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NCT00905528 Clinical Trial

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

Type 2 Diabetes Mellitus Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data
NCT number NCT00905528
Other study ID # Re.-No. 3204
Secondary ID SFB TP B5
Status Completed
Phase N/A
First received May 19, 2009
Last updated March 24, 2015
Start date January 2002
Est. completion date December 2004

Study information
Verified date March 2015
Source University of Erlangen-Nürnberg Medical School
Contact n/a
Is FDA regulated No
Health authority Germany: Federal Institute for Drugs and Medical Devices
Study type Observational

Clinical Trial 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.

Recruitment information / eligibility
Status Completed
Enrollment 69
Est. completion date December 2004
Est. primary completion date December 2004
Accepts healthy volunteers No
Gender Both
Age group 30 Years to 80 Years
Eligibility Inclusion Criteria:

- Type 2 Diabetes mellitus

Exclusion Criteria:

- Macroalbuminuria

- Symptomatic cardiovascular disease

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

Intervention

Drug:
• Telmisartan 80 mg/d

• Ramipril 10 mg/d

Locations
Country Name City State
Germany University of Erlangen-Nuremberg Erlangen Bavaria

Sponsors (1)
Lead Sponsor Collaborator
University of Erlangen-Nürnberg Medical School

Country where clinical trial is conducted

Germany, 

References & Publications (2)

Ritt M, Ott C, Delles C, Schneider MP, Schmieder RE. Impact of the endothelial nitric oxide synthase gene G894T polymorphism on renal endothelial function in patients with type 2 diabetes. Pharmacogenet Genomics. 2008 Aug;18(8):699-707. doi: 10.1097/FPC.0b013e32830500b1. — View Citation

Ritt M, Ott C, Raff U, Schneider MP, Schuster I, Hilgers KF, Schlaich MP, Schmieder RE. Renal vascular endothelial function in hypertensive patients with type 2 diabetes mellitus. Am J Kidney Dis. 2009 Feb;53(2):281-9. doi: 10.1053/j.ajkd.2008.10.041. Epu — View Citation

Outcome
Type Measure Description Time frame Safety issue
Primary Change in eGFR after 1 year
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