TRENDY Follow-up: Study on Endothelial Function in Subjects With Type 2 Diabetes Mellitus

March 24, 2015 updated by: University of Erlangen-Nürnberg Medical School

Prospective Study on Endothelial Function in Subjects With Type 2 Diabetes Mellitus

Basal nitric oxide (NO) activity plays a pivotal role in the regulation of glomerular hemodynamics, and in animal experiments its alteration has been associated with morphological changes characteristic of diabetic nephropathy. The investigators aimed to assess in a prospective study: 1. basal NO activity of renal vasculature and 2. renal hemodynamics to examine whether impairment of basal NO activity of the renal vasculature is related to development and progression of diabetic nephropathy and other cardiovascular endpoints.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Observational

Enrollment (Anticipated)

69

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Germany
    • Bavaria
      • Erlangen, Bavaria, Germany, 91054
        • University of Erlangen-Nuremberg

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

30 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Subjects with type 2 diabetes mellitus and normo or microalbuminuria

Description

Inclusion Criteria:

  • Type 2 Diabetes mellitus

Exclusion Criteria:

  • Macroalbuminuria
  • Symptomatic cardiovascular disease

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
A
Subjects with type 2 diabetes mellitus, eGFR > 80, hypertension, no overt proteinuria
Drug: Telmisartan 80 mg/d
B
Subjects with type 2 diabetes mellitus, eGFR > 80, hypertension, no overt proteinuria
Drug: Ramipril 10 mg/d

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Change in eGFR after 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

University of Erlangen-Nürnberg Medical School

Investigators

  • Principal Investigator: Roland E Schmieder, Prof., Clinical Research Center, Department of Nephrology and Hypertension, University of Erlangen-Nuremberg

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2002

Primary Completion (ACTUAL)

December 1, 2004

Study Completion (ACTUAL)

December 1, 2004

Study Registration Dates

First Submitted

May 19, 2009

First Submitted That Met QC Criteria

May 19, 2009

First Posted (ESTIMATE)

May 20, 2009

Study Record Updates

Last Update Posted (ESTIMATE)

March 25, 2015

Last Update Submitted That Met QC Criteria

March 24, 2015

Last Verified

March 1, 2015

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Re.-No. 3204
  • SFB TP B5

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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