Ignite Creation Date:
2025-12-25 @ 3:54 AM
Ignite Modification Date:
2026-02-26 @ 3:15 AM
Study NCT ID:
NCT03824002
Status:
COMPLETED
Last Update Posted:
2019-01-31
First Post:
2018-12-06
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Dulaglutide in Diabetic Patients, Relationship Between Arterial Stiffness, Endothelial Function, Clinical and Laboratory Variables
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': 'C555680', 'term': 'dulaglutide'}, {'id': 'D061267', 'term': 'Insulin Aspart'}, {'id': 'D000069036', 'term': 'Insulin Glargine'}, {'id': 'D008687', 'term': 'Metformin'}, {'id': 'C072379', 'term': 'repaglinide'}], 'ancestors': [{'id': 'D061266', 'term': 'Insulin, Short-Acting'}, {'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': 'D049528', 'term': 'Insulin, Long-Acting'}, {'id': 'D001645', 'term': 'Biguanides'}, {'id': 'D006146', 'term': 'Guanidines'}, {'id': 'D000578', 'term': 'Amidines'}, {'id': 'D009930', 'term': 'Organic Chemicals'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE4'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'CARE_PROVIDER']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 92}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2017-04-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2019-01', 'completionDateStruct': {'date': '2018-04-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2019-01-29', 'studyFirstSubmitDate': '2018-12-06', 'studyFirstSubmitQcDate': '2019-01-29', 'lastUpdatePostDateStruct': {'date': '2019-01-31', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2019-01-31', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-10-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change from Baseline Reactive Hyperemia Index at 3 and 9 months', 'timeFrame': '0 months, 3 months and 9 months', 'description': 'Endothelial function index RHI'}], 'secondaryOutcomes': [{'measure': 'Change from Baseline systolic blood pressure at 3 and 9 months', 'timeFrame': '0 months, 3 months and 9 months', 'description': 'systolic blood pressure in mmHg'}, {'measure': 'Change from Baseline Body Mass Index at 3 and 9 months', 'timeFrame': '0 months, 3 months and 9 months', 'description': 'weight and height will be combined to report BMI in kg/m\\^2'}, {'measure': 'Change from Baseline cholesterol at 3 and 9 months', 'timeFrame': '0 months, 3 months and 9 months', 'description': 'blood cholesterol in mg/dl'}, {'measure': 'Change from Baseline triglycerides at 3 and 9 months', 'timeFrame': '0 months, 3 months and 9 months', 'description': 'blood triglycerides in mg/dl'}, {'measure': 'Change from Baseline glucose at 3 and 9 months', 'timeFrame': '0 months, 3 months and 9 months', 'description': 'fasting blood glucose in mg/dl'}, {'measure': 'Change from Baseline diastolic blood pressure at 3 and 9 months', 'timeFrame': '0 months, 3 months and 9 months', 'description': 'diastolic blood pressure in mmHg'}, {'measure': 'Change from Baseline Pulse Wave Velocity at 3 and 9 months', 'timeFrame': '0 months, 3 months and 9 months', 'description': 'Pulse Wave Velocity in m/s'}]}, 'oversightModule': {'isUsExport': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['diabetes mellitus', 'dulaglutide', 'endothelial function'], 'conditions': ['Diabetes Mellitus']}, 'referencesModule': {'references': [{'pmid': '39963952', 'type': 'DERIVED', 'citation': 'Natale P, Green SC, Tunnicliffe DJ, Pellegrino G, Toyama T, Strippoli GF. Glucagon-like peptide 1 (GLP-1) receptor agonists for people with chronic kidney disease and diabetes. Cochrane Database Syst Rev. 2025 Feb 18;2(2):CD015849. doi: 10.1002/14651858.CD015849.pub2.'}]}, 'descriptionModule': {'briefSummary': 'The study aims to evaluate arterial stiffness and endothelial function indexes and their relationship with clinic and laboratory varible in a group of diabetic patients in treatment with dulaglutide', 'detailedDescription': '46 patients with type 2 diabetes mellitus were recruited at the Internal Medicine with Stroke care ward of the University hospital of Palermo "P. Giaccone" from April 2017 to April 2018. For all patients treatment with dulaglutide was undertaken. As control group were recruited 46 patients from the same ward not affected by diabetes mellitus or affected by diabetes mellitus but not in treatment with dulaglutide.\n\nThe study was carried out in accordance with the principles of the Helsinki Declaration revised in 2001 and all patients gave their written consent to take part in this research.