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Completed

NCT Number: NCT04524494

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

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).

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Key information

Conditions

Renin-Angiotensin Aldosterone System (RAS)

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Universitäts-Kinderspital beider Basel (UKBB), Basel, Switzerland

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

biopsy of intestinal tissue

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

Other

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

Urine collection

Other

Midstream Urine collection

Primary outcomes

  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)

Sponsors and collaborators

Lead sponsor

University Children's Hospital Basel

Other

Registry information

Official study title

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

Important dates

Study start
2010
Primary completion
2011
Study completion
2011
First posted
Aug 24, 2020
Registry last updated
Aug 24, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.