Ignite Creation Date:
2025-12-25 @ 5:03 AM
Ignite Modification Date:
2026-01-28 @ 11:48 PM
Study NCT ID:
NCT03734718
Status:
COMPLETED
Last Update Posted:
2020-01-27
First Post:
2018-10-22
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Role of Glucose-Dependent Insulinotropic Polypeptide in the Pathological Glucose Homeostasis Of Type 1 Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24', 'submissionTracking': {'submissionInfos': [{'resetDate': '2025-03-06', 'releaseDate': '2025-02-14'}], 'estimatedResultsFirstSubmitDate': '2025-02-14'}}, 'conditionBrowseModule': {'meshes': [{'id': 'D003922', 'term': 'Diabetes Mellitus, Type 1'}, {'id': 'D007003', 'term': 'Hypoglycemia'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001327', 'term': 'Autoimmune Diseases'}, {'id': 'D007154', 'term': 'Immune System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR'], 'maskingDescription': 'The peptides/placebo is prepared, in a randomized fashion, by a laboratory assistant.'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER', 'interventionModelDescription': 'placebo-controlled, double-blinded, cross-over study'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 20}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2019-06-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-01', 'completionDateStruct': {'date': '2019-12-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-01-23', 'studyFirstSubmitDate': '2018-10-22', 'studyFirstSubmitQcDate': '2018-11-06', 'lastUpdatePostDateStruct': {'date': '2020-01-27', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-11-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2019-12-12', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Blood glucose', 'timeFrame': 'an average of 6 days', 'description': 'Time spent in hypoglycemia, near-normoglycemia and hyperglycemia'}], 'secondaryOutcomes': [{'measure': 'Incretin hormones', 'timeFrame': 'Evaluated at experimental day 0,1 and 6 of each intervention', 'description': 'Incretin hormones GLP-1 and GIP. Incremental and total area under the Concentration-Time Curve'}, {'measure': 'Free fatty acids (FFA)', 'timeFrame': 'Evaluated at experimental day 0,1 and 6 of each intervention', 'description': 'Incremental and total area under the Concentration-Time Curve'}, {'measure': 'Fat mRNA', 'timeFrame': 'At day 6, and 10 of the study', 'description': 'mRNA analysis of fat biopsies'}, {'measure': 'Fat Protein content', 'timeFrame': 'Evaluated at experimental day 0,1 and 6 of each intervention', 'description': 'Protein analysis of fat biopsies'}, {'measure': 'Blood pressure', 'timeFrame': 'The first 24 hours of intervention and at experimental day 6', 'description': 'Changes in blood pressure, mm Hg'}, {'measure': 'Pulse', 'timeFrame': 'The first 24 hours of intervention and at experimental day 6', 'description': 'Changes in pulse, beats per minute'}, {'measure': 'Glucose regulatory hormones', 'timeFrame': 'Evaluated at experimental day 0,1 and 6 of each intervention', 'description': 'Counter regulatory hormones: glucagon, noradrenalin, cortisol, somatotropin, and insulin/c-peptide. Incremental and total area under the Concentration-Time Curve'}, {'measure': 'Number of symptomatic hypoglycemic events', 'timeFrame': 'An average of 1 week', 'description': 'Self-reported events'}]}, 'oversightModule': {'isUsExport': False, 'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Gastric Inhibitory Polypeptide', 'Diabetes Mellitus, Type 1', 'Hypoglycemia', 'Glucose Metabolism Disorders', 'Metabolic Diseases', 'Endocrine System Diseases', 'Glucagon', 'Incretin'], 'conditions': ['Diabetes Mellitus, Type 1', 'Hypoglycemia']}, 'referencesModule': {'references': [{'pmid': '40004948', 'type': 'DERIVED', 'citation': 'Gilliam-Vigh H, Suppli MP, Heimburger SMN, Lund AB, Knop FK, Ellegaard AM. Cholesin mRNA Expression in Human Intestinal, Liver, and Adipose Tissues. Nutrients. 2025 Feb 8;17(4):619. doi: 10.3390/nu17040619.'