Ignite Creation Date:
2025-12-24 @ 7:08 PM
Ignite Modification Date:
2026-01-02 @ 3:15 PM
Study NCT ID:
NCT03195257
Status:
COMPLETED
Last Update Posted:
2017-06-23
First Post:
2017-06-19
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Glucose-Dependent Insulinotropic Polypeptide - Effects on Markers of Bone Turnover 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': 'D054795', 'term': 'Incretins'}, {'id': 'D052216', 'term': 'Glucagon-Like Peptide 1'}, {'id': 'D012965', 'term': 'Sodium Chloride'}], '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'}, {'id': 'D004763', 'term': 'Glucagon-Like Peptides'}, {'id': 'D052336', 'term': 'Proglucagon'}, {'id': 'D005768', 'term': 'Gastrointestinal Hormones'}, {'id': 'D002712', 'term': 'Chlorides'}, {'id': 'D006851', 'term': 'Hydrochloric Acid'}, {'id': 'D017606', 'term': 'Chlorine Compounds'}, {'id': 'D007287', 'term': 'Inorganic Chemicals'}, {'id': 'D017670', 'term': 'Sodium Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER', 'INVESTIGATOR'], 'maskingDescription': 'Randomized, double-blinded, cross-over study with 5 study days.'}, 'primaryPurpose': 'BASIC_SCIENCE', 'interventionModel': 'CROSSOVER'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 10}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-11-17', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2017-06', 'completionDateStruct': {'date': '2016-12-01', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2017-06-21', 'studyFirstSubmitDate': '2017-06-19', 'studyFirstSubmitQcDate': '2017-06-20', 'lastUpdatePostDateStruct': {'date': '2017-06-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2017-06-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2016-12-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'C-terminal telopeptide of type I collagen (CTX).', 'timeFrame': '30 minutes intervals, time 0 up to 120 min'}], 'secondaryOutcomes': [{'measure': 'Parathyroid hormone (PTH)', 'timeFrame': '30 minutes intervals, time 0 up to 120 min'}, {'measure': 'N-terminal propeptide of type 1 procollagen (P1NP).', 'timeFrame': '30 minutes intervals, time 0 up to 120 min'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Type 1 Diabetes Mellitus']}, 'referencesModule': {'references': [{'pmid': '29099978', 'type': 'DERIVED', 'citation': 'Christensen MB, Lund A, Calanna S, Jorgensen NR, Holst JJ, Vilsboll T, Knop FK. Glucose-Dependent Insulinotropic Polypeptide (GIP) Inhibits Bone Resorption Independently of Insulin and Glycemia. J Clin Endocrinol Metab. 2018 Jan 1;103(1):288-294. doi: 10.1210/jc.2017-01949.'}]}, 'descriptionModule': {'briefSummary': 'Investigate GIP effects on biomarkers involved in bone homeostasis'}, 'eligibilityModule': {'sex': 'MALE', 'stdAges': ['ADULT'], 'maximumAge': '50 Years', 'minimumAge': '18 Years', 'genderBased': True, 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Patients with type 1 diabetes (positive islet cell/ glutamic acid decarboxylase-65 antibodies)\n* Patients without measurable beta cell function (i.e. incremental C-peptide below detection limit (\\<0.16 nmol/l) following an 5 g-iv-arginine stimulation test,\n\nExclusion Criteria:\n\n* HbA1c \\>9% (75 mmol/mol),\n* standard plasma biochemical measurements outside normal reference interval (alanine aminotransferase, bilirubin, thyroid-stimulating hormone, hemoglobin, creatinine, and spot urine albumin-creatinine ratio);\n* an abnormal state of hypoglycemia awareness,\n* significant diabetic complications (i.e. proliferative diabetic retinopathy, neuropathy, severe atherosclerosis, heart disease) and,\n* treatment with medication (besides insulin) that could not be paused for 12 hours up to and during the days of the experiments.'}, 'identificationModule': {'nctId': 'NCT03195257', 'briefTitle': 'Glucose-Dependent Insulinotropic Polypeptide - Effects on Markers of Bone Turnover in Patients With Type 1 Diabetes', 'organization': {'class': 'OTHER', 'fullName': 'University Hospital, Gentofte, Copenhagen'}, 'officialTitle': 'Glucose-Dependent Insulinotropic Polypeptide - Effects on Markers of Bone Turnover in Patients With Type 1 Diabetes', 'orgStudyIdInfo': {'id': 'GIP-T1DM-BTM'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Hypoglycemia-saline', 'interventionNames': ['Other: Saline']}, {'type': 'EXPERIMENTAL', 'label': 'Hypoglycemia-GIP', 'interventionNames': ['Other: GIP']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Hypoglycemia-GLP-1', 'interventionNames': ['Other: GLP-1']}, {'type': 'EXPERIMENTAL', 'label': 'Hyperglycemia-GIP', 'interventionNames': ['Other: GIP']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Hyperglycemia-Saline', 'interventionNames': ['Other: Saline']}], 'interventions': [{'name': 'GIP', 'type': 'OTHER', 'otherNames': ['Glucose-Dependent Insulinotropic Polypeptide'], 'description': "On 3 matched days with 'hypoglycemia' (i.e. plasma glucose clamped between 3-7 mol/L for 120 minutes) either GIP (4 pmol/kg/min), glucagon-like-peptide-1 (GLP-1) (1 pmol/kg/min) or placebo (saline) was administered; and on 2 separately matched days with 'hyperglycemia' (i.e. clamped at 12 mmol/L for 90 minutes) either GIP (4 pmol/kg/min) or saline was administered.", 'armGroupLabels': ['Hyperglycemia-GIP', 'Hypoglycemia-GIP']}, {'name': 'GLP-1', 'type': 'OTHER', 'otherNames': ['glucagon-like-peptide-1'], 'description': "On 3 matched days with 'hypoglycemia' (i.e. plasma glucose clamped between 3-7 mol/L for 120 minutes) either GIP (4 pmol/kg/min), glucagon-like-peptide-1 (GLP-1) (1 pmol/kg/min) or placebo (saline) was administered; and on 2 separately matched days with 'hyperglycemia' (i.e. clamped at 12 mmol/L for 90 minutes) either GIP (4 pmol/kg/min) or saline was administered.", 'armGroupLabels': ['Hypoglycemia-GLP-1']}, {'name': 'Saline', 'type': 'OTHER', 'otherNames': ['placebo'], 'description': "On 3 matched days with 'hypoglycemia' (i.e. plasma glucose clamped between 3-7 mol/L for 120 minutes) either GIP (4 pmol/kg/min), glucagon-like-peptide-1 (GLP-1) (1 pmol/kg/min) or placebo (saline) was administered; and on 2 separately matched days with 'hyperglycemia' (i.e. clamped at 12 mmol/L for 90 minutes) either GIP (4 pmol/kg/min) or saline was administered.", 'armGroupLabels': ['Hyperglycemia-Saline', 'Hypoglycemia-saline']}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Mikkel Christensen', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'Associate Professor, Principal Investigator', 'investigatorFullName': 'Mikkel Christensen', 'investigatorAffiliation': 'University Hospital, Gentofte, Copenhagen'}}}}