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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00905528
First Posted: May 20, 2009
Last Update Posted: March 25, 2015
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
University of Erlangen-Nürnberg Medical School
  Purpose
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.

Condition Intervention
Type 2 Diabetes Mellitus Drug: Telmisartan 80 mg/d Drug: Ramipril 10 mg/d

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Study on Endothelial Function in Subjects With Type 2 Diabetes Mellitus

Resource links provided by NLM:


Further study details as provided by University of Erlangen-Nürnberg Medical School:

Primary Outcome Measures:
  • Change in eGFR after 1 year

Estimated Enrollment: 69
Study Start Date: January 2002
Study Completion Date: December 2004
Primary Completion Date: December 2004 (Final data collection date for primary outcome measure)
Groups/Cohorts Assigned Interventions
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

  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   30 Years to 80 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Subjects with type 2 diabetes mellitus and normo or microalbuminuria
Criteria

Inclusion Criteria:

  • Type 2 Diabetes mellitus

Exclusion Criteria:

  • Macroalbuminuria
  • Symptomatic cardiovascular disease
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00905528


Locations
Germany
University of Erlangen-Nuremberg
Erlangen, Bavaria, Germany, 91054
Sponsors and Collaborators
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
  More Information

Publications:
Responsible Party: University of Erlangen-Nürnberg Medical School
ClinicalTrials.gov Identifier: NCT00905528     History of Changes
Other Study ID Numbers: Re.-No. 3204
SFB TP B5
First Submitted: May 19, 2009
First Posted: May 20, 2009
Last Update Posted: March 25, 2015
Last Verified: March 2015

Keywords provided by University of Erlangen-Nürnberg Medical School:
type 2 diabetes mellitus
endothelial function
renal hemodynamics

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Telmisartan
Ramipril
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
Enzyme Inhibitors