Ignite Creation Date:
2025-12-25 @ 2:36 AM
Ignite Modification Date:
2025-12-26 @ 1:12 AM
Study NCT ID:
NCT04442334
Status:
RECRUITING
Last Update Posted:
2023-01-06
First Post:
2020-05-12
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The European NAFLD Registry
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D065626', 'term': 'Non-alcoholic Fatty Liver Disease'}, {'id': 'D008103', 'term': 'Liver Cirrhosis'}, {'id': 'D005234', 'term': 'Fatty Liver'}, {'id': 'D006528', 'term': 'Carcinoma, Hepatocellular'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}, {'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D050171', 'term': 'Dyslipidemias'}, {'id': 'D006973', 'term': 'Hypertension'}, {'id': 'D009765', 'term': 'Obesity'}, {'id': 'D005355', 'term': 'Fibrosis'}], 'ancestors': [{'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D000230', 'term': 'Adenocarcinoma'}, {'id': 'D002277', 'term': 'Carcinoma'}, {'id': 'D009375', 'term': 'Neoplasms, Glandular and Epithelial'}, {'id': 'D009370', 'term': 'Neoplasms by Histologic Type'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D008113', 'term': 'Liver Neoplasms'}, {'id': 'D004067', 'term': 'Digestive System Neoplasms'}, {'id': 'D009371', 'term': 'Neoplasms by Site'}, {'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': 'D052439', 'term': 'Lipid Metabolism Disorders'}, {'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Blood (serum, plasma, whole blood, DNA, RNA), Liver tissue, Urine, stool, DNA, RNA'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 10000}, 'targetDuration': '10 Years', 'patientRegistry': True}, 'statusModule': {'overallStatus': 'RECRUITING', 'startDateStruct': {'date': '2015-05-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-01', 'completionDateStruct': {'date': '2030-12-31', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2023-01-05', 'studyFirstSubmitDate': '2020-05-12', 'studyFirstSubmitQcDate': '2020-06-19', 'lastUpdatePostDateStruct': {'date': '2023-01-06', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-06-22', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2030-12-31', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Detailed Characterisation of the NAFLD Patient Phenotype', 'timeFrame': '1 day', 'description': 'Prospective patient recruitment and collection of cross-sectional clinical data is undertaken (including clinical biochemistry/haematology, liver histology, comorbidities, prescribed medication and imaging data).These data will be used to determine number of participants exhibiting specific features of NAFLD/NASH disease severity at enrolment including: histological grade of disease and fibrosis stage (assessed using the well validated NASH Clinical Research Network "NAFLD Activity Score" \\[NAS\\] and the FLIP "Steatosis - Activity - Fibrosis" \\[SAF\\] systems), frequency of common metabolic comorbidities (eg type 2 diabetes mellitus, dyslipidaemia, cardiovascular disease), and associated changes in clinical biochemistry/haematology/imaging parameters. Biological samples to support clinical and translational research into disease pathophysiology (e.g. genetic, epigenetic, transcriptomic, metabolomic, proteomic and metagenomic datasets) and biomarker development/validation will be collected.'}], 'secondaryOutcomes': [{'measure': 'Disease Natural History', 'timeFrame': 'Through to study completion, an average of 5 years', 'description': 'Longitudinal follow-up of patients with NAFLD by annual review to characterise disease natural history and determine number of participants experiencing clinically significant events including the occurrence and timing of incident comorbidities and key target conditions of interest such as:\n\n* Death (cause of death)\n* Major Adverse Cardiovascular Events (MACE)\n* Hepatic (e.g. diagnosis of cirrhosis, hepatic decompensation, hepatocellular carcinoma, transplantation)\n* Other (diagnosis of extra-hepatic malignancy/emergency hospitalisation)\n\nRoutine clinical data generated as part of standard care will be collected annually. Clinical parameters assessed for changes indicative of alteration in disease state during follow-up include: clinical biochemistry/haematology, liver histology, comorbidities, prescribed medication and imaging data. Biological samples to support translational research into disease pathophysiology and biomarker development/validation will also be collected.'