pressure
blood glucose
non-pharmacological
inspiratory resistance training
Lead sponsor: University of Arizona
Sponsor class: OTHER
First posted: 2022-12-09
Enrollment: 11
Sex: ALL
Minimum age (years): 18
Maximum age (years): 65
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention 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)
Primary purpose: BASIC_SCIENCE

Brief 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.

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

Eligibility criteria: Inclusion Criteria:

* 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

Exclusion Criteria:

* 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
* 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)

Primary outcomes:
measure: Change from baseline fasting blood plasma glucose after 6 weeks of IMST
timeFrame: Blood plasma collected and analyzed at baseline and after 6 weeks of training
measure: Change from baseline fasting blood plasma Insulin after 6 weeks of IMST
timeFrame: Blood plasma collected and analyzed at baseline and after 6 weeks of training
measure: Change from baseline insulin sensitivity after 6 weeks of IMST
timeFrame: Blood plasma collected and analyzed at baseline and after 6 weeks of training
Secondary outcomes:
measure: Change from baseline systolic blood pressure after 6 weeks of IMST
timeFrame: Blood pressure will be assessed at baseline and after 6 weeks of training
measure: Change from baseline Nitric Oxide-mediated Endothelial Dependent Dilation (EDD)
timeFrame: EDD will be assessed at baseline and after 6 weeks of training
Other outcomes:
measure: Change from baseline proteomic analysis
timeFrame: Proteomics will be performed at baseline and after 6 weeks of training
Locations:
city: Tucson
country: United States
facility: Arizona Respiratory and Neurophysiology Laboratory
state: Arizona
Study officials:
affiliation: University of Arizona
name: Dallin Tavoian, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.