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

Renin-Angiotensin Aldosterone System (RAS) Clinical Trial

Official title:

Human Intestinal Amino Acid Absorption and the Role of a Local (Renin)-Angiotensin System (RAS)

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04524494
• Other study ID #: EK1744; ks20Vuille
• Status: Completed
• Start date: January 27, 2010
• Est. completion date: May 31, 2011

Study information

• Verified date: August 2020
• Source: University Children's Hospital Basel
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: May 31, 2011
• Est. primary completion date: May 31, 2011
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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

Related Conditions & MeSH terms

• Renin-Angiotensin Aldosterone System (RAS)

Intervention

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)
• blood draw
40 ml blood draw (in Heparin blood tubes) (additional to routine blood draw taken for gastrointestinal diagnostic)
• urine collection
Midstream Urine collection

Locations

Country	Name	City	State
Switzerland	Universitäts-Kinderspital beider Basel (UKBB)	Basel
Switzerland	UniversitätsSpital Zürich	Zürich

Sponsors (1)

Lead Sponsor	Collaborator
University Children's Hospital Basel

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	messenger ribonucleic acid (mRNA) quantification in intestinal tissue biopsy	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.	single time-point at baseline
Primary	amino acid concentration in blood sample	amino acid concentration in blood sample by High Performance Liquid Chromatography (HPLC)	single time-point at baseline
Primary	amino acid concentration in urine sample	amino acid concentration in urine sample by HPLC (High Performance Liquid Chromatography)	single time-point at baseline