Ignite Creation Date:
2025-12-24 @ 5:08 PM
Ignite Modification Date:
2026-01-29 @ 2:18 PM
Study NCT ID:
NCT02501850
Status:
UNKNOWN
Last Update Posted:
2015-07-21
First Post:
2015-07-16
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
The Effect of the GLP-1 Receptor Agonists on Blood Levels of Lipoprotein (a)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], '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'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D000069450', 'term': 'Liraglutide'}, {'id': 'D000077270', 'term': 'Exenatide'}, {'id': 'C479460', 'term': 'lixisenatide'}, {'id': 'D008687', 'term': 'Metformin'}], 'ancestors': [{'id': 'D052216', 'term': 'Glucagon-Like Peptide 1'}, {'id': 'D004763', 'term': 'Glucagon-Like Peptides'}, {'id': 'D052336', 'term': 'Proglucagon'}, {'id': 'D005768', 'term': 'Gastrointestinal 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': 'D014688', 'term': 'Venoms'}, {'id': 'D045424', 'term': 'Complex Mixtures'}, {'id': 'D014118', 'term': 'Toxins, Biological'}, {'id': 'D001685', 'term': 'Biological Factors'}, {'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': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2014-10'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-07', 'completionDateStruct': {'date': '2015-10', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-07-20', 'studyFirstSubmitDate': '2015-07-16', 'studyFirstSubmitQcDate': '2015-07-16', 'lastUpdatePostDateStruct': {'date': '2015-07-21', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-07-17', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-07', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Change in blood levels of Lipoprotein (a) (Lp(a))', 'timeFrame': 'Baseline and two months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Lipoprotein (a)'], 'conditions': ['Diabetes Mellitus Type 2']}, 'referencesModule': {'references': [{'pmid': '15793200', 'type': 'BACKGROUND', 'citation': 'Hernandez C, Francisco G, Chacon P, Simo R. Lipoprotein(a) as a risk factor for cardiovascular mortality in type 2 diabetic patients: a 10-year follow-up study. Diabetes Care. 2005 Apr;28(4):931-3. doi: 10.2337/diacare.28.4.931. No abstract available.'}, {'pmid': '12964817', 'type': 'BACKGROUND', 'citation': 'Hernandez C, Francisco G, Chacon P, Mesa J, Simo R. Biological variation of lipoprotein(a) in a diabetic population. Analysis of the causes and clinical implications. Clin Chem Lab Med. 2003 Aug;41(8):1075-80. doi: 10.1515/CCLM.2003.166.'}, {'pmid': '21500721', 'type': 'BACKGROUND', 'citation': 'Genser B, Dias KC, Siekmeier R, Stojakovic T, Grammer T, Maerz W. Lipoprotein (a) and risk of cardiovascular disease--a systematic review and meta analysis of prospective studies. Clin Lab. 2011;57(3-4):143-56.'}]}, 'descriptionModule': {'briefSummary': 'Lipoprotein (a) \\[Lp (a)\\] is an independent cardiovascular risk (CVR) both in the general population and in patients with type 2 diabetes mellitus (DM-2). Until now no effective treatment is known to decrease the levels of Lp (a) levels and thus achieve a reduction of CVR. Among the new antidiabetic drugs are GLP-1Receptor agonists(GLP-1R). In addition to lowering blood glucose, these drugs have other beneficial effects. In our laboratory we have demonstrated that both native GLP-1 and various GLP-1R agonsits reduce the synthesis of Lp (a) in hepatocytes. The objective of the study is to test in humans the results observed in vitro. We will analyze whether treatment with GLP-1R agonists (Liraglutide, Exenatide or Lixisenatida) will reduce serum levels of Lp (a) in patients with DM-2.', 'detailedDescription': "Background: Lipoprotein (a) \\[Lp (a)\\] is an independent cardiovascular risk (CVR) both in the general population and in patients with type 2 diabetes mellitus (DM-2). Until now no effective treatment is known to decrease the levels of Lp (a) levels and thus achieve a reduction of CVR. Among the new antidiabetic drugs are GLP-1Receptor agonists(GLP-1R). In addition to lowering blood glucose, these drugs have other beneficial effects. In our laboratory we have demonstrated that both native GLP-1 and various GLP-1R agonsits reduce the synthesis of Lp (a) in hepatocytes.\n\nHypothesis: Treatment with GLP-1R agonists will lower the levels of Lp (a) in patients with DM-2.\n\nObjective: The objective of the study is to confirm in humans the results observed in vitro. We will analyze whether treatment with GLP-1R agonists (Liraglutide, Exenatide or Lixisenatida) will reduce serum levels of Lp (a) in patients with DM-2.