Ignite Creation Date:
2025-12-24 @ 5:50 PM
Ignite Modification Date:
2025-12-27 @ 11:46 PM
Study NCT ID:
NCT01252368
Status:
COMPLETED
Last Update Posted:
2012-11-29
First Post:
2010-11-30
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Human Intestinal Amino Acid Absorption and the Role of a Local (Renin)-Angiotensin System (RAS)
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'CASE_CONTROL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 48}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2009-12'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2012-11', 'completionDateStruct': {'date': '2011-05', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2012-11-28', 'studyFirstSubmitDate': '2010-11-30', 'studyFirstSubmitQcDate': '2010-12-02', 'lastUpdatePostDateStruct': {'date': '2012-11-29', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2010-12-03', 'type': 'ESTIMATED'}}, 'conditionsModule': {'conditions': ['Healthy Participants', 'Hypertension']}, 'descriptionModule': {'briefSummary': 'Aim of this trial is to investigate the expression and localisation of different amino acid transporters and their regulatory proteins derived from the regulatory proteins of the local renin angiotensin system (RAS) in the intestine. This is investigated on one hand in patients who do not take any drugs interfering with RAS. On the other hand expression analysis is done in patients taking daily RAS-active drugs, like ACE inhibitors or sartanes.\n\nAfter obtaining informed consent of patients attending the hospital for clarification of gastrointestinal symptoms by gastroduodenoscopy or colonoscopy, 2 biopsies (in addition to biopsies needed for clinical diagnostics) will be taken from each duodenum, jejunum, ileum and descending colon.\n\nBiopsies are investigated anonymously at the Institute of Physiology of the University of Zurich. The mRNA content of amino acid transporters and regulatory proteins, respectively, in the biopsies is analyzed by quantitative PCR. Transport proteins are in addition analyzed with immunohistochemistry.\n\nFurthermore amino acid concentration in plasma and urine samples are analyzed by HPLC. From plasma and serum samples RAS parameters like renin, aldosterone, ACE and angiotensin(1-7) are measured.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '80 Years', 'minimumAge': '18 Years', 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': 'Patients attending the hospital for clarification of gastrointestinal symptoms by gastroduodenoscopy or colonoscopy', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion criteria:\n\n* Men and women aged 18-80 years\n* BMI 18-35 kg/m2\n* Group 1: patients taking daily RAS-active drugs, like ACE inhibitors or sartanes (treatment indication outside of this study)\n* Group 2: no therapy with RAS-active drugs, like ACE inhibitors or sartanes Gastroduodenoscopy and/or colonoscopy with a treatment indication outside of this study\n* Informed consent\n\nExclusion criteria:\n\n* Severe pathologic alterations in the gastrointestinal tract (ulcers, tumors, celiac disease; GERD and gastritis are no exclusion criteria)\n* Status after operations of the gastrointestinal tract (except uncomplicated appendectomy or inguinal hernia repair)\n* Patients with malignant diseases\n* Severe acute or chronic diseases which require treatment (e.g. renal replacement therapy)\n* Patients with increased bleeding risk (e.g. oral anticoagulation, coagulopathy)\n* Drug or alcohol abuse\n* Mental disorders which limits the ability to fulfil all study requirements'}, 'identificationModule': {'nctId': 'NCT01252368', 'briefTitle': 'Human Intestinal Amino Acid Absorption and the Role of a Local (Renin)-Angiotensin System (RAS)', 'organization': {'class': 'OTHER', 'fullName': 'University of Zurich'}, 'officialTitle': 'Human Intestinal Amino Acid Absorption and the Role of a Local (Renin)-Angiotensin System (RAS)', 'orgStudyIdInfo': {'id': 'EK-1744'}}, 'armsInterventionsModule': {'armGroups': [{'label': 'RAS active drugs', 'description': 'ACE inhibitors and sartanes', 'interventionNames': ['Biological: hypertension']}, {'label': 'healthy participants'}], 'interventions': [{'name': 'hypertension', 'type': 'BIOLOGICAL', 'description': 'patients taking daily ACE inhibitors or sartanes', 'armGroupLabels': ['RAS active drugs']}]}, 'contactsLocationsModule': {'locations': [{'zip': '8091', 'city': 'Zurich', 'state': 'Canton of Zurich', 'country': 'Switzerland', 'facility': 'University Hospital Zurich, Gastroenterology and Hepatology', 'geoPoint': {'lat': 47.36667, 'lon': 8.55}}], 'overallOfficials': [{'name': 'Werner Schwizer, Professor MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University Hospital Zurich, Gastroenterology and Hepatology'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Zurich', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}