Effect of Breathing Maneuvers on Peripheral Glucose Metabolism

NCT ID: NCT04150627

Last Updated: 2020-06-17

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 16 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2019-11-01
• Study Completion Date: 2020-04-01

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

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: CROSSOVER
• Primary Study Purpose: BASIC_SCIENCE
• Blinding Strategy: NONE

Study Groups

deep breathing

Group Type: ACTIVE_COMPARATOR

deep breathing

Intervention Type: OTHER

Deep breathing maneuver to increase parasympathetic nerve activity

normal breathing

Group Type: NO_INTERVENTION

No interventions assigned to this group

Interventions

deep breathing

Deep breathing maneuver to increase parasympathetic nerve activity

Intervention Type: OTHER

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 65 Years
• Eligible Sex: MALE
• Accepts Healthy Volunteers: Yes

Sponsors

University Hospital Tuebingen

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Martin Heni, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital Tübingen

Locations

University of Tuebingen, Department of Internal Medicine IV

Tübingen, , Germany

Countries

Germany

Other Identifiers

039/2019B02

Identifier Type: -

Identifier Source: org_study_id