}, {'measure': 'Lifestyle factors: Dietary Habits', 'timeFrame': 'Through study completion, an average of 5 years', 'description': 'Cross-sectional and longitudinal study of dietary habits in patients with NAFLD using: Mediterranean Diet Score.'}, {'measure': 'Lifestyle factors: Activity/Exercise', 'timeFrame': 'Through study completion, an average of 5 years', 'description': 'Cross-sectional and longitudinal study of lifestyle factors (e.g. activity/sedentary behaviour/exercise levels) in patients with NAFLD using: International Physical Activity Questionnaire (IPAQ).'}, {'measure': 'Health Related Quality of Life: CLDQ', 'timeFrame': 'Through study completion, an average of 5 years', 'description': 'Cross-sectional and longitudinal collection of standardised data on HRQOL and symptom burden in patients with NAFLD using Patient Reported Outcome Measure (PROM): Chronic Liver Disease Questionnaire for NAFLD NASH (CLDQ NAFLD-NASH).'}, {'measure': 'Health Related Quality of Life: EQ5D5L', 'timeFrame': 'Through study completion, an average of 5 years', 'description': 'Cross-sectional and longitudinal collection of standardised data on HRQOL and symptom burden in patients with NAFLD using Patient Reported Outcome Measure (PROM): EQ-5D-5L Health'}, {'measure': 'Health Related Quality of Life: NASH-CHECK', 'timeFrame': 'Through study completion, an average of 5 years', 'description': 'Cross-sectional and longitudinal collection of standardised data on HRQOL and symptom burden in patients with NAFLD using Patient Reported Outcome Measure (PROM): NASH-CHECK.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['NAFLD', 'NASH', 'Steatohepatitis', 'Liver', 'Cirrhosis', 'Non-alcoholic fatty liver disease'], 'conditions': ['NAFLD', 'NASH', 'NASH - Nonalcoholic Steatohepatitis', 'Fibrosis, Liver', 'Steatosis of Liver', 'Hepatocellular Carcinoma', 'Cardiovascular Diseases', 'Type 2 Diabetes', 'Dyslipidaemia', 'Hypertension', 'Obesity', 'Other Associated Comorbidities']}, 'referencesModule': {'references': [{'pmid': '35434590', 'type': 'DERIVED', 'citation': 'McGlinchey AJ, Govaere O, Geng D, Ratziu V, Allison M, Bousier J, Petta S, de Oliviera C, Bugianesi E, Schattenberg JM, Daly AK, Hyotylainen T, Anstee QM, Oresic M. Metabolic signatures across the full spectrum of non-alcoholic fatty liver disease. JHEP Rep. 2022 Mar 26;4(5):100477. doi: 10.1016/j.jhepr.2022.100477. eCollection 2022 May.'}]}, 'descriptionModule': {'briefSummary': 'The European NAFLD Registry is a prospectively recruited, observational study supporting the study of the clinical phenotype, natural history, disease outcomes and pathophysiology of Non-Alcoholic Fatty Liver Disease and Non-Alcoholic Steatohepatitis. The ultimate goals are to better understand the drivers of interpatient variation in disease pathophysiology and severity and to utilise this information to develop and validate biomarkers that, singly or in combination, enable detection and monitoring of disease progression and/or from NAFL through NASH to fibrosis and cirrhosis.', 'detailedDescription': 'The European NAFLD Registry is a major international collaboration between clinical academics at leading universities across Europe, initially established with funding from the European Association for the Study of the Liver and through the EU FP7, H2020 and IMI2 schemes to the projects FLIP (Fatty Liver Inhibition of Progression), EPoS (Elucidating Pathways of Steatohepatitis) and LITMUS (Liver Investigation: Testing marker Utility in Steatohepatitis).