Effect of Breathing Maneuvers on Peripheral Glucose Metabolism

NCT04150627 | Completed

• 1 other identifier: 039/2019B02
• Study Type: interventional
• Target: 16
• Locations: 1 country
• Sites: 1

Brief Summary

Two important mechanisms play a major role in the pathogenesis of type 2 diabetes: insulin resistance of the target tissues and the impaired insulin secretion from pancreatic β-cells. Postprandial factors (such as insulin) are perceived by the human brain and induce signals that regulate glucose metabolism via the parasympathetic nervous system. Deep breathing exercise can increase parasympathetic nerve activity. Heart rate variability (HRV) in healthy people can be significantly increased by deep breathing maneuvers, indicating a shift from sympathetic activity to parasympathetic activity. The hypothesis is that this postprandial shift results in a change in peripheral glucose metabolism. In turn, the increased parasympathetic activity could potentially result in a change in postprandial insulin sensitivity or secretion. To test this hypothesis, this study investigates the effect of deep breathing exercise versus normal breathing on insulin sensitivity, on insulin secretion, glucose tolerance, resting energy expenditure, and on parasympathetic tone (analysis of heart rate variability).

Conditions

Vagus Nerve Stimulation; Insulin Sensitivity; Deep Breathing Maneuver

Outcome Measures

Primary Outcomes (1)

• Whole body insulin sensitivity

  Insulin sensitivity will be assessed by a 75g OGTT

  0-120 min

Secondary Outcomes (4)

• Insulin secretion

  0-120 min

• Glucose tolerance

  0-120 min

• Resting energy expenditure

  140-160 min after start of breathing maneuver

• Heart rate variability

  -35 - 120 min

Study Arms (2)

deep breathing

ACTIVE COMPARATOR

Other: deep breathing

normal breathing

NO INTERVENTION

Interventions

deep breathing OTHER

Deep breathing maneuver to increase parasympathetic nerve activity

deep breathing

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: male
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• HbA1c \<6.5%
• Must be able to understand the explanations of the study and the instructions

You may not qualify if:

• Any relevant (according to investigator's judgment) cardiovascular disease
• Neurological and psychiatric disorders
• Diabetes mellitus
• Asthma

Sponsors & Collaborators

• University Hospital Tuebingen: lead

Study Sites (1)

University of Tuebingen, Department of Internal Medicine IV

Tübingen, 72076, Germany

Location

MeSH Terms

Conditions

Insulin Resistance

Condition Hierarchy (Ancestors)

Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Study Officials

• Martin Heni, MD

  University Hospital Tübingen

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: October 31, 2019
• First Posted: November 5, 2019
• Study Start: November 1, 2019
• Primary Completion: March 1, 2020
• Study Completion: April 1, 2020
• Last Updated: June 17, 2020

Record last verified: 2019-10

Data Sharing

• IPD Sharing: Will not share

Locations

DE (1)