\n\nMethods: we will evaluate 40 patients with DM-2 treated at the Endocrinology Department of the Vall d'Hebron University Hospital. The patients will be distributed in two groups according to the treatment prescribed by the endocrinologist during the visit of routine monitoring: group A (20 patients who were prescribred treatment with GLP-1R agonists) and group B (20 patients who were not prescribed this treatment). According to the current guidelines for treating DM-2, the GLP-1R agonists are situated as a second line treatment after metformin, and the treatment should be individualized according to the characteristics of each patient. (Inzucchi et al. Management of hyperglycemia in type 2 diabetes: a patient-centered approach: position statement of the American Diabetes Association (ADA) and the European Association for the Study of Diabetes (EASD) Diabetes Care 2012; 35 (6):.. 1364-1379). Following these recommendations, the GLP-1R agonists are usually selected when there is obesity and / or very important to avoid hypoglycaemia. The decision to prescribe a GLP-1R agonist is made by the endocrinologist before and independently of the patient´s participation in the study.\n\nBlood levels of Lp(a) will be evaluated at baseline and at 2 months (+/- 15 days). Diabetic patients who are treated with insulin, enzyme inhibitors DPP-4 (IDDP-4) or already treated with receptor agonists GLP-1, presenting with kidney and liver failure, HbA1c\\> 10%, LDL-cholesterol\\> 180 mg / dl and / or triglycerides\\> 350 mg / dl will excluded.\n\nRelevance: The results will identify a potential treatment for lowering levels of Lp (a) in patients with DM-2 and thus reducing cardiovascular risk associated with this lipoprotein."}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '50 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Type 2 diabetes\n* age between 50-65 years\n* written informed consent\n\nExclusion Criteria:\n\n* active GLP-1R agonist, insulin or DPP-IV treatment.\n* Liver failure (3lsn AST and/or ALT)\n* Kidney failure (FG \\<30ml/min/1,73m2),\n* HbA1c\\> 10%\n* LDL-cholesterol\\> 180 mg/dl\n* Triglycerides\\> 350 mg/dl'}, 'identificationModule': {'nctId': 'NCT02501850', 'acronym': 'EGLIPA', 'briefTitle': 'The Effect of the GLP-1 Receptor Agonists on Blood Levels of Lipoprotein (a)', 'organization': {'class': 'OTHER', 'fullName': "Hospital Universitari Vall d'Hebron Research Institute"}, 'officialTitle': 'The Effect of the GLP-1 Receptor Agonists on Blood Levels of Lipoprotein (a)', 'orgStudyIdInfo': {'id': 'VHI-GLP-2014-01'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Group A', 'description': 'Type 2 diabetic patients whom were prescribed GLP-1R agonists by the endocrinologist, according to usual clinical practice (liraglutide, exenatide, lixisenatide). The intervention is the prescription of an GLP-1R agonist (liraglutide, exenatide, lixisenatide)', 'interventionNames': ['Drug: Liraglutide']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Group B', 'description': 'Type 2 diabetic patients whom were prescribed metformin and/or sulphonilurea, according to usual clinical practice.', 'interventionNames': ['Drug: metformin']}], 'interventions': [{'name': 'Liraglutide', 'type': 'DRUG', 'otherNames': ['Exenatide', 'Lixisenatide'], 'description': 'Treatment with liraglutide, exenatide or lixisenatide', 'armGroupLabels': ['Group A']}, {'name': 'metformin', 'type': 'DRUG', 'otherNames': ['sulphonilurea'], 'description': 'Treatment with metformin and/or sulphonilurea', 'armGroupLabels': ['Group B']}]}, 'contactsLocationsModule': {'locations': [{'zip': '08035', 'city': 'Barcelona', 'state': 'Barcelona', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Andreea Ciudin, PhD', 'role': 'CONTACT', 'email': 'aciudin@vhebron.net', 'phone': '+34932744736'}, {'name': 'Cristina Hernandez, MD, PhD', 'role': 'CONTACT', 'email': 'cristina.hernandez@vhir.org', 'phone': '+34 932746591'}, {'name': 'Cristina Hernandez, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Andreea Ciudin, MD', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Olga Simó-Servat, MD', 'role': 'SUB_INVESTIGATOR'}], 'facility': "Hospital Universitari Vall d'Hebron", 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}], 'centralContacts': [{'name': 'Cristina Hernandez, MD, PhD', 'role': 'CONTACT', 'email': 'cristina.hernandez@vhir.org', 'phone': '+34 934894172', 'phoneExt': '4172'}, {'name': 'Andreea Ciudin, PhD', 'role': 'CONTACT', 'email': 'aciudin@vhebron.net', 'phone': '+34 932744736', 'phoneExt': '4736'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "Hospital Universitari Vall d'Hebron Research Institute", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}