\n\nThe Registry is a non-interventional, observational study collecting cross-sectional and longitudinal clinical data (including clinical biochemistry/haematology, liver histology, comorbidities, prescribed medication and imaging data) and linked biological samples (Blood \\[Serum, Plasma\\], Liver Tissue, Urine, Stool) from prospectively recruited patients with NAFLD. Its purpose is to support clinical and translational research into disease pathophysiology (through development of comprehensive genetic, epigenetic, transcriptomic, metabolomic, proteomic and metagenomic datasets) and biomarker development/validation. It supports collaborative discovery science and serves as the basis for a broad international project to discover and validate biomarkers for NAFLD and associated medical conditions (LITMUS). Out-with the current study, following separate ethical approval and after separate consent, patients who have agreed to join the European NAFLD Registry may also agree to participate in a number of nested sub-studies with bi-directional sharing of data. These include the LITMUS Imaging Study, which will acquire additional imaging data across a range of modalities including, amongst others, MR-PDFF and MR-Elastography. The Registry population comprises adult patients (aged ≥18 years) with risk factors for non-alcoholic fatty liver disease (NAFLD) prospectively recruited primarily in hepatology and diabetology clinics and/or bariatric surgery units at centres across Europe. After receiving informed consent, patients will be assigned a unique study identifier (which will be used to identify all data and samples collected) which will allow all information to be recorded in a link-anonymised form.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '100 Years', 'minimumAge': '18 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': "Adult patients with a pre-existing liver biopsy providing histological evidence of NAFLD or, patients undergoing liver biopsy for suspected NAFLD with biochemical and/or radiological findings consistent with NAFLD, or patients with radiological evidence of cirrhosis (in absence of an alternative aetiology) plus presence of ≥2 features indicative of the 'metabolic syndrome'.", 'healthyVolunteers': False, 'eligibilityCriteria': "Inclusion Criteria:\n\n1. Age ≥18 years.\n2. Clinically suspected NAFLD based on any of:\n\n 1. Patient with historical liver biopsy providing histological evidence of NAFLD or,\n 2. Patient undergoing liver biopsy for suspected NAFLD with biochemical and/or radiological findings consistent with NAFLD or,\n 3. Patient with radiological evidence of cirrhosis (in absence of an alternative aetiology) plus presence of ≥2 features indicative of the 'metabolic syndrome':\n\n * Increased waist circumference by ethnically adjusted criteria (e.g. Europid male/female ≥94cm/80cm) or overweight/obese (BMI ≥25);\n * Raised fasting glucose ≥100 mg/dL \\[5.6 mmol/L\\], HbA1c ≥48mmol/mol (6.5%) or previously diagnosed insulin resistance/type 2 diabetes mellitus (or on treatment);\n * Dyslipidaemia (fasting TG level ≥150 mg/dL \\[1.7 mmol/L\\]; or fasting HDL \\<40 mg/dL \\[1.03 mmol/L\\] in males and \\<50 mg/dL \\[1.29 mmol/L\\] in females; or on treatment);\n * Hypertension (systolic BP ≥130 or diastolic BP ≥85 mmHg, or on treatment).\n3. Average alcohol consumption less than 21/14 units/week (males/females) in preceding 6 months and no history of sustained excessive consumption of alcohol in past 5 years.\n\nExclusion Criteria\n\n1. Refusal or inability (lack of capacity) to give informed consent.\n2. Average alcohol ingestion greater than approximately 21/14 units/week (males/females) in preceding 6 months or history of sustained excessive consumption of alcohol in past 5 years.