Ignite Creation Date:
2025-12-24 @ 12:11 PM
Ignite Modification Date:
2026-01-03 @ 11:07 PM
Study NCT ID:
NCT02870361
Status:
COMPLETED
Last Update Posted:
2018-05-08
First Post:
2016-08-09
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Influence of Central Nervous Insulin Sensitivity on Insulin Secretion
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 15}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-05', 'completionDateStruct': {'date': '2018-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-05-02', 'studyFirstSubmitDate': '2016-08-09', 'studyFirstSubmitQcDate': '2016-08-16', 'lastUpdatePostDateStruct': {'date': '2018-05-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2016-08-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2018-02', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Insulin secretion assessed as serum C-peptide levels during a hyperglycemic clamp', 'timeFrame': '0-10 min during hyperglycemic clamp and 10-90 min during hyperglycemic clamp'}], 'secondaryOutcomes': [{'measure': 'Correlation with brain insulin sensitivity', 'timeFrame': '15-30 minutes post insulin nasal spray', 'description': 'Correlation of regional brain insulin sensitivity with the change of pancreatic insulin secretion due to central action of insulin. Changes in regional cerebral blood flow from before to after intranasal insulin administration will be assessed by functional magnetresonance imaging (fMRI)'}, {'measure': 'Differential effects in lean and overweight', 'timeFrame': '0-10 min during hyperglycemic clamp and 10-90 min during hyperglycemic clamp', 'description': 'Differences in the effect of nasal insulin versus placebo on C-peptide levels during a hyperglycemic clamp between lean and overweight men will be assessed.'}, {'measure': 'Correlation with autonomous nervous system activity', 'timeFrame': '10 - 150 minutes post nasal spray', 'description': 'Correlation of the change in pancreatic insulin secretion by central insulin action with the simultaneous change of the autonomous nervous system (measured by heart rate variability).'}, {'measure': 'Peripheral insulin sensitivity', 'timeFrame': '10-90 min and 70-90 min during hyperglycemic clamp', 'description': 'Effect of nasal insulin versus placebo on peripheral insulin sensitivity assessed by hyperglycemic hyperinsulinemic clamp.'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Insulin Secretion']}, 'referencesModule': {'references': [{'pmid': '31689708', 'type': 'DERIVED', 'citation': 'Heni M, Wagner R, Willmann C, Jaghutriz BA, Vosseler A, Kubler C, Hund V, Scheffler K, Peter A, Haring HU, Preissl H, Kullmann S, Fritsche A. Insulin Action in the Hypothalamus Increases Second-Phase Insulin Secretion in Humans. Neuroendocrinology. 2020;110(11-12):929-937. doi: 10.1159/000504551. Epub 2019 Nov 5.'}]}, 'descriptionModule': {'briefSummary': 'Insulin resistance is a central pathophysiological component of type 2 diabetes and is associated with a high risk of cardiovascular disease. The tissue in which it manifests are mainly muscle, liver, and adipose tissue. Since the transport of glucose to the brain is independent of insulin, this organ has traditionally not been studied in this regard. In animal experiments, however, knockout of the insulin receptor in the brain leads to obesity and peripheral insulin resistance. This finding of insulin action in the brain could also be confirmed in human studies.\n\nThe investigators intend to investigate whether central nervous insulin action affects insulin secretion in humans. For this purpose, nasal insulin and placebo are administered 15 minutes before a hyperglycemic hyperinsulinemic clamps, which stimulate insulin secretion. Insulin sensitivity of the brain is measured by a an established protocol with functional magnetic resonance imaging before and after nasal insulin administration.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* HbA1c ≤6.0%\n* normal glucose tolerance during 75g oral glucose tolerance test (OGTT)\n\nExclusion Criteria:\n\n* Not removable metal parts in or on the body\n* manifest cardiovascular disease\n* claustrophobia\n* recent surgery (less than 3 months)\n* Simultaneous participation in other studies\n* Acute disease or infection within the last 4 weeks\n* neurological and psychiatric disorders\n* treatment with centrally acting drugs\n* hemoglobin Hb \\<13g / dl\n* Hypersensitivity to any of the substances used'}, 'identificationModule': {'nctId': 'NCT02870361', 'briefTitle': 'Influence of Central Nervous Insulin Sensitivity on Insulin Secretion', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital Tuebingen'}, 'officialTitle': 'Einfluss Der zentralnervösen Insulinsensitivität Auf Die Insulinsekretion', 'orgStudyIdInfo': {'id': '086/2016BO1'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Insulin nasal spray', 'description': '160 Units of human insulin as nasal spray', 'interventionNames': ['Drug: intranasal insulin']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo nasal spray', 'description': 'Nasal spray containing placebo solution', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'intranasal insulin', 'type': 'DRUG', 'armGroupLabels': ['Insulin nasal spray']}, {'name': 'Placebo', 'type': 'DRUG', 'armGroupLabels': ['Placebo nasal spray']}]}, '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 Tuebingen'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital Tuebingen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}