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

August 19, 2020 updated by: University Children's Hospital Basel

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Observational

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
50

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Switzerland
      • Basel, Switzerland, 4031
        • Universitäts-Kinderspital beider Basel (UKBB)
      • Zürich, Switzerland, 8091
        • Universitatsspital Zurich

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Probability Sample

Study Population

Patients undertaking a gastroscopy and / or colonoscopy for a medical indication

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort

Group / Cohort

A group or subgroup of participants in an observational study that is assessed for biomedical or health outcomes.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
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.
single time-point at baseline
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)
single time-point at baseline
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)
single time-point at baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
University Children's Hospital Basel

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Raphael N Vuille-dit-Bille, Dr. med., Universitäts-Kinderspital beider Basel (UKBB)

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
January 27, 2010

Primary Completion (ACTUAL)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
May 31, 2011

Study Completion (ACTUAL)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
May 31, 2011

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
August 19, 2020

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 19, 2020

First Posted (ACTUAL)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
August 24, 2020

Study Record Updates

Last Update Posted (ACTUAL)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 24, 2020

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 19, 2020

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
August 1, 2020

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • EK1744; ks20Vuille

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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