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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
University of Erlangen-Nürnberg Medical School
ClinicalTrials.gov Identifier:
NCT00905528
First received: May 19, 2009
Last updated: June 29, 2012
Last verified: June 2012
History of Changes
  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:

U.S. FDA Resources

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

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

Ages Eligible for Study:   30 Years to 80 Years
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: May 19, 2009
Last Updated: June 29, 2012
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

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
Ramipril
Telmisartan
Angiotensin-Converting Enzyme Inhibitors
Protease Inhibitors
 Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Antihypertensive Agents
Cardiovascular Agents
Therapeutic Uses
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists

ClinicalTrials.gov processed this record on May 16, 2013