\n3. History or presence of Type 1 diabetes mellitus.\n4. Presence of any other form of chronic liver disease except NAFLD.\n5. Recent (within 12 months) or concomitant use of agents known to cause hepatic steatosis (long-term systemic corticosteroids \\[\\>10 days\\], amiodarone, methotrexate, tamoxifen, tetracycline, high dose oestrogens, valproic acid).\n6. Any contra-indication to liver biopsy.\n7. Recent (within 3 months) change in dose/regimen or introduction of Vitamin E (at a dose ≥400 IU/day), betaine, s-adenosyl methionine, ursodeoxycholic acid, silymarin or pentoxifylline.\n8. Non-English speaking/unable to access an interpreter. Due to the nature of the study, English language or access to a relevant interpreter is a necessary criterion to ensure lifestyle (diet and exercise) and symptom data are collated.\n9. Patients not meeting inclusion criteria or judged by the investigator to be unsuitable for inclusion in the study."}, 'identificationModule': {'nctId': 'NCT04442334', 'briefTitle': 'The European NAFLD Registry', 'organization': {'class': 'OTHER', 'fullName': 'Newcastle University'}, 'officialTitle': 'The European NAFLD Registry', 'orgStudyIdInfo': {'id': '08759'}, 'secondaryIdInfos': [{'id': '634413', 'type': 'OTHER_GRANT', 'domain': 'EU H2020'}, {'id': '777377', 'type': 'OTHER_GRANT', 'domain': 'EU H2020 IMI2'}]}, 'armsInterventionsModule': {'armGroups': [{'label': 'The LITMUS Study Cohort', 'description': 'Prospectively recruited NAFLD patients, recruited according to The European NAFLD Registry study protocol.'}, {'label': 'The LITMUS Metacohort', 'description': 'Collated data and biological samples on patients with histologically characterised NAFLD prospectively recruited at contributing academic centres across Europe.'}, {'label': 'EFPIA Clinical Trial Cohort', 'description': 'Collated data and biological samples on patients with histologically characterised NAFLD that have participated in phase 2 and phase 3 trials of IMPs for NAFLD.'}]}, 'contactsLocationsModule': {'locations': [{'city': 'Antwerp', 'status': 'RECRUITING', 'country': 'Belgium', 'contacts': [{'name': 'Sven M Francque, MD, PhD', 'role': 'CONTACT', 'email': 'Sven.Francque@uza.be', 'phone': '+3238214572'}, {'name': 'Sven M Francque, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Universitair Ziekenhuis Antwerpen', 'geoPoint': {'lat': 51.22047, 'lon': 4.40026}}, {'city': 'Helsinki', 'status': 'RECRUITING', 'country': 'Finland', 'contacts': [{'name': 'Hannele Yki-Järvinen, MD', 'role': 'CONTACT', 'email': 'Hannele.Yki-Jarvinen@helsinki.fi'}, {'name': 'Hannele Yki-Järvinen, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Helsinki University Hospital', 'geoPoint': {'lat': 60.16952, 'lon': 24.93545}}, {'zip': '49933', 'city': 'Angers', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Jerome Boursier, MD, PhD', 'role': 'CONTACT', 'email': 'JeBoursier@chu-angers.fr'}, {'name': 'Jerome Boursier, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Le Centre de Recherche Clinique (CRC) du CHU d'Angers", 'geoPoint': {'lat': 47.47156, 'lon': -0.55202}}, {'zip': '75013', 'city': 'Paris', 'status': 'RECRUITING', 'country': 'France', 'contacts': [{'name': 'Vlad Ratzu, MD', 'role': 'CONTACT', 'email': 'vlad.ratziu@inserm.fr'}, {'name': 'Vlad Ratzu, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Institut ICAN - Institute of Cardiometabolism And Nutrition Hôpital de la Pitié Salpêtrière', 'geoPoint': {'lat': 48.85341, 'lon': 2.3488}}, {'zip': '52074', 'city': 'Aachen', 'status': 'NOT_YET_RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Christian Trautwein, MD', 'role': 'CONTACT', 'email': 'ctrautwein@ukaachen.de'}, {'name': 'Christian Trautwein, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'UNIVERSITÄTSKLINIKUM der RWTH Aachen', 'geoPoint': {'lat': 