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

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)

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT00241072
Enrollment
27
Registered
2005-10-18
Start date
2002-09-30
Completion date
2005-07-31
Last updated
2012-05-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Hypertension, Impaired Glucose Tolerance

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.

Interventions

DRUGvalsartan

24 WEEKS OF TREATMENT WITH VALSARTAN (80 MG - 320 MG)

Sponsors

Novartis
Lead SponsorINDUSTRY

Study design

Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE

Eligibility

Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
Yes

Inclusion criteria

history or presenting hypertension Elevated fasting blood glucose levels -

Exclusion criteria

Pregnancy potential Diabetes mellitus Other criteria apply \-

Design outcomes

Primary

MeasureTime frame
Change from baseline insulin sensitivity after 24 weeks

Secondary

MeasureTime frame
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

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026