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

NCT ID: NCT04524494

Last Updated: 2020-08-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

50 participants

Study Classification

OBSERVATIONAL

Study Start Date

2010-01-27

Study Completion Date

2011-05-31

Brief Summary

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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).

Detailed Description

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Conditions

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Renin-Angiotensin Aldosterone System (RAS)

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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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

biopsy of intestinal tissue

Intervention Type OTHER

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)

blood draw

Intervention Type OTHER

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

urine collection

Intervention Type OTHER

Midstream Urine collection

no RAS- active medication

Patients not taking RAS- active medication

biopsy of intestinal tissue

Intervention Type OTHER

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)

blood draw

Intervention Type OTHER

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

urine collection

Intervention Type OTHER

Midstream Urine collection

Interventions

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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)

Intervention Type OTHER

blood draw

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

Intervention Type OTHER

urine collection

Midstream Urine collection

Intervention Type OTHER

Eligibility Criteria

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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

* 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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University Children's Hospital Basel

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Raphael N Vuille-dit-Bille, Dr. med.

Role: PRINCIPAL_INVESTIGATOR

Universitäts-Kinderspital beider Basel (UKBB)

Locations

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Universitäts-Kinderspital beider Basel (UKBB)

Basel, , Switzerland

Site Status

UniversitätsSpital Zürich

Zurich, , Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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EK1744; ks20Vuille

Identifier Type: -

Identifier Source: org_study_id

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