Inspiratory Muscle Strength Training in Adults With Type 2 Diabetes

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

11 participants

Study Classification

INTERVENTIONAL

Study Start Date

2023-06-30

Study Completion Date

2024-05-06

Brief Summary

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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.

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Detailed Description

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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

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Diabetes Mellitus, Type 2 Hypertension

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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 Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

This is a randomized trial and participants will be blinded to their allocation group.

Study Groups

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High-resistance IMST

30 breaths/day (5 sets of 6 breaths, one minute of rest between sets), 5 days/week, 6 weeks

Group Type EXPERIMENTAL

Inspiratory muscle strength training (IMST)

Intervention Type BEHAVIORAL

30 breaths/day, 5 days/week, 6 weeks

Low-resistance IMST

30 breaths/day (5 sets of 6 breaths, one minute of rest between sets), 5 days/week, 6 weeks

Group Type ACTIVE_COMPARATOR

Inspiratory muscle strength training (IMST)

Intervention Type BEHAVIORAL

30 breaths/day, 5 days/week, 6 weeks

Interventions

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Inspiratory muscle strength training (IMST)

30 breaths/day, 5 days/week, 6 weeks

Intervention Type BEHAVIORAL

Other Intervention Names

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inspiratory resistance training vascular conditioning exercise inspiratory muscle training

Eligibility Criteria

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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)

Minimum Eligible Age

18 Years

Maximum Eligible Age

65 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No