Ignite Creation Date:
2025-12-24 @ 7:25 PM
Ignite Modification Date:
2025-12-29 @ 10:21 AM
Study NCT ID:
NCT04653103
Status:
UNKNOWN
Last Update Posted:
2021-05-18
First Post:
2020-11-20
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
NASH in Subjects With Different Classes of Obesity
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D065626', 'term': 'Non-alcoholic Fatty Liver Disease'}, {'id': 'D009765', 'term': 'Obesity'}, {'id': 'D009767', 'term': 'Obesity, Morbid'}], 'ancestors': [{'id': 'D005234', 'term': 'Fatty Liver'}, {'id': 'D008107', 'term': 'Liver Diseases'}, {'id': 'D004066', 'term': 'Digestive System Diseases'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Liver biopsy'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 500}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2020-11-20', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2021-05', 'completionDateStruct': {'date': '2023-01-25', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2021-05-17', 'studyFirstSubmitDate': '2020-11-20', 'studyFirstSubmitQcDate': '2020-11-26', 'lastUpdatePostDateStruct': {'date': '2021-05-18', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-12-04', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2021-01-25', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Prevalence of NASH', 'timeFrame': '6 months', 'description': 'Prevalence of NASH in a cohort of patients with different classes of obesity'}], 'secondaryOutcomes': [{'measure': 'Assessment of lipid profile', 'timeFrame': '6 months', 'description': 'Assessment of triglycerides, total cholesterol, LDL and HDL cholesterol'}, {'measure': 'Assessment of glycemic profile', 'timeFrame': '6 months', 'description': 'Assessment of fasting glucose'}, {'measure': 'Assessment of glycated hemoglobin', 'timeFrame': '6 months', 'description': 'Assessment of glycated hemoglobin'}, {'measure': 'Assessment of liver enzymes', 'timeFrame': '6 months', 'description': 'Assessment of AST, ALT, GGT'}, {'measure': 'Assessment of insulin', 'timeFrame': '6 months', 'description': 'Assessment of fasting insulin'}, {'measure': 'Assessment of metabolic profile', 'timeFrame': '6 months', 'description': 'Assessment of HOMA-IR index'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['NASH - Nonalcoholic Steatohepatitis', 'NAFLD', 'Obesity', 'Obesity, Morbid']}, 'descriptionModule': {'briefSummary': 'It is an observational trial on 500 subjects. The purpose of this trial is to assess the prevalence of non-alcoholic steatohepatitis (NASH) in subjects with different classes of obesity.', 'detailedDescription': 'Nonalcoholic fatty liver disease (NAFLD) is rapidly becoming the most common cause of chronic liver disease due to an increase in the prevalence of obesity. The development of NASH leads to an increase in morbidity and mortality. Since patients with obesity are at an increased risk of NASH, the aim of this trial is to assess the prevalence of NASH in this class of patients.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '69 Years', 'minimumAge': '19 Years', 'samplingMethod': 'NON_PROBABILITY_SAMPLE', 'studyPopulation': 'Patients with different classes of obesity', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Aged between 19 and 69 years\n\nExclusion Criteria:\n\n* Pregnancy\n* Active cancer\n* End stage renal failure\n* End stage liver failure\n* Being unable to understand and sign informed consent'}, 'identificationModule': {'nctId': 'NCT04653103', 'acronym': 'CONNECT', 'briefTitle': 'NASH in Subjects With Different Classes of Obesity', 'organization': {'class': 'OTHER', 'fullName': 'Catholic University of the Sacred Heart'}, 'officialTitle': 'Prevalence of NASH in Subjects With Different Classes of Obesity', 'orgStudyIdInfo': {'id': '20202011'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'Patients with obesity', 'description': 'Subjects with different classes of obesity', 'interventionNames': ['Procedure: Liver biopsy']}], 'interventions': [{'name': 'Liver biopsy', 'type': 'PROCEDURE', 'description': 'Biopsy of the liver to assess for Non-alcoholic steatohepatitis', 'armGroupLabels': ['Patients with obesity']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Roma', 'country': 'Italy', 'facility': 'University of Rome Sapienza', 'geoPoint': {'lat': 44.99364, 'lon': 11.10642}}, {'zip': '00168', 'city': 'Rome', 'country': 'Italy', 'facility': 'Catholic University School of Medicine', 'geoPoint': {'lat': 41.89193, 'lon': 12.51133}}], 'overallOfficials': [{'name': 'Geltrude Mingrone, MD, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Catholic University of the Sacred Heart'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Catholic University of the Sacred Heart', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Professor', 'investigatorFullName': 'Geltrude Mingrone', 'investigatorAffiliation': 'Catholic University of the Sacred Heart'}}}}