Clinical trial 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
Official title: A 16 Week Study to Evaluate the Effect on Insulin Sensitivity of Valsartan and Hydrochlorothiazide Combined and Alone, in Patients With Metabolic Syndrome
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: METABOLIC SYNDROME
HYPERTENSION
PRE-HYPERTENSION
Keywords: METABOLIC SYNDROME, VALSARTAN, HYDROCHLOROTHIAZIDE, HYPERTENSION,
Lead sponsor: Novartis
Sponsor class: INDUSTRY
First posted: 2005-09-15
Enrollment: 507
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: PREVENTION

Brief summary: 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.


Eligibility criteria: 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.

Primary outcomes:
measure: Change from baseline in insulin sensitivity after 16 weeks
Secondary outcomes:
measure: Change from baseline in markers of inflammation and thrombosis after 16 weeks
measure: Change from baseline in fasting plasma glucose and fasting insulin after 16 weeks
measure: Change from baseline in lipid profile after 16 weeks
measure: Change from baseline in a measurement of beta cell function after 16 weeks
measure: Adverse events, serious adverse events, laboratory values, physical examinations, and vital signs for up to 16 weeks
Other outcomes:
Locations:
city: E. Hanover
country: United States
facility: Novartis Pharmaceuticals
state: New Jersey
Study officials:
affiliation: Novartis Pharmaceuticals
name: Novartis Pharmaceuticals
role: STUDY_DIRECTOR
References:
citation: Zappe DH, Sowers JR, Hsueh WA, Haffner SM, Deedwania PC, Fonseca VA, Keeling L, Sica DA. Metabolic and antihypertensive effects of combined angiotensin receptor blocker and diuretic therapy in prediabetic hypertensive patients with the cardiometabolic syndrome. J Clin Hypertens (Greenwich). 2008 Dec;10(12):894-903. doi: 10.1111/j.1751-7176.2008.00054.x.