50.77664, 'lon': 6.08342}}, {'city': 'Berlin', 'status': 'NOT_YET_RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Muenevver Demir, MD', 'role': 'CONTACT', 'email': 'muenevver.demir@charite.de'}, {'name': 'Muenevver Demir, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Charité University Hospital Berlin', 'geoPoint': {'lat': 52.52437, 'lon': 13.41053}}, {'zip': '79106', 'city': 'Freiburg im Breisgau', 'status': 'NOT_YET_RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Rafael Kaeser, DrMed', 'role': 'CONTACT', 'email': 'rafael.kaeser@uniklinik-freiburg-.de', 'phone': '+49 761 270-35500'}, {'name': 'Rafael Kaeser, DrMed', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Universitätsklinikum Freiburg', 'geoPoint': {'lat': 47.9959, 'lon': 7.85222}}, {'zip': '55131', 'city': 'Mainz', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Jörn M Schattenberg, DrMed', 'role': 'CONTACT', 'email': 'joern.schattenberg@unimedizin-mainz.de', 'phone': '+49 (0) 6131 176074'}, {'name': 'Jörn M Schattenberg, DrMed', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'UNIVERSITÄTSMEDIZIN der Johannes Gutenberg Universität Mainz', 'geoPoint': {'lat': 49.98185, 'lon': 8.28008}}, {'zip': 'D-97080', 'city': 'Würzburg', 'status': 'RECRUITING', 'country': 'Germany', 'contacts': [{'name': 'Andreas Geier, MD', 'role': 'CONTACT', 'email': 'Geier_A2@ukw.de'}, {'name': 'Andreas Geier, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Universitätsklinikums Würzburg', 'geoPoint': {'lat': 49.79391, 'lon': 9.95121}}, {'zip': '11527', 'city': 'Athens', 'status': 'RECRUITING', 'country': 'Greece', 'contacts': [{'name': 'Gergios Papatheodoridis, MD, PhD', 'role': 'CONTACT', 'email': 'gepapath@med.uoa.gr'}, {'name': 'Gergios Papatheodoridis, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Laiko General Hospital of Athens', 'geoPoint': {'lat': 37.98376, 'lon': 23.72784}}, {'city': 'Ancona', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Gianluca Svegliati-Baroni, MD', 'role': 'CONTACT', 'email': 'gsvegliati@gmail.com'}, {'name': 'Gianluca Svegliati-Baroni, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Polytechnic University of Marche', 'geoPoint': {'lat': 43.60717, 'lon': 13.5103}}, {'city': 'Milan', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Luca Valenti, MD', 'role': 'CONTACT', 'email': 'luca.valenti@unimi.it'}, {'name': 'Luca Valenti, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Università degli Studi Milano', 'geoPoint': {'lat': 45.46427, 'lon': 9.18951}}, {'city': 'Palermo', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Salvatore Petta, MD, PhD', 'role': 'CONTACT', 'email': 'petta.salvatore@unipa.it'}, {'name': 'Salvatore Petta, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Università di Palermo', 'geoPoint': {'lat': 38.1166, 'lon': 13.3636}}, {'city': 'Rome', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Luca Miele, MD, PhD', 'role': 'CONTACT', 'email': 'luca.miele@policlinicogemelli.it'}, {'name': 'Luca Miele, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Università Cattolica del Sacro Cuore', 'geoPoint': {'lat': 41.89193, 'lon': 12.51133}}, {'city': 'Turin', 'status': 'RECRUITING', 'country': 'Italy', 'contacts': [{'name': 'Elisabetta Bugianesi, MD, PhD', 'role': 'CONTACT', 'email': 'elisabetta.bugianesi@unito.it'}, {'name': 'Elisabetta Bugianesi, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Department of Medical Sciences University of Torino', 'geoPoint': {'lat': 45.07049, 'lon': 7.68682}}, {'city': 'Amsterdam', 'status': 'RECRUITING', 'country': 'Netherlands', 'contacts': [{'name': 'A G Holleboom, MD, PhD', 'role': 'CONTACT', 'email': 'a.g.holleboom@amsterdamumc.nl'}, {'name': 'A G Holleboom, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Ulrich Beuers, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Amsterdam UMC', 'geoPoint': {'lat': 52.37403, 'lon': 