Ignite Creation Date:
2025-12-24 @ 11:28 PM
Ignite Modification Date:
2026-02-25 @ 6:33 PM
Study NCT ID:
NCT01847456
Status:
COMPLETED
Last Update Posted:
2013-12-23
First Post:
2013-04-28
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Influence of Brain Insulin Sensitivity on Peripheral Insulin Sensitivity
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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D007328', 'term': 'Insulin'}, {'id': 'D059085', 'term': 'Nasal Sprays'}], 'ancestors': [{'id': 'D011384', 'term': 'Proinsulin'}, {'id': 'D061385', 'term': 'Insulins'}, {'id': 'D010187', 'term': 'Pancreatic Hormones'}, {'id': 'D036361', 'term': 'Peptide Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D010455', 'term': 'Peptides'}, {'id': 'D000602', 'term': 'Amino Acids, Peptides, and Proteins'}, {'id': 'D000336', 'term': 'Aerosols'}, {'id': 'D003102', 'term': 'Colloids'}, {'id': 'D045424', 'term': 'Complex Mixtures'}, {'id': 'D004304', 'term': 'Dosage Forms'}, {'id': 'D004364', 'term': 'Pharmaceutical Preparations'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'SINGLE', 'whoMasked': ['PARTICIPANT']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2013-04'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2013-12', 'lastUpdateSubmitDate': '2013-12-20', 'studyFirstSubmitDate': '2013-04-28', 'studyFirstSubmitQcDate': '2013-05-03', 'lastUpdatePostDateStruct': {'date': '2013-12-23', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2013-05-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2013-11', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Insulin sensitivity as measured by clamp', 'timeFrame': '45 minutes to 120 minutes post nasal spray', 'description': 'We will measure insulin sensitivity by hyperinsulinemic euglycemic clamp before and after nasal spray application. We will compare the post-spray insulin sensitivity between the two condition (insulin nasal spray vs placebo nasal spray). Furthermore, we will compare insulin sensitivity before and after nasal insulin application.'}], 'secondaryOutcomes': [{'measure': 'Autonomous nervous system activity', 'timeFrame': '45 to 120 minutes post spray', 'description': 'Activity of the autonomous nervous system will be estimated by heart rate variability in ECG. We will compare the post-spray autonomous nervous system activity between the two condition (insulin nasal spray vs placebo nasal spray). Furthermore, we will compare autonomous nervous system activity before and after nasal insulin application.'}]}, 'conditionsModule': {'keywords': ['whole body insulin sensitivity', 'insulin action in the brain'], 'conditions': ['Insulin Sensitivity']}, 'referencesModule': {'references': [{'pmid': '25028522', 'type': 'DERIVED', 'citation': 'Heni M, Wagner R, Kullmann S, Veit R, Mat Husin H, Linder K, Benkendorff C, Peter A, Stefan N, Haring HU, Preissl H, Fritsche A. Central insulin administration improves whole-body insulin sensitivity via hypothalamus and parasympathetic outputs in men. Diabetes. 2014 Dec;63(12):4083-8. doi: 10.2337/db14-0477. Epub 2014 Jul 15.'}]}, 'descriptionModule': {'briefSummary': 'The researchers will investigate if brain insulin action influences peripheral insulin sensitivity in healthy humans.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '35 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* BMI \\< 28 kg/m2\n* normal HbA1c\n* healthy volunteers\n\nExclusion Criteria:\n\n* Heparin induced thrombocytopenia (HIT)\n* metal implants\n* cardial diseases\n* anemia\n* patients taking any kind of drugs'}, 'identificationModule': {'nctId': 'NCT01847456', 'briefTitle': 'Influence of Brain Insulin Sensitivity on Peripheral Insulin Sensitivity', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital Tuebingen'}, 'officialTitle': 'Influence of Brain Insulin Sensitivity on Peripheral Insulin Sensitivity', 'orgStudyIdInfo': {'id': 'SFB 997 A01 WP7'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'insulin nasal spray', 'description': '160 Units of human insulin as nasal spray', 'interventionNames': ['Drug: human insulin as nasal spray']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo nasal spray', 'description': 'Nasalspray containing placebo solution', 'interventionNames': ['Drug: Placebo']}], 'interventions': [{'name': 'human insulin as nasal spray', 'type': 'DRUG', 'armGroupLabels': ['insulin nasal spray']}, {'name': 'Placebo', 'type': 'DRUG', 'armGroupLabels': ['Placebo nasal spray']}]}, 'contactsLocationsModule': {'locations': [{'zip': '72074', 'city': 'Tübingen', 'country': 'Germany', 'facility': 'University of Tuebingen, Internal medicine IV', 'geoPoint': {'lat': 48.52266, 'lon': 9.05222}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital Tuebingen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor of Medicine', 'investigatorFullName': 'andreas fritsche', 'investigatorAffiliation': 'University Hospital Tuebingen'}}}}