Effect of Breathing Maneuvers on Peripheral Glucose Metabolism (RESPI01)

June 16, 2020 updated by: University Hospital Tuebingen

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).

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

16

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
      • Tübingen, Germany, 72076
        • University of Tuebingen, Department of Internal Medicine IV

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 65 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Male

Description

Inclusion Criteria:

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

Exclusion Criteria:

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Basic Science
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: deep breathing
Other: deep breathing
Deep breathing maneuver to increase parasympathetic nerve activity
No Intervention: normal breathing

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Whole body insulin sensitivity
Time Frame: 0-120 min
Insulin sensitivity will be assessed by a 75g OGTT
0-120 min

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Insulin secretion
Time Frame: 0-120 min
Insulin secretion will be assessed by a 75g OGTT
0-120 min
Glucose tolerance
Time Frame: 0-120 min
Glucose tolerance will be assessed by a 75g OGTT
0-120 min
Resting energy expenditure
Time Frame: 140-160 min after start of breathing maneuver
Resting energy expenditure will be assessed by indirect calorimetry
140-160 min after start of breathing maneuver
Heart rate variability
Time Frame: -35 - 120 min
Heart rate variability will be assessed from continuous ecg recordings
-35 - 120 min

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University Hospital Tuebingen

Investigators

  • Principal Investigator: Martin Heni, MD, University Hospital Tübingen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

November 1, 2019

Primary Completion (Actual)

March 1, 2020

Study Completion (Actual)

April 1, 2020

Study Registration Dates

First Submitted

October 31, 2019

First Submitted That Met QC Criteria

October 31, 2019

First Posted (Actual)

November 5, 2019

Study Record Updates

Last Update Posted (Actual)

June 17, 2020

Last Update Submitted That Met QC Criteria

June 16, 2020

Last Verified

October 1, 2019

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • 039/2019B02

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

No

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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