Healthy ParticipantsNCT01252368
Human Intestinal Amino Acid Absorption and the Role of a Local (Renin)-Angiotensin System (RAS)
An observational study of Healthy Participants and Hypertension, run by University of Zurich at 1 site in Switzerland.
Trial summary
Aim of this trial is to investigate the expression and localisation of different amino acid transporters and their regulatory proteins derived from the regulatory proteins of the local renin angiotensin system (RAS) in the intestine. Read more about this study
- Who is it for?
- Ages 18 to 80 yearsHealthy volunteers can take part
- Conditions the study is for
- Healthy Participants, Hypertension
- What is being tested?
- hypertension
- How many people
- 48 participants
- Where
- 1 siteSwitzerland
- Study dates
- Dec 2009to 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 attending the hospital for clarification of gastrointestinal symptoms by gastroduodenoscopy or colonoscopy
Who may be able to join
- Men and women aged 18-80 years
- BMI 18-35 kg/m2
- Group 1: patients taking daily RAS-active drugs, like ACE inhibitors or sartanes (treatment indication outside of this study)
- Group 2: no therapy with RAS-active drugs, like ACE inhibitors or sartanes Gastroduodenoscopy and/or colonoscopy with a treatment indication outside of this study
- Informed consent
Who cannot join
- Severe pathologic alterations in the gastrointestinal tract (ulcers, tumors, celiac disease; GERD and gastritis are no exclusion criteria)
- Status after operations of the gastrointestinal tract (except uncomplicated appendectomy or inguinal hernia repair)
- Patients with malignant diseases
- Severe acute or chronic diseases which require treatment (e.g. renal replacement therapy)
- Patients with increased bleeding risk (e.g. oral anticoagulation, coagulopathy)
- Drug or alcohol abuse
- Mental disorders which limits the ability to fulfil all study requirements
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
University Hospital Zurich, Gastroenterology and Hepatology
Zurich, Canton of Zurich, 8091
About this study
Aim of this trial is to investigate the expression and localisation of different amino acid transporters and their regulatory proteins derived from the regulatory proteins of the local renin angiotensin system (RAS) in the intestine. This is investigated on one hand in patients who do not take any drugs interfering with RAS. On the other hand expression analysis is done in patients taking daily RAS-active drugs, like ACE inhibitors or sartanes.
After obtaining informed consent of patients attending the hospital for clarification of gastrointestinal symptoms by gastroduodenoscopy or colonoscopy, 2 biopsies (in addition to biopsies needed for clinical diagnostics) will be taken from each duodenum, jejunum, ileum and descending colon.
Read more
Biopsies are investigated anonymously at the Institute of Physiology of the University of Zurich. The mRNA content of amino acid transporters and regulatory proteins, respectively, in the biopsies is analyzed by quantitative PCR. Transport proteins are in addition analyzed with immunohistochemistry.
Furthermore amino acid concentration in plasma and urine samples are analyzed by HPLC. From plasma and serum samples RAS parameters like renin, aldosterone, ACE and angiotensin(1-7) are measured.
- Conditions
- Healthy Participants, Hypertension
- Being tested
- hypertension
- Medical subject headings
- Hypertension
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hypertensionBiological
patients taking daily ACE inhibitors or sartanes
| Study group | Role | What they receive |
|---|---|---|
| RAS active drugs | ACE inhibitors and sartanes Receives: Biological: hypertension | |
| healthy participants | Not described |
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2010 (estimated)
- Study startDec 2009
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Healthy ParticipantsStudies of the same condition, open and under way.
- More trials run by University of ZurichThe sponsor's other registered studies.
- 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Zurich
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Werner Schwizer, Professor MD, Principal investigator, University Hospital Zurich, Gastroenterology and Hepatology
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01252368
- Sponsor's protocol ID
- EK-1744
- Status last verified
- Nov 2012
- First submitted
- 30 Nov 2010
- Last updated
- 29 Nov 2012
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 29 Nov 2012. 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
- NCT01252368
- Acronym / sponsor ID
- EK-1744
- Conditions
- Healthy Participants, Hypertension
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- University of ZurichUniversity, hospital or other
- Study start
- Dec 2009
- Study completion
- May 2011 (actual)
- First posted
- 3 Dec 2010 (estimated)
- 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.
Aim of this trial is to investigate the expression and localisation of different amino acid transporters and their regulatory proteins derived from the regulatory proteins of the local renin angiotensin system (RAS) in the intestine. This is investigated on one hand in patients who do not take any drugs interfering with RAS. On the other hand expression analysis is done in patients taking daily RAS-active drugs, like ACE inhibitors or sartanes.
After obtaining informed consent of patients attending the hospital for clarification of gastrointestinal symptoms by gastroduodenoscopy or colonoscopy, 2 biopsies (in addition to biopsies needed for clinical diagnostics) will be taken from each duodenum, jejunum, ileum and descending colon.
Biopsies are investigated anonymously at the Institute of Physiology of the University of Zurich. The mRNA content of amino acid transporters and regulatory proteins, respectively, in the biopsies is analyzed by quantitative PCR. Transport proteins are in addition analyzed with immunohistochemistry.
Furthermore amino acid concentration in plasma and urine samples are analyzed by HPLC. From plasma and serum samples RAS parameters like renin, aldosterone, ACE and angiotensin(1-7) are measured.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| RAS active drugs | – | Biological: hypertensionACE inhibitors and sartanes |
| healthy participants | – | – |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Patients attending the hospital for clarification of gastrointestinal symptoms by gastroduodenoscopy or colonoscopy
Key inclusion criteria (5 listed)
- Men and women aged 18-80 years
- BMI 18-35 kg/m2
- Group 1: patients taking daily RAS-active drugs, like ACE inhibitors or sartanes (treatment indication outside of this study)
- Group 2: no therapy with RAS-active drugs, like ACE inhibitors or sartanes Gastroduodenoscopy and/or colonoscopy with a treatment indication outside of this study
- Informed consent
Key exclusion criteria (7 listed)
- Severe pathologic alterations in the gastrointestinal tract (ulcers, tumors, celiac disease; GERD and gastritis are no exclusion criteria)
- Status after operations of the gastrointestinal tract (except uncomplicated appendectomy or inguinal hernia repair)
- Patients with malignant diseases
- Severe acute or chronic diseases which require treatment (e.g. renal replacement therapy)
- Patients with increased bleeding risk (e.g. oral anticoagulation, coagulopathy)
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 |
|---|---|---|
| hypertensionpatients taking daily ACE inhibitors or sartanes | Biological | RAS active drugs |
Primary outcome
Not reported in the source record.
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 29 Nov 2012.
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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.
Werner Schwizer, Professor MD principal investigator
University Hospital Zurich, Gastroenterology and Hepatology
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Healthy Participants and Hypertension, run by University of Zurich at 1 site 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 29 Nov 2012. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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.
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 29 Nov 2012.