Inspiratory Muscle Strength Training in Adults With Type 2 Diabetes

NCT05643768 | Completed

• 1 other identifier: 00002239
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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.

Conditions

Diabetes Mellitus, Type 2; Hypertension

Keywords

insulin sensitivity; blood pressure; blood glucose; non-pharmacological; inspiratory resistance training

Outcome Measures

Primary Outcomes (3)

• 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.

  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.

  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).

  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

  Blood pressure will be assessed at baseline and after 6 weeks of training

• Change from baseline Nitric Oxide-mediated Endothelial Dependent Dilation (EDD)

  EDD will be assessed at baseline and after 6 weeks of training

Other Outcomes (1)

• Change from baseline proteomic analysis

  Proteomics will be performed at baseline and after 6 weeks of training

Study Arms (2)

High-resistance IMST

EXPERIMENTAL

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

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

Behavioral: Inspiratory muscle strength training (IMST)

Interventions

Inspiratory muscle strength training (IMST) BEHAVIORAL

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

Also known as: inspiratory resistance training, vascular conditioning exercise, inspiratory muscle training

High-resistance IMST; Low-resistance IMST

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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)

Sponsors & Collaborators

• University of Arizona: lead

Study Sites (1)

Arizona Respiratory and Neurophysiology Laboratory

Tucson, Arizona, 85724, United States

Location

Related Publications (1)

• 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.

  PMID: 36107991 BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2; Hypertension; Insulin Resistance

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Vascular Diseases; Cardiovascular Diseases; Hyperinsulinism

Study Officials

• Dallin Tavoian, PhD

  University of Arizona

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Masking Details: This is a randomized trial and participants will be blinded to their allocation group.
• Purpose: BASIC SCIENCE
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: 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)

Study Record Dates

• First Submitted: November 30, 2022
• First Posted: December 9, 2022
• Study Start: June 30, 2023
• Primary Completion: May 6, 2024
• Study Completion: May 6, 2024
• Last Updated: June 14, 2024

Record last verified: 2024-06

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)