Clinical Trial To Evaluate The Effect Of Valsartan On Insulin Sensitivity In Subjects With Impaired Glucose Tolerance

Phase 4

Completed

• Conditions: Hypertension; Impaired Glucose Tolerance

• Registration Number: NCT00241072
• Lead Sponsor: Novartis

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.

Detailed Description

Not available

Study Timeline

• Study Start: 2002-09
• Primary Completion: 2005-07
• Study Completion: 2005-07
• Study First Submitted: 2005-10-14
• Study First Submitted QC: 2005-10-17
• Study First Posted: 2005-10-18
• Status Verified: 2012-05
• Last Update Submitted: 2012-05-03
• Last Update Posted: 2012-05-04

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 27

Inclusion Criteria

history or presenting hypertension Elevated fasting blood glucose levels -

Exclusion Criteria

Pregnancy potential Diabetes mellitus

Other criteria apply

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
Change from baseline insulin sensitivity after 24 weeks

Secondary Outcome Measures

Name	Time	Method
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