Effect of Breathing Maneuvers on Peripheral Glucose Metabolism (RESPI01)
Primary Purpose
Vagus Nerve Stimulation, Insulin Sensitivity, Deep Breathing Maneuver
Status
Completed
Phase
Not Applicable
Locations
Germany
Study Type
Interventional
Intervention
deep breathing
Sponsored by
About this trial
This is an interventional basic science trial for Vagus Nerve Stimulation
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
Sites / Locations
- University of Tuebingen, Department of Internal Medicine IV
Arms of the Study
Arm 1
Arm 2
Arm Type
Active Comparator
No Intervention
Arm Label
deep breathing
normal breathing
Arm Description
Outcomes
Primary Outcome Measures
Whole body insulin sensitivity
Insulin sensitivity will be assessed by a 75g OGTT
Secondary Outcome Measures
Insulin secretion
Insulin secretion will be assessed by a 75g OGTT
Glucose tolerance
Glucose tolerance will be assessed by a 75g OGTT
Resting energy expenditure
Resting energy expenditure will be assessed by indirect calorimetry
Heart rate variability
Heart rate variability will be assessed from continuous ecg recordings
Full Information
NCT ID
NCT04150627
First Posted
October 31, 2019
Last Updated
June 16, 2020
Sponsor
University Hospital Tuebingen
1. Study Identification
Unique Protocol Identification Number
NCT04150627
Brief Title
Effect of Breathing Maneuvers on Peripheral Glucose Metabolism
Acronym
RESPI01
Official Title
Effect of Breathing Maneuvers on Peripheral Glucose Metabolism
Study Type
Interventional
2. Study Status
Record Verification Date
October 2019
Overall Recruitment Status
Completed
Study Start Date
November 1, 2019 (Actual)
Primary Completion Date
March 1, 2020 (Actual)
Study Completion Date
April 1, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University Hospital Tuebingen
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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).
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Vagus Nerve Stimulation, Insulin Sensitivity, Deep Breathing Maneuver
7. Study Design
Primary Purpose
Basic Science
Study Phase
Not Applicable
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
16 (Actual)
8. Arms, Groups, and Interventions
Arm Title
deep breathing
Arm Type
Active Comparator
Arm Title
normal breathing
Arm Type
No Intervention
Intervention Type
Other
Intervention Name(s)
deep breathing
Intervention Description
Deep breathing maneuver to increase parasympathetic nerve activity
Primary Outcome Measure Information:
Title
Whole body insulin sensitivity
Description
Insulin sensitivity will be assessed by a 75g OGTT
Time Frame
0-120 min
Secondary Outcome Measure Information:
Title
Insulin secretion
Description
Insulin secretion will be assessed by a 75g OGTT
Time Frame
0-120 min
Title
Glucose tolerance
Description
Glucose tolerance will be assessed by a 75g OGTT
Time Frame
0-120 min
Title
Resting energy expenditure
Description
Resting energy expenditure will be assessed by indirect calorimetry
Time Frame
140-160 min after start of breathing maneuver
Title
Heart rate variability
Description
Heart rate variability will be assessed from continuous ecg recordings
Time Frame
-35 - 120 min
10. Eligibility
Sex
Male
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
65 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Martin Heni, MD
Organizational Affiliation
University Hospital Tübingen
Official's Role
Principal Investigator
Facility Information:
Facility Name
University of Tuebingen, Department of Internal Medicine IV
City
Tübingen
ZIP/Postal Code
72076
Country
Germany
12. IPD Sharing Statement
Plan to Share IPD
No
Learn more about this trial
Effect of Breathing Maneuvers on Peripheral Glucose Metabolism
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