Ignite Creation Date:
2025-12-24 @ 2:33 PM
Ignite Modification Date:
2026-01-01 @ 2:25 PM
Study NCT ID:
NCT06881459
Status:
COMPLETED
Last Update Posted:
2025-09-09
First Post:
2025-03-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of Oxytocin on the Alpha Cell Response to Hypoglycaemia in Patients With Type 1 Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003922', 'term': 'Diabetes Mellitus, Type 1'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D010121', 'term': 'Oxytocin'}], 'ancestors': [{'id': 'D010909', 'term': 'Pituitary Hormones, Posterior'}, {'id': 'D010907', 'term': 'Pituitary 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'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR'], 'maskingDescription': 'The randomized order of infusions is blinded to both participant and investigator'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'Randomized, double-blinded, single-arm study. Each participant goes through two experimental days in a randomized order, acting as their own controls'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 16}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2025-03-25', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-03', 'completionDateStruct': {'date': '2025-09-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2025-09-08', 'studyFirstSubmitDate': '2025-03-11', 'studyFirstSubmitQcDate': '2025-03-11', 'lastUpdatePostDateStruct': {'date': '2025-09-09', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-03-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-07-18', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Glucagon secretion', 'timeFrame': 'From time 30 to time 90 minutes', 'description': 'Glucagon secretion, measured as the difference in plasma glucagon response to hypoglycaemia (as assessed by baseline subtracted area under curve (bsAUC)) during the hypoglycaemic clamp, between study days with oxytocin and with placebo'}], 'secondaryOutcomes': [{'measure': 'Glucagon during recovery', 'timeFrame': 'From time 90 minutes to time 135 minutes', 'description': 'measured as difference in glucagon bsAUC in the recovery phase'}, {'measure': 'Glucagon during the entire period', 'timeFrame': 'From time 0 minutes to time 135 minutes', 'description': 'measured as difference in glucagon bsAUC in the intire period'}, {'measure': 'Glucose infusion', 'timeFrame': 'From time 0 minutes to time 135 minutes', 'description': 'measured as the total amount of glucose infused'}, {'measure': 'Insulin', 'timeFrame': 'From time 0 minutes to time 135 minutes', 'description': 'measured as the difference in circulating levels of insulin between study days'}, {'measure': 'c-peptide', 'timeFrame': 'From time 0 minutes to time 135 minutes', 'description': 'measured as the difference in circulating levels of c-peptide between study days'}, {'measure': 'Epinephrine', 'timeFrame': 'From time 0 minutes to time 135 minutes', 'description': 'measured as the difference in circulating levels of epinephrine between study days'}, {'measure': 'Norepinephrine', 'timeFrame': 'From time 0 minutes to time 135 minutes', 'description': 'measured as the difference in circulating levels of norepinephrine between study days'}, {'measure': 'Cortisol', 'timeFrame': 'From time 0 minutes to time 135 minutes', 'description': 'measured as the difference in circulating levels of cortisol between study days'}, {'measure': 'Cross-linked C-telopeptide of type I collagen( CTX)', 'timeFrame': 'From time 0 minutes to time 135 minutes', 'description': 'measured as the difference in circulating levels of CTX between study days'}, {'measure': 'Procollagen type I N-terminal propeptide (P1NP)', 'timeFrame': 'From time 0 minutes to time 135 minutes', 'description': 'measured as the difference in circulating levels of P1NP between study days'}, {'measure': 'Growth Hormone (GH)', 'timeFrame': 'From time 0 minutes to time 135 minutes', 'description': 'measured as the difference in circulating levels of GH between study days'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Type 1 Diabetes']}, 'descriptionModule': {'briefSummary': 'Investigating the effect of oxytocin on pancreatic endocrine functions by determining glucagon secretion during hypoglycemia in participants with type 1 diabetes.', 'detailedDescription': 'Glucagonotropic effects of oxytocin will be examined in 16 participants with type 1 diabetes, during a hypoglycaemic clamp with concomitant intravenous infusion of synthetic oxytocin or placebo in a randomised, double-blinded design. This will determine the effect of oxytocin on the glucagon response to hypoglycemia. Additional changes in plasma/serum concentrations of insulin, C-peptide, glucose, glucose-dependent insulinotropic polypeptid (GIP) and glucagon-like peptide 1 (GLP-1) will be assessed.'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Body mass index from 19 to 30 kg/m2\n* T1D (diagnosed according to the criteria of the World Health Organization) with HbA1c \\<69 mmol/mol (\\<8.5%)\n* T1D duration of 3-30 years\n* C-peptide negative (stimulated C-peptide ≤ 100 pmol/l)\n* Treatment with a stable basal-bolus or insulin pump regimen for ≥3 months\n\nExclusion Criteria:\n\n* Anaemia (haemoglobin below normal range)\n* Liver disease (alanine aminotransferase (ALT) and/or aspartate aminotransferase (AST) \\>2 times normal values) or present hepatobiliary and/or gastrointestinal disorder(s)\n* Kidney disease (serum creatinine above normal range)\n* Late microvascular complications except mild non-proliferative retinopathy\n* Regular tobacco smoking or use of other nicotine-containing products\n* Long QTc on electrocardiogram (ECG) at screening (≥0.45 seconds)\n* Pituitary gland disease\n* Treatment with any glucose-lowering drugs besides insulin\n* Any ongoing medication or physical or psychological condition that the investigator feels would interfere with trial participation'}, 'identificationModule': {'nctId': 'NCT06881459', 'acronym': 'GLOXY-2', 'briefTitle': 'The Effect of Oxytocin on the Alpha Cell Response to Hypoglycaemia in Patients With Type 1 Diabetes', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Gentofte, Copenhagen'}, 'officialTitle': 'The Effect of Oxytocin on the Alpha Cell Response to Hypoglycaemia in Patients With Type 1 Diabetes', 'orgStudyIdInfo': {'id': 'GLOXY-2'}, 'secondaryIdInfos': [{'id': 'H-24080204', 'type': 'OTHER', 'domain': 'The Danish Health Research Ethics Committee system'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Infusion of placebo', 'description': 'Placebo', 'interventionNames': ['Other: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Infusion of oxytocin', 'description': 'Infusion of oxytocin', 'interventionNames': ['Drug: Oxytocin']}], 'interventions': [{'name': 'Placebo', 'type': 'OTHER', 'description': 'Saline', 'armGroupLabels': ['Infusion of placebo']}, {'name': 'Oxytocin', 'type': 'DRUG', 'description': 'Oxytocin', 'armGroupLabels': ['Infusion of oxytocin']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2900', 'city': 'Hellerup', 'country': 'Denmark', 'facility': 'Center for Clinical Metabolic Research, Gentofte Hospital', 'geoPoint': {'lat': 55.73204, 'lon': 12.57093}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Gentofte, Copenhagen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Associate Professor', 'investigatorFullName': 'Asger Lund, MD', 'investigatorAffiliation': 'University Hospital, Gentofte, Copenhagen'}}}}