Ignite Creation Date:
2025-12-25 @ 5:07 AM
Ignite Modification Date:
2026-02-26 @ 8:12 PM
Study NCT ID:
NCT04150627
Status:
COMPLETED
Last Update Posted:
2020-06-17
First Post:
2019-10-31
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of Breathing Maneuvers on Peripheral Glucose Metabolism
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D007333', 'term': 'Insulin Resistance'}], 'ancestors': [{'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-11-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-10', 'completionDateStruct': {'date': '2020-04-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-06-16', 'studyFirstSubmitDate': '2019-10-31', 'studyFirstSubmitQcDate': '2019-10-31', 'lastUpdatePostDateStruct': {'date': '2020-06-17', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-11-05', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2020-03-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Whole body insulin sensitivity', 'timeFrame': '0-120 min', 'description': 'Insulin sensitivity will be assessed by a 75g OGTT'}], 'secondaryOutcomes': [{'measure': 'Insulin secretion', 'timeFrame': '0-120 min', 'description': 'Insulin secretion will be assessed by a 75g OGTT'}, {'measure': 'Glucose tolerance', 'timeFrame': '0-120 min', 'description': 'Glucose tolerance will be assessed by a 75g OGTT'}, {'measure': 'Resting energy expenditure', 'timeFrame': '140-160 min after start of breathing maneuver', 'description': 'Resting energy expenditure will be assessed by indirect calorimetry'}, {'measure': 'Heart rate variability', 'timeFrame': '-35 - 120 min', 'description': 'Heart rate variability will be assessed from continuous ecg recordings'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Vagus Nerve Stimulation', 'Insulin Sensitivity', 'Deep Breathing Maneuver']}, 'descriptionModule': {'briefSummary': '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.\n\nDeep 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.\n\nThe 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.\n\nTo 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).'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* HbA1c \\<6.5%\n* Must be able to understand the explanations of the study and the instructions\n\nExclusion Criteria:\n\n* Any relevant (according to investigator's judgment) cardiovascular disease\n* Neurological and psychiatric disorders\n* Diabetes mellitus\n* Asthma"}, 'identificationModule': {'nctId': 'NCT04150627', 'acronym': 'RESPI01', 'briefTitle': 'Effect of Breathing Maneuvers on Peripheral Glucose Metabolism', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital Tuebingen'}, 'officialTitle': 'Effect of Breathing Maneuvers on Peripheral Glucose Metabolism', 'orgStudyIdInfo': {'id': '039/2019B02'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'deep breathing', 'interventionNames': ['Other: deep breathing']}, {'type': 'NO_INTERVENTION', 'label': 'normal breathing'}], 'interventions': [{'name': 'deep breathing', 'type': 'OTHER', 'description': 'Deep breathing maneuver to increase parasympathetic nerve activity', 'armGroupLabels': ['deep breathing']}]}, 'contactsLocationsModule': {'locations': [{'zip': '72076', 'city': 'Tübingen', 'country': 'Germany', 'facility': 'University of Tuebingen, Department of Internal Medicine IV', 'geoPoint': {'lat': 48.52266, 'lon': 9.05222}}], 'overallOfficials': [{'name': 'Martin Heni, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital Tübingen'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital Tuebingen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}