NCT01252368

Brief 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. 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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
48

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Dec 2009

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

December 1, 2009

Completed
12 months until next milestone

First Submitted

Initial submission to the registry

November 30, 2010

Completed
3 days until next milestone

First Posted

Study publicly available on registry

December 3, 2010

Completed
5 months until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2011

Completed
Last Updated

November 29, 2012

Status Verified

November 1, 2012

First QC Date

November 30, 2010

Last Update Submit

November 28, 2012

Conditions

Study Arms (2)

RAS active drugs

ACE inhibitors and sartanes

Biological: hypertension

healthy participants

Interventions

hypertensionBIOLOGICAL

patients taking daily ACE inhibitors or sartanes

RAS active drugs

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodProbability Sample
Study Population

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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

University Hospital Zurich, Gastroenterology and Hepatology

Zurich, Canton of Zurich, 8091, Switzerland

Location

MeSH Terms

Conditions

Hypertension

Condition Hierarchy (Ancestors)

Vascular DiseasesCardiovascular Diseases

Study Officials

  • Werner Schwizer, Professor MD

    University Hospital Zurich, Gastroenterology and Hepatology

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

November 30, 2010

First Posted

December 3, 2010

Study Start

December 1, 2009

Study Completion

May 1, 2011

Last Updated

November 29, 2012

Record last verified: 2012-11

Locations