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

This study has been completed.
Sponsor:
ClinicalTrials.gov Identifier:
NCT00241072
First Posted: October 18, 2005
Last Update Posted: May 4, 2012
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by (Responsible Party):
Novartis
  Purpose
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.

Condition Intervention Phase
Hypertension Impaired Glucose Tolerance Drug: valsartan Phase 4

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: 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)

Resource links provided by NLM:


Further study details as provided by Novartis:

Primary Outcome Measures:
  • Change from baseline insulin sensitivity after 24 weeks

Secondary Outcome Measures:
  • 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

Enrollment: 27
Study Start Date: September 2002
Study Completion Date: July 2005
Primary Completion Date: July 2005 (Final data collection date for primary outcome measure)
Intervention Details:
    Drug: valsartan
    24 WEEKS OF TREATMENT WITH VALSARTAN (80 MG - 320 MG)
  Eligibility

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

history or presenting hypertension Elevated fasting blood glucose levels -

Exclusion Criteria:

Pregnancy potential Diabetes mellitus

Other criteria apply

  Contacts and Locations
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): NCT00241072


Sponsors and Collaborators
Novartis
Investigators
Study Director: Novartis Pharmaceuticals Novartis Pharmaceuticals
  More Information

Responsible Party: Novartis
ClinicalTrials.gov Identifier: NCT00241072     History of Changes
Other Study ID Numbers: CVAL489A2412
First Submitted: October 14, 2005
First Posted: October 18, 2005
Last Update Posted: May 4, 2012
Last Verified: May 2012

Additional relevant MeSH terms:
Insulin Resistance
Glucose Intolerance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Hyperglycemia
Valsartan
Insulin
Antihypertensive Agents
Angiotensin II Type 1 Receptor Blockers
Angiotensin Receptor Antagonists
Molecular Mechanisms of Pharmacological Action
Hypoglycemic Agents
Physiological Effects of Drugs