}, {'pmid': '36111559', 'type': 'DERIVED', 'citation': 'Heimburger SMN, Hoe B, Nielsen CN, Bergman NC, Skov-Jeppesen K, Hartmann B, Holst JJ, Dela F, Overgaard J, Storling J, Vilsboll T, Dejgaard TF, Havelund JF, Gorshkov V, Kjeldsen F, Faergeman NJ, Madsen MR, Christensen MB, Knop FK. GIP Affects Hepatic Fat and Brown Adipose Tissue Thermogenesis but Not White Adipose Tissue Transcriptome in Type 1 Diabetes. J Clin Endocrinol Metab. 2022 Nov 25;107(12):3261-3274. doi: 10.1210/clinem/dgac542.'}, {'pmid': '34405256', 'type': 'DERIVED', 'citation': 'Heimburger SMN, Hoe B, Nielsen CN, Bergmann NC, Hartmann B, Holst JJ, Vilsboll T, Dejgaard TF, Christensen MB, Knop FK. The effect of 6-day subcutaneous glucose-dependent insulinotropic polypeptide infusion on time in glycaemic range in patients with type 1 diabetes: a randomised, double-blind, placebo-controlled crossover trial. Diabetologia. 2021 Nov;64(11):2425-2431. doi: 10.1007/s00125-021-05547-8. Epub 2021 Aug 17.'}]}, 'descriptionModule': {'briefSummary': 'In the present project the investigators will evaluate whether glucagonotropic properties of the gut-derived incretin hormone glucose-dependent insulinotropic polypeptide (GIP) may be utilized as a safeguard against hypoglycemia in the daily life of participants with type 1 Diabetes'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '75 Years', 'minimumAge': '18 Years', 'genderBased': True, 'genderDescription': 'Caucasian men', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Body mass index between 20 and 27 kg/m2\n* T1D (diagnosed according to the criteria of the World Health Organization) with HbA1c \\<69 mmol/mol (\\<8.5%)\n* Treatment with a stable insulin regimen ≥3 months\n* T1D duration between 2 and 15years\n* C-peptide negative (C-peptide ≤ 16 ng/ml)\n* Informed consent\n\nExclusion Criteria:\n\n* Anemia (hemoglobin outside normal range)\n* Known liver disease and/or ALAT and/or ASAT \\> 2 times normal values\n* Estimated glomerular filtration rate (eGFR) ≤60 ml/min/1.73 m2 or albuminuria\n* Prior Cardiovascular events and/or abnormal heart rate/blood pressure\n* Use of anti-diabetic medicine (other than insulin), corticosteroids or other drugs affecting glucose metabolism during the study period or within 30 days prior to randomization\n* Any physical or psychological condition that the investigator feels would interfere with trial participation'}, 'identificationModule': {'nctId': 'NCT03734718', 'briefTitle': 'The Role of Glucose-Dependent Insulinotropic Polypeptide in the Pathological Glucose Homeostasis Of Type 1 Diabetes', 'organization': {'class': 'OTHER', 'fullName': 'Steno Diabetes Center Copenhagen'}, 'officialTitle': 'The Role of Glucose-dependent Insulinotropic Polypeptide in the Pathological Glucose Homeostasis of Type 1 Diabetes', 'orgStudyIdInfo': {'id': 'GIPHOT'}, 'secondaryIdInfos': [{'id': 'H-18015379', 'type': 'OTHER', 'domain': 'Research Ethics in the Capital of Denmark'}]}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Glucose-Dependent Insulinotropic Polypeptide', 'description': '6-day continuous infusion of Glucose-Dependent Insulinotropic Polypeptide', 'interventionNames': ['Drug: GIP']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': 'Saline', 'interventionNames': ['Drug: GIP']}], 'interventions': [{'name': 'GIP', 'type': 'DRUG', 'description': 'Infusion of Glucose-dependent insulinotropic peptide', 'armGroupLabels': ['Glucose-Dependent Insulinotropic Polypeptide', 'Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2800', 'city': 'Hellerup', 'country': 'Denmark', 'facility': 'Steno Diabetes Center CopenhagenSteno Diabetes Center Copenhagen, Clinical Metabolic Physiology', 'geoPoint': {'lat': 55.73204, 'lon': 12.57093}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Steno Diabetes Center Copenhagen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}, 'annotationSection': {'annotationModule': {'unpostedAnnotation': {'unpostedEvents': [{'date': '2025-02-14', 'type': 'RELEASE'}, {'date': '2025-03-06', 'type': 'RESET'}], 'unpostedResponsibleParty': 'Steno Diabetes Center Copenhagen'}}}}