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Human Intestinal Amino Acid Absorption and the Role of a Local RAS

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ClinicalTrials.gov Identifier: NCT04524494
Recruitment Status : Completed
First Posted : August 24, 2020
Last Update Posted : August 24, 2020
Sponsor:
Information provided by (Responsible Party):
University Children's Hospital Basel

Study Description
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Brief Summary:
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).

Condition or disease Intervention/treatment
Renin-Angiotensin Aldosterone System (RAS) Other: biopsy of intestinal tissue Other: blood draw Other: urine collection

Study Design
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Study Type : Observational
Actual Enrollment : 50 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Human Intestinal Amino Acid Absorption and the Role of a Local (Renin)-Angiotensin System (RAS)
Actual Study Start Date : January 27, 2010
Actual Primary Completion Date : May 31, 2011
Actual Study Completion Date : May 31, 2011

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Groups and Cohorts
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Group/Cohort Intervention/treatment
RAS- active medication
Patients taking RAS- active medication (ACE- Inhibitor, Angiotensin II AT1 Antagonist (Sartan)) on a daily Basis for at least 6 months for medical reasons
 Other: biopsy of intestinal tissue
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)

Other: blood draw
40 ml blood draw (in Heparin blood tubes) (additional to routine blood draw taken for gastrointestinal diagnostic)

Other: urine collection
Midstream Urine collection
no RAS- active medication
Patients not taking RAS- active medication
 Other: biopsy of intestinal tissue
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)

Other: blood draw
40 ml blood draw (in Heparin blood tubes) (additional to routine blood draw taken for gastrointestinal diagnostic)

Other: urine collection
Midstream Urine collection


Outcome Measures
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Primary Outcome Measures :
  1. messenger ribonucleic acid (mRNA) quantification in intestinal tissue biopsy [ Time Frame: single time-point at baseline ]
    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.

  2. amino acid concentration in blood sample [ Time Frame: single time-point at baseline ]
    amino acid concentration in blood sample by High Performance Liquid Chromatography (HPLC)

  3. amino acid concentration in urine sample [ Time Frame: single time-point at baseline ]
    amino acid concentration in urine sample by HPLC (High Performance Liquid Chromatography)


Biospecimen Retention:   Samples Without DNA
intestinal tissue samples blood samples

Eligibility Criteria
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Ages Eligible for Study:   18 Years to 80 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Patients undertaking a gastroscopy and / or colonoscopy for a medical indication
Criteria

Inclusion Criteria:

  • Body Mass Index (BMI): 18-35 kg/m2
  • cohort 1: therapy with an angiotensin II AT1 antagonist or ACE Inhibitor
  • cohort 2: no therapy with an angiotensin II AT1 antagonist or ACE Inhibitor
  • Carrying out a diagnostic gastroscopy, colonoscopy or a combined gastroscopy / colonoscopy
  • Existence of written consent after detailed information about the study

Exclusion Criteria:

  • Severe pathological changes in the gastrointestinal tract (e.g. sprue, stomach ulcers, malignancies); (reflux esophagitis and gastritis are not Exclusion criteria)
  • History of gastrointestinal tract surgery (except for appendectomy and inguinal hernia surgery)
  • History of malignancy
  • Severe acute and chronic organ diseases requiring treatment (e.g. kidney replacement therapy)
  • Patients with an increased risk of bleeding (e.g. oral anticoagulation, coagulation disorders)
  • Drug or alcohol abuse
  • Mental impairment limiting the ability to meet all study requirements
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04524494


Locations
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Switzerland
Universitäts-Kinderspital beider Basel (UKBB)
Basel, Switzerland, 4031
UniversitätsSpital Zürich
Zürich, Switzerland, 8091
Sponsors and Collaborators
University Children's Hospital Basel
Investigators
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Principal Investigator: Raphael N Vuille-dit-Bille, Dr. med. Universitäts-Kinderspital beider Basel (UKBB)
More Information
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Responsible Party: University Children's Hospital Basel
ClinicalTrials.gov Identifier: NCT04524494    
Other Study ID Numbers: EK1744; ks20Vuille
First Posted: August 24, 2020    Key Record Dates
Last Update Posted: August 24, 2020
Last Verified: August 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by University Children's Hospital Basel:
Renin Angiotensin System
Angiotensin Converting Enzyme 2 (ACE2)
Angiotensin II AT1 Receptor Blocker
ACE inhibitors
intestinal amino acid absorption