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Completed

NCT Number: NCT04150627

Effect of Breathing Maneuvers on Peripheral Glucose Metabolism

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).

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Key information

Age range

18 year–65 year

Sex eligibility

Male

Study type

Interventional

Phase

Not applicable

Primary location

University of Tuebingen, Department of Internal Medicine IV

Tübingen, 72076, Germany

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

deep breathing

Other

Deep breathing maneuver to increase parasympathetic nerve activity

Primary outcomes

  1. Whole body insulin sensitivity

    Time frame: 0-120 min

    Insulin sensitivity will be assessed by a 75g OGTT

Secondary outcomes

  1. Insulin secretion

    Time frame: 0-120 min

    Insulin secretion will be assessed by a 75g OGTT

  2. Glucose tolerance

    Time frame: 0-120 min

    Glucose tolerance will be assessed by a 75g OGTT

  3. Resting energy expenditure

    Time frame: 140-160 min after start of breathing maneuver

    Resting energy expenditure will be assessed by indirect calorimetry

  4. Heart rate variability

    Time frame: -35 - 120 min

    Heart rate variability will be assessed from continuous ecg recordings

Sponsors and collaborators

Lead sponsor

University Hospital Tuebingen

Other

Registry information

Acronym: RESPI01

Important dates

Study start
2019
Primary completion
2020
Study completion
2020
First posted
Nov 5, 2019
Registry last updated
Jun 17, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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