Renin-Angiotensin Aldosterone System (RAS)NCT04524494
Human Intestinal Amino Acid Absorption and the Role of a Local RAS
An observational study of Renin-Angiotensin Aldosterone System (RAS), run by University Children's Hospital Basel at 2 sites in Switzerland.
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). Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Renin-Angiotensin Aldosterone System (RAS)
- What is being tested?
- biopsy of intestinal tissue, blood draw and urine collection
- How many people
- 50 participants
- Where
- 2 sitesSwitzerland
- Study dates
- 27 Jan 2010to 31 May 2011
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 80 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Patients undertaking a gastroscopy and / or colonoscopy for a medical indication
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
2 sites in 1 country.
Switzerland2 sites
Universitäts-Kinderspital beider Basel (UKBB)
Basel, 4031
UniversitätsSpital Zürich
Zurich, 8091
About this study
Official title: 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).
- Being tested
- biopsy of intestinal tissue, blood draw, urine collection
- Keywords
- Renin Angiotensin System, Angiotensin Converting Enzyme 2 (ACE2), Angiotensin II AT1 Receptor Blocker, ACE inhibitors, intestinal amino acid absorption
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
biopsy of intestinal tissueOther
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 drawOther
40 ml blood draw (in Heparin blood tubes) (additional to routine blood draw taken for gastrointestinal diagnostic)
urine collectionOther
Midstream Urine collection
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Other: biopsy of intestinal tissue; Other: blood draw; Other: urine collection | |
| no RAS- active medication | Patients not taking RAS- active medication Receives: Other: biopsy of intestinal tissue; Other: blood draw; Other: urine collection |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: single time-point at baseline
amino acid concentration in blood sample
amino acid concentration in blood sample by High Performance Liquid Chromatography (HPLC)
Measured: single time-point at baseline
amino acid concentration in urine sample
amino acid concentration in urine sample by HPLC (High Performance Liquid Chromatography)
Measured: single time-point at baseline
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Aug 2020
- Study start27 Jan 2010
- Primary completion31 May 2011
- Study completion31 May 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Renin-Angiotensin Aldosterone System (RAS)Studies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Children's Hospital Basel
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Raphael N Vuille-dit-Bille, Dr. med., Principal investigator, Universitäts-Kinderspital beider Basel (UKBB)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04524494
- Sponsor's protocol ID
- EK1744; ks20Vuille
- Status last verified
- Aug 2020
- First submitted
- 19 Aug 2020
- Last updated
- 24 Aug 2020
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Human Intestinal Amino Acid Absorption and the Role of a Local (Renin)-Angiotensin System (RAS)
- ClinicalTrials.gov ID
- NCT04524494
- Acronym / sponsor ID
- EK1744; ks20Vuille
- Keywords
- Renin Angiotensin System, Angiotensin Converting Enzyme 2 (ACE2), Angiotensin II AT1 Receptor Blocker, ACE inhibitors, intestinal amino acid absorption
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- University Children's Hospital BaselUniversity, hospital or other
- Study start
- 27 Jan 2010 (actual)
- Primary completion
- 31 May 2011 (actual)
- Study completion
- 31 May 2011 (actual)
- First posted
- 24 Aug 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RAS- active medication | – | Other: biopsy of intestinal tissue, Other: blood draw, Other: urine collectionPatients 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 | – | Other: biopsy of intestinal tissue, Other: blood draw, Other: urine collectionPatients not taking RAS- active medication |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients undertaking a gastroscopy and / or colonoscopy for a medical indication
Key inclusion criteria (5 listed)
- 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
Key exclusion criteria (7 listed)
- 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)
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| biopsy of intestinal tissue4 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 | RAS- active medication, no RAS- active medication |
| blood draw40 ml blood draw (in Heparin blood tubes) (additional to routine blood draw taken for gastrointestinal diagnostic) | Other | RAS- active medication, no RAS- active medication |
| urine collectionMidstream Urine collection | Other | RAS- active medication, no RAS- active medication |
Primary outcome
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.
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)
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)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2020.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Raphael N Vuille-dit-Bille, Dr. med. principal investigator
Universitäts-Kinderspital beider Basel (UKBB)
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Renin-Angiotensin Aldosterone System (RAS), run by University Children's Hospital Basel at 2 sites in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 24 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
messenger ribonucleic acid (mRNA) quantification in intestinal tissue biopsy (time frame: single time-point at baseline). The study lists 3 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Aug 2020.