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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Zurich
ClinicalTrials.gov Identifier:
NCT01252368
First received: November 30, 2010
Last updated: November 28, 2012
Last verified: November 2012
History of Changes
  Purpose

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.


Condition Intervention
Healthy Participants
Hypertension
 Biological: hypertension

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Human Intestinal Amino Acid Absorption and the Role of a Local (Renin)-Angiotensin System (RAS)

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University of Zurich:

Enrollment: 48
Study Start Date: December 2009
Study Completion Date: May 2011
Groups/Cohorts Assigned Interventions
RAS active drugs
ACE inhibitors and sartanes
 Biological: hypertension
patients taking daily ACE inhibitors or sartanes
healthy participants

  Eligibility

Ages Eligible for Study:   18 Years to 80 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population

Patients attending the hospital for clarification of gastrointestinal symptoms by gastroduodenoscopy or colonoscopy

Criteria

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:

  • 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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01252368

Locations
Switzerland
University Hospital Zurich, Gastroenterology and Hepatology
Zurich, ZH, Switzerland, 8091
Sponsors and Collaborators
University of Zurich
Investigators
Principal Investigator: Werner Schwizer, Professor MD University Hospital Zurich, Gastroenterology and Hepatology
  More Information

No publications provided

Responsible Party: University of Zurich
ClinicalTrials.gov Identifier: NCT01252368     History of Changes
Other Study ID Numbers: EK-1744
Study First Received: November 30, 2010
Last Updated: November 28, 2012
Health Authority: Switzerland: Swissmedic

Additional relevant MeSH terms:
Hypertension
Vascular Diseases
Cardiovascular Diseases
Angiotensin-Converting Enzyme Inhibitors
 Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions

ClinicalTrials.gov processed this record on May 21, 2013