A Single Center, Open Label, Single Arm Trial To Evaluate The Effect Of Twenty Four Weeks Of Treatment With 80 Mg To 320 Mg Valsartan On Insulin Sensitivity In Subjects With Impaired Glucose Tolerance (Igt)

Novartis0 sites27 target enrollmentSeptember 2002

ConditionsHypertension Impaired Glucose Tolerance

Drugsvalsartan

Overview

Phase: Phase 4
Intervention: Not specified
Conditions: Hypertension
Sponsor: Novartis
Enrollment: 27
Primary Endpoint: Change from baseline insulin sensitivity after 24 weeks
Status: Completed
Last Updated: 14 years ago

Overview Investigators Eligibility Criteria Outcomes Similar Trials

Overview

Brief Summary

THE PURPOSE OF THIS STUDY IS TO DETERMINE IF 24 WEEKS OF TREATMENT WITH VALSARTAN (80 MG - 320 MG) IMPROVES INSULIN SENSITIVITY IN SUBJECTS WITH HIGHER THAN NORMAL GLUCOSE LEVELS USING A TEST CALLED THE EUGLYCEMIC CLAMP.

Registry

clinicaltrials.gov

Start Date

September 2002

End Date

July 2005

Last Updated

14 years ago

Study Type

Interventional

Study Design

Single Group

Sex

All

Investigators

Sponsor

Novartis

Responsible Party

Sponsor

Eligibility Criteria

Inclusion Criteria

•history or presenting hypertension Elevated fasting blood glucose levels -

Exclusion Criteria

•Pregnancy potential Diabetes mellitus
•Other criteria apply

Outcomes

Primary Outcomes

Change from baseline insulin sensitivity after 24 weeks

Secondary Outcomes

Change from baseline in the function of cells that line blood vessels after 24 weeks
Change from baseline in markers of vascular inflammation after 24 weeks
Adverse events and serious adverse events at each study visit for 24 weeks
Hematology, blood chemistries, and urine measurements for up to 24 weeks
Vital signs and physical examinations for up to 24 weeks