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

NCT ID: NCT01252368

Last Updated: 2012-11-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

48 participants

Study Classification

OBSERVATIONAL

Study Start Date

2009-12-31

Study Completion Date

2011-05-31

Brief Summary

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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.

Detailed Description

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Conditions

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Healthy Participants Hypertension

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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RAS active drugs

ACE inhibitors and sartanes

hypertension

Intervention Type BIOLOGICAL

patients taking daily ACE inhibitors or sartanes

healthy participants

No interventions assigned to this group

Interventions

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hypertension

patients taking daily ACE inhibitors or sartanes

Intervention Type BIOLOGICAL

Eligibility Criteria

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Inclusion Criteria

* 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

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

80 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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University of Zurich

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Werner Schwizer, Professor MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital Zurich, Gastroenterology and Hepatology

Locations

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University Hospital Zurich, Gastroenterology and Hepatology

Zurich, Canton of Zurich, Switzerland

Site Status

Countries

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Switzerland

Other Identifiers

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EK-1744

Identifier Type: -

Identifier Source: org_study_id