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

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ClinicalTrials.gov Identifier: NCT00905528
Recruitment Status : Completed
First Posted : May 20, 2009
Last Update Posted : March 25, 2015
Sponsor:
Information provided by (Responsible Party):
University of Erlangen-Nürnberg Medical School

Brief Summary:
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 or disease Intervention/treatment
Type 2 Diabetes Mellitus Drug: Telmisartan 80 mg/d Drug: Ramipril 10 mg/d

Study Type : Observational
Estimated Enrollment : 69 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Prospective Study on Endothelial Function in Subjects With Type 2 Diabetes Mellitus
Study Start Date : January 2002
Actual Primary Completion Date : December 2004
Actual Study Completion Date : December 2004

Resource links provided by the National Library of Medicine

Drug Information available for: Ramipril
U.S. FDA Resources

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



Primary Outcome Measures :
  1. Change in eGFR after 1 year


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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

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

Publications of Results:
Other 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 Posted: May 20, 2009    Key Record Dates
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