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

Completed

• Conditions: Renin-Angiotensin Aldosterone System (RAS)
• Interventions: Other: biopsy of intestinal tissue; Other: blood draw; Other: urine collection

• Registration Number: NCT04524494
• Lead Sponsor: University Children's Hospital Basel

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).

Detailed Description

Not available

Study Timeline

• Study Start: 2010-01-27
• Primary Completion: 2011-05-31
• Study Completion: 2011-05-31
• Status Verified: 2020-08
• Study First Submitted: 2020-08-19
• Study First Submitted QC: 2020-08-19
• Last Update Submitted: 2020-08-19
• Study First Posted: 2020-08-24
• Last Update Posted: 2020-08-24

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
no RAS- active medication	urine collection	Patients not taking RAS- active medication
RAS- active medication	biopsy of intestinal tissue	Patients taking RAS- active medication (ACE- Inhibitor, Angiotensin II AT1 Antagonist (Sartan)) on a daily Basis for at least 6 months for medical reasons
RAS- active medication	blood draw	Patients taking RAS- active medication (ACE- Inhibitor, Angiotensin II AT1 Antagonist (Sartan)) on a daily Basis for at least 6 months for medical reasons
RAS- active medication	urine collection	Patients taking RAS- active medication (ACE- Inhibitor, Angiotensin II AT1 Antagonist (Sartan)) on a daily Basis for at least 6 months for medical reasons
no RAS- active medication	biopsy of intestinal tissue	Patients not taking RAS- active medication
no RAS- active medication	blood draw	Patients not taking RAS- active medication

Primary Outcome Measures

Name	Time	Method
messenger ribonucleic acid (mRNA) quantification in intestinal tissue biopsy	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.
amino acid concentration in blood sample	single time-point at baseline	amino acid concentration in blood sample by High Performance Liquid Chromatography (HPLC)
amino acid concentration in urine sample	single time-point at baseline	amino acid concentration in urine sample by HPLC (High Performance Liquid Chromatography)

Trial Locations

Locations (2)

Universitäts-Kinderspital beider Basel (UKBB); 🇨🇭 Basel, Switzerland

UniversitätsSpital Zürich; 🇨🇭 Zürich, Switzerland