Ignite Creation Date:
2025-12-25 @ 1:34 AM
Ignite Modification Date:
2025-12-25 @ 11:48 PM
Study NCT ID:
NCT04524494
Status:
COMPLETED
Last Update Posted:
2020-08-24
First Post:
2020-08-19
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Human Intestinal Amino Acid Absorption and the Role of a Local RAS
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'interventionBrowseModule': {'meshes': [{'id': 'D001800', 'term': 'Blood Specimen Collection'}, {'id': 'D059349', 'term': 'Urine Specimen Collection'}], 'ancestors': [{'id': 'D013048', 'term': 'Specimen Handling'}, {'id': 'D019411', 'term': 'Clinical Laboratory Techniques'}, {'id': 'D019937', 'term': 'Diagnostic Techniques and Procedures'}, {'id': 'D003933', 'term': 'Diagnosis'}, {'id': 'D011677', 'term': 'Punctures'}, {'id': 'D013514', 'term': 'Surgical Procedures, Operative'}, {'id': 'D008919', 'term': 'Investigative Techniques'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITHOUT_DNA', 'description': 'intestinal tissue samples blood samples'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2010-01-27', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2020-08', 'completionDateStruct': {'date': '2011-05-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2020-08-19', 'studyFirstSubmitDate': '2020-08-19', 'studyFirstSubmitQcDate': '2020-08-19', 'lastUpdatePostDateStruct': {'date': '2020-08-24', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2020-08-24', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2011-05-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'messenger ribonucleic acid (mRNA) quantification in intestinal tissue biopsy', 'timeFrame': 'single time-point at baseline', 'description': 'mRNA quantification in intestinal tissue biopsy: mRNA content coding for regulatory RAS protein is measured relative to the mRNA content, which codes for the structural protein villin.'}, {'measure': 'amino acid concentration in blood sample', 'timeFrame': 'single time-point at baseline', 'description': 'amino acid concentration in blood sample by High Performance Liquid Chromatography (HPLC)'}, {'measure': 'amino acid concentration in urine sample', 'timeFrame': 'single time-point at baseline', 'description': 'amino acid concentration in urine sample by HPLC (High Performance Liquid Chromatography)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['Renin Angiotensin System', 'Angiotensin Converting Enzyme 2 (ACE2)', 'Angiotensin II AT1 Receptor Blocker', 'ACE inhibitors', 'intestinal amino acid absorption'], 'conditions': ['Renin-Angiotensin Aldosterone System (RAS)']}, 'descriptionModule': {'briefSummary': 'This study is to find out what role a local intestinal RAS (renin angiotensin system) plays in the context of amino acid absorption in the human intestinal tract and how this RAS and thus the amino acid absorption is influenced by the RAS-active drugs (angiotensin II AT1 receptor blockers (sartans) or ACE inhibitors).'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients undertaking a gastroscopy and / or colonoscopy for a medical indication', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Body Mass Index (BMI): 18-35 kg/m2\n* cohort 1: therapy with an angiotensin II AT1 antagonist or ACE Inhibitor\n* cohort 2: no therapy with an angiotensin II AT1 antagonist or ACE Inhibitor\n* Carrying out a diagnostic gastroscopy, colonoscopy or a combined gastroscopy / colonoscopy\n* Existence of written consent after detailed information about the study\n\nExclusion Criteria:\n\n* Severe pathological changes in the gastrointestinal tract (e.g. sprue, stomach ulcers, malignancies); (reflux esophagitis and gastritis are not Exclusion criteria)\n* History of gastrointestinal tract surgery (except for appendectomy and inguinal hernia surgery)\n* History of malignancy\n* Severe acute and chronic organ diseases requiring treatment (e.g. kidney replacement therapy)\n* Patients with an increased risk of bleeding (e.g. oral anticoagulation, coagulation disorders)\n* Drug or alcohol abuse\n* Mental impairment limiting the ability to meet all study requirements'}, 'identificationModule': {'nctId': 'NCT04524494', 'briefTitle': 'Human Intestinal Amino Acid Absorption and the Role of a Local RAS', 'organization': {'class': 'OTHER', 'fullName': "University Children's Hospital Basel"}, 'officialTitle': 'Human Intestinal Amino Acid Absorption and the Role of a Local (Renin)-Angiotensin System (RAS)', 'orgStudyIdInfo': {'id': 'EK1744; ks20Vuille'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'RAS- active medication', 'description': 'Patients taking RAS- active medication (ACE- Inhibitor, Angiotensin II AT1 Antagonist (Sartan)) on a daily Basis for at least 6 months for medical reasons', 'interventionNames': ['Other: biopsy of intestinal tissue', 'Other: blood draw', 'Other: urine collection']}, {'label': 'no RAS- active medication', 'description': 'Patients not taking RAS- active medication', 'interventionNames': ['Other: biopsy of intestinal tissue', 'Other: blood draw', 'Other: urine collection']}], 'interventions': [{'name': 'biopsy of intestinal tissue', 'type': 'OTHER', 'description': '4 intestinal tissue biopsies taken from descending Duodenum, 2 intestinal tissue biopsies taken from Ileum, 2 intestinal tissue biopsies taken from ascending colon (additional to routine biopsies taken for gastrointestinal diagnostic)', 'armGroupLabels': ['RAS- active medication', 'no RAS- active medication']}, {'name': 'blood draw', 'type': 'OTHER', 'description': '40 ml blood draw (in Heparin blood tubes) (additional to routine blood draw taken for gastrointestinal diagnostic)', 'armGroupLabels': ['RAS- active medication', 'no RAS- active medication']}, {'name': 'urine collection', 'type': 'OTHER', 'description': 'Midstream Urine collection', 'armGroupLabels': ['RAS- active medication', 'no RAS- active medication']}]}, 'contactsLocationsModule': {'locations': [{'zip': '4031', 'city': 'Basel', 'country': 'Switzerland', 'facility': 'Universitäts-Kinderspital beider Basel (UKBB)', 'geoPoint': {'lat': 47.55839, 'lon': 7.57327}}, {'zip': '8091', 'city': 'Zurich', 'country': 'Switzerland', 'facility': 'UniversitätsSpital Zürich', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}], 'overallOfficials': [{'name': 'Raphael N Vuille-dit-Bille, Dr. med.', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Universitäts-Kinderspital beider Basel (UKBB)'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': "University Children's Hospital Basel", 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}