Ignite Creation Date:
2025-12-24 @ 6:28 PM
Ignite Modification Date:
2025-12-25 @ 3:58 PM
Study NCT ID:
NCT01048268
Status:
COMPLETED
Last Update Posted:
2015-07-14
First Post:
2010-01-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
Glucose-dependent Insulinotropic Polypeptide - New Role as Blood Glucose Stabilizer?
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D054795', 'term': 'Incretins'}], 'ancestors': [{'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}, {'id': 'D045505', 'term': 'Physiological Effects of Drugs'}, {'id': 'D020228', 'term': 'Pharmacologic Actions'}, {'id': 'D020164', 'term': 'Chemical Actions and Uses'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'QUADRUPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 30}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-07', 'completionDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-07-10', 'studyFirstSubmitDate': '2010-01-12', 'studyFirstSubmitQcDate': '2010-01-12', 'lastUpdatePostDateStruct': {'date': '2015-07-14', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-01-13', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2014-04', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'The difference in glucagon secretion quantified as the difference in plasma glucagon concentration and incremental baseline-subtracted area under the curve (AUC) for plasma glucagon', 'timeFrame': '-10, 0, 5, 10, 20, 30, 45, 60 and 90 minutes at each visit'}], 'secondaryOutcomes': [{'measure': 'The difference between the amount of infused glucose and the insulin responses', 'timeFrame': 'will be measured at each visit'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['T1DM', 'T2DM', 'GIP', 'Glucose-dependent insulinotropic polypeptide', 'Incretin'], 'conditions': ['Diabetes Mellitus']}, 'referencesModule': {'references': [{'pmid': '31665480', 'type': 'DERIVED', 'citation': 'Veedfald S, Vedtofte L, Skov-Jeppesen K, Deacon CF, Hartmann B, Vilsboll T, Knop FK, Christensen MB, Holst JJ. Glucose-Dependent Insulinotropic Polypeptide Is a Pancreatic Polypeptide Secretagogue in Humans. J Clin Endocrinol Metab. 2020 Mar 1;105(3):dgz097. doi: 10.1210/clinem/dgz097.'}]}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to determine whether glucose-dependent insulinotropic polypeptide (GIP) has a stabilizing function on the blood glucose', 'detailedDescription': "The aim of the study is to investigate the effect of GIP on the glucagon secretion during hyper-, eu- and hypoglycemia in healthy volunteers, patients with type 1 diabetes mellitus and patients with type 2 diabetes mellitus.\n\nFrom this, we will evaluate GIP's role as blood sugar stabilizer."}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Caucasians with T1DM (diagnosed according to WHO's criteria) without residual beta cell function (arginine test without increase in c-peptide) in treatment with long acting insulin OR\n* Caucasians with non-insulin treated T2DM (diagnosed according to WHO's criteria) OR\n* Caucasians without first degree relative with diabetes mellitus, with normal fasting plasma glucose and glucose tolerance along with negative islet and GAD-65 autoantibodies AND\n* Normal hemoglobin\n* Informed consent\n\nExclusion criteria:\n\n* Unwillingness to participate or the wish to leave the present study\n* HbA1c \\> 9 %\n* Liver disease (ALAT or ASAT \\> 2 times normal value)\n* Diabetic nephropathy (serum creatinin \\> 130 microM and/or albuminury)\n* Proliferative diabetic retinopathy (anamnetic)\n* Atherosclerotic heart disease or heart failure (NYHA group III and IV)\n* Anemia\n* Treatment with medicine which cannot be paused for 12 hours\n* Pregnancy and/or breast feeding\n* Fasting plasma glucose \\> 15 mM on the day of the experiment"}, 'identificationModule': {'nctId': 'NCT01048268', 'briefTitle': 'Glucose-dependent Insulinotropic Polypeptide - New Role as Blood Glucose Stabilizer?', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Gentofte, Copenhagen'}, 'officialTitle': 'Glucose-dependent Insulinotropic Polypeptide - New Role as Blood Glucose Stabilizer?', 'orgStudyIdInfo': {'id': 'GIP HYPO (MC)'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Healthy volunteers', 'interventionNames': ['Drug: glucose-dependent insulinotropic polypeptide', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Patients with Type 1 diabetes mellitus', 'interventionNames': ['Drug: glucose-dependent insulinotropic polypeptide', 'Drug: Placebo']}, {'type': 'EXPERIMENTAL', 'label': 'Patients with type 2 diabetes mellitus', 'interventionNames': ['Drug: glucose-dependent insulinotropic polypeptide', 'Drug: Placebo']}], 'interventions': [{'name': 'glucose-dependent insulinotropic polypeptide', 'type': 'DRUG', 'description': 'For the first 20 min of the experiment the volunteers will receive GIP at 4 pmol/kg body weight.\n\nFor the following 40 minutes the volunteers will receive 2 pmol/kg body weight', 'armGroupLabels': ['Healthy volunteers', 'Patients with Type 1 diabetes mellitus', 'Patients with type 2 diabetes mellitus']}, {'name': 'Placebo', 'type': 'DRUG', 'description': 'copy GIP infusion rates', 'armGroupLabels': ['Healthy volunteers', 'Patients with Type 1 diabetes mellitus', 'Patients with type 2 diabetes mellitus']}]}, 'contactsLocationsModule': {'locations': [{'zip': '2900', 'city': 'Hellerup', 'state': 'Copenhagen County', 'country': 'Denmark', 'facility': "Department of Internal Medicine F' laboratory", 'geoPoint': {'lat': 55.73204, 'lon': 12.57093}}], 'overallOfficials': [{'name': 'Mikkel Christensen, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Bispebjerg Hospital, Copenhagen'}, {'name': 'Filip K Knop, MD PhD', 'role': 'STUDY_DIRECTOR', 'affiliation': 'Diabetes Research Division, Department of Internal Medicine F, Gentofte Hospital, University of Copenhagen'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University Hospital, Gentofte, Copenhagen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'MD, PhD', 'investigatorFullName': 'Mikkel Christensen', 'investigatorAffiliation': 'University Hospital, Gentofte, Copenhagen'}}}}