\n\nEach patient treated with dulaglutide was compared for age, sex and cardiovascular risk with control patients. The diagnosis of type 2 diabetes mellitus was based on the revised criteria of the American Diabetes Association (ADA), and using a clinical algorithm that considered the age of onset of the disease, the symptoms and weight present, the family history and the therapy practiced. Arterial hypertension was defined according to the 2017 ESC-ESH criteria. Dyslipidemia was defined based on total cholesterol levels\\> 200 mg/dl, triglycerides\\> 150 mg/dl and HDL levels \\<40 mg/dl regardless of the patient\'s gender.\n\nAmong the cases enrolled, 46 (100%) had type 2 diabetes mellitus, 37 (80.43%) had arterial hypertension and 26 (56.52%) hypercholesterolemia.\n\nClinical and anthropometric data were collected at the time of recruitment. Blood samples were taken from each patient (cases and controls) to determine serum glucose, HbA1c, total cholesterol, HDL and LDL cholesterol, triglycerides, creatinine, and a urine sample to assess the presence of microalbuminuria. These withdrawals were then repeated three months and nine months from the time of recruitment.\n\nThe digital endothelial function was evaluated through the RHI-pat analysis using Endo-PAT2000. Pulse Wave Velocity (PWV) Carotid-Femoral Pulse was measured in the supine position using an automatic device (SphygmoCor version 7.1) that evaluated the propagation time of the sphygmic wave between the carotid and femoral pulse.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '90 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* diabetes mellitus\n\nExclusion Criteria:\n\n* cancer, severe ckd, end stage liver disease'}, 'identificationModule': {'nctId': 'NCT03824002', 'briefTitle': 'Dulaglutide in Diabetic Patients, Relationship Between Arterial Stiffness, Endothelial Function, Clinical and Laboratory Variables', 'organization': {'class': 'OTHER', 'fullName': 'University of Palermo'}, 'officialTitle': 'Arterial Stiffness and Endothelial Function Indexes, Relationships With Clinical and Laboratory Variables in a Group of Diabetic Patients in Treatment With Dulaglutide: a Case-control Study', 'orgStudyIdInfo': {'id': '21772'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'patients treated with dulaglutide', 'description': 'Diabetes therapy with dulaglutide and various combinations of aspart insulin, glargine, metformin, repaglinide', 'interventionNames': ['Drug: Dulaglutide', 'Drug: Aspart insulin', 'Drug: Glargine', 'Drug: Metformin', 'Drug: Repaglinide']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'patients not treated with dulaglutide', 'description': 'Diabetes therapy with various combinations of aspart insulin, glargine, metformin, repaglinide but without dulaglutide', 'interventionNames': ['Drug: Aspart insulin', 'Drug: Glargine', 'Drug: Metformin', 'Drug: Repaglinide']}], 'interventions': [{'name': 'Dulaglutide', 'type': 'DRUG', 'otherNames': ['aspart insulin', 'glargine insulin', 'metformin', 'repaglinide'], 'description': 'Diabetes therapy with dulaglutide and various combinations of insulin, metformin, glinides', 'armGroupLabels': ['patients treated with dulaglutide']}, {'name': 'Aspart insulin', 'type': 'DRUG', 'description': 'Diabetes therapy with various combinations of insulin, metformin, glinides but without dulaglutide', 'armGroupLabels': ['patients not treated with dulaglutide', 'patients treated with dulaglutide']}, {'name': 'Glargine', 'type': 'DRUG', 'description': 'Diabetes therapy with various combinations of insulin, metformin, glinides but without dulaglutide', 'armGroupLabels': ['patients not treated with dulaglutide', 'patients treated with dulaglutide']}, {'name': 'Metformin', 'type': 'DRUG', 'description': 'Diabetes therapy with various combinations of insulin, metformin, glinides but without dulaglutide', 'armGroupLabels': ['patients not treated with dulaglutide', 'patients treated with dulaglutide']}, {'name': 'Repaglinide', 'type': 'DRUG', 'description': 'Diabetes therapy with various combinations of insulin, metformin, glinides but without dulaglutide', 'armGroupLabels': ['patients not treated with dulaglutide', 'patients treated with dulaglutide']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90127', 'city': 'Palermo', 'country': 'Italy', 'facility': 'Internal Medicine Ward, University of Palermo', 'geoPoint': {'lat': 38.1166, 'lon': 13.3636}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Palermo', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'University professor', 'investigatorFullName': 'Antonino Tuttolomondo', 'investigatorAffiliation': 'University of Palermo'}}}}