4.88969}}, {'city': 'Lisbon', 'status': 'RECRUITING', 'country': 'Portugal', 'contacts': [{'name': 'Helena Cortez-Pinto, MD, PhD', 'role': 'CONTACT', 'email': 'hlcortezpinto@netcabo.pt'}, {'name': 'Helena Cortez-Pinto, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hospital de Santa Maria', 'geoPoint': {'lat': 38.72509, 'lon': -9.1498}}, {'city': 'Barcelona', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Salva Augustin, MD', 'role': 'CONTACT', 'email': 'salva.augustin@gmail.com'}, {'name': 'Salva Augustin, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Vall d'Hebron University Hospital", 'geoPoint': {'lat': 41.38879, 'lon': 2.15899}}, {'city': 'Donostia / San Sebastian', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Jesus Banales, PhD', 'role': 'CONTACT', 'email': 'Jesus.banales@biodonostia.org'}, {'name': 'Jesus Banales, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Biodonostia Health Research Institute', 'geoPoint': {'lat': 43.31283, 'lon': -1.97499}}, {'city': 'Majadahonda', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Joseluis Calleja, MD', 'role': 'CONTACT', 'email': 'Joseluis.calleja@uam.es'}, {'name': 'Joseluis Calleja, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Puerta de Hierro University Hospital', 'geoPoint': {'lat': 40.47353, 'lon': -3.87182}}, {'city': 'Santander', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Javier Crespo, MD', 'role': 'CONTACT', 'email': 'Javiercrespo1991@gmail.com'}, {'name': 'Javier Crespo, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Marqués de Valdecilla University Hospital', 'geoPoint': {'lat': 43.46589, 'lon': -3.80493}}, {'city': 'Seville', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Manuel Romero-Gomez, MD', 'role': 'CONTACT', 'email': 'mromerogomez@us.es'}, {'name': 'Manuel Romero-Gomez, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Institute of Biomedicine of Sevilla (IBiS), Virgen del Rocío University Hospital', 'geoPoint': {'lat': 37.38283, 'lon': -5.97317}}, {'city': 'Valladolid', 'status': 'RECRUITING', 'country': 'Spain', 'contacts': [{'name': 'Rocío Aller de la Fuente, MD, PhD', 'role': 'CONTACT', 'email': 'rallerf@saludcastillayleon.es'}, {'name': 'Rocío Aller de la Fuente, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'HU Clínico de Valladolid', 'geoPoint': {'lat': 41.65541, 'lon': -4.72353}}, {'city': 'Huddinge', 'status': 'RECRUITING', 'country': 'Sweden', 'contacts': [{'name': 'Hannes Hagstrom, MD', 'role': 'CONTACT', 'email': 'hannes.hagstrom@ki.se'}, {'name': 'Hannes Hagstrom, MD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Karolinska Universitetssjukhuset', 'geoPoint': {'lat': 59.23705, 'lon': 17.98192}}, {'city': 'Linköping', 'status': 'RECRUITING', 'country': 'Sweden', 'contacts': [{'name': 'Mattias Ekstedt, MD', 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'country': 'United Kingdom', 'contacts': [{'name': 'Michael Allison, MBBS, PhD', 'role': 'CONTACT', 'email': 'michael.allison@addenbrookes.nhs.uk'}, {'name': 'Mike Allison, MBBS, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': "Addenbrooke'S Hospital", 'geoPoint': {'lat': 52.2, 'lon': 0.11667}}, {'city': 'Gateshead', 'status': 'NOT_YET_RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Dina Mansour, MA, MBBS', 'role': 'CONTACT', 'email': 'dina.mansour@nhs.net'}, {'name': 'Dina Mansour, MA, MBBS', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Queen Elizabeth Hospital', 'geoPoint': {'lat': 54.96209, 'lon': -1.60168}}, {'city': 'Hull', 'status': 'RECRUITING', 'country': 'United Kingdom', 'contacts': [{'name': 'Lynsey Corless, MBChB, PhD', 'role': 'CONTACT', 'email': 'lynsey.corless@hey.nhs.uk'}, {'name': 'Lynsey Corless, MBChB, PhD', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Hull Royal Infirmary', 'geoPoint': {'lat': 53.7446, 'lon': -0.33525}}, {'city': 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