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NCT Number: NCT00170937

A 16 Week Study to Evaluate the Effect on Insulin Sensitivity of Valsartan (320 mg) and Hydrochlorothiazide (25 mg) Combined and Alone, in Patients With Metabolic Syndrome

The metabolic syndrome is a classification for patients with a constellation of risk factors which may include abdominal obesity, hypertension, elevated blood lipids and sugar. Three or more of these factors together constitute the metabolic syndrome and place these patients at a greater risk for the development of diabetes and cardiovascular diseases. The purpose of this study is to determine whether two common drugs to lower blood pressure, whether used separately or in combination, have different effects on blood sugar levels in patients diagnosed with the metabolic syndrome.

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Key information

Conditions

Metabolic Syndrome Cardiovascular Diseases Glucose Metabolism Disorders Hyperinsulinism Hypertension Insulin Resistance Metabolic Diseases Nutritional and Metabolic Diseases Pre-Hypertension Prehypertension Vascular Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Novartis Pharmaceuticals

East Hanover, New Jersey, 07936, United States

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • Waist circumference: males > 40", females > 35 "
  • MSSBP ≥ 130 mmHg but ≤ 160 mmHg and a MSDBP ≥ 85 mmHg but ≤ 100 mmHg
  • At least one of the following criteria: - Fasting plasma glucose between 5.9 and 6.9 mmol/L; - Serum triglycerides > 150 mg/dL; - LDL Cholesterol: - < 40 mg/dL males; - < 50 mg/dL females

Exclusion criteria

  • MSSBP> 180 mmHg or MSDBP > 110 mmHg
  • Inability to discontinue all prior antihypertensives for a period of 4 weeks.
  • History of diabetes
  • History of stroke, transient ischemic attack or myocardial infarction.
  • Significant weight change > 10 lbs during screening period
  • Patients taking a diuretic for 3 months prior to screening.

Other protocol-defined exclusion criteria may apply.

Treatment and study plan

valsartan plus hydrochlorothiazide

Drug

Primary outcomes

  1. Change from baseline in insulin sensitivity after 16 weeks

Secondary outcomes

  1. Change from baseline in markers of inflammation and thrombosis after 16 weeks

  2. Change from baseline in fasting plasma glucose and fasting insulin after 16 weeks

  3. Change from baseline in lipid profile after 16 weeks

  4. Change from baseline in a measurement of beta cell function after 16 weeks

  5. Adverse events, serious adverse events, laboratory values, physical examinations, and vital signs for up to 16 weeks

Sponsors and collaborators

Lead sponsor

Novartis

Industry

Registry information

Official study title

A 16 Week Study to Evaluate the Effect on Insulin Sensitivity of Valsartan and Hydrochlorothiazide Combined and Alone, in Patients With Metabolic Syndrome

Important dates

Study start
2004
Primary completion
2006
First posted
Sep 15, 2005
Registry last updated
Nov 18, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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