Caduet and TLC Intervention in Metabolic Syndrome

Study Overview
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Brief Summary
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To evaluate the effectiveness of Caduet in addition to therapeutic life-style change (TLC) intervention in resolving metabolic syndrome fifty three individuals were randomized to TLC intervention study with or without Caduet therapy for 12 months. The participants underwent monthly visits with investigators to obtain vital signs, and to undergo TLC counseling. Metabolic parameters were measured before and after intervention.

Detailed Description
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Single center, investigator driven, double blinded, randomized with Caduet 5/10mg vs placebo. The participants visited with investigators on a monthly bases to evaluate the BP, weight, and obtain the waist measurements, and counseling. OGTT was performed at the beginning and the end of the study. Lipid and glucose parameters were measured 5 times in duration of the study period. Exercise physiologists and dietitians completed the baseline evaluations and provided recommendations throughout the study period in person, via phone or e-mail: per subject preference. VO2 max was measured at the beginning and end of the study. Pedometers dispensed to encourage physical activity.

Official Title
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Effect of Caduet and TLC Intervention on Metabolic Parameters

Conditions
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Metabolic Syndrome

Intervention / Treatment
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* Behavioral: Therapeutic Lifestyle Change
* Drug: Caduet Pill
* Drug: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: BP ≥130/85 Metabolic syndrome per NCEP-ATP III revised (3/5 criteria) Men and women age 40-65 Exclusion Criteria: Inability to sign a consent form. Unwillingness to complete the protocol for the duration of 15 months Unwillingness of primary care physician to participate in the program Patients already on hypercholesterolemia agent Fasting plasma glucose above 126 mg/dL or current treatment for diabetes. If the physician believes the patient should be started on antihypertensive regimen. Creatinine clearance <50ml/min. Therapy with anticoagulants Pregnant/lactating women (pre-menopausal women should be on birth control pill) AST/ALT > x3 upper limit of normal Evidence of cholelithiasis Use of oral anticoagulants Cancer Recent cardiovascular event (<6months) Substance abuse Since there is no translator, non-English speaking subjects will not be enrolled in the study.

Ages Eligible for Study
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Minimum Age: 40 Years
Maximum Age: 60 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Placebo Comparator: Therapeutic Lifestyle Change+Placebo<br>Therapeutic Life-style change intervention with Placebo pills. | Behavioral: Therapeutic Lifestyle Change<br>* Monthly consult with a dietitian and fitness instructor.<br>* Other names: TLC;Drug: Placebo<br>* Take once daily.<br>* Other names: Oral Tablet;|
| Active Comparator: Therapeutic Lifestyle Change+Caduet<br>Therapeutic Lifestyle Change intervention with Caduet pills. | Behavioral: Therapeutic Lifestyle Change<br>* Monthly consult with a dietitian and fitness instructor.<br>* Other names: TLC;Drug: Caduet Pill<br>* Take once daily.<br>* Other names: 5Mg-10Mg Tablet;|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Resolution or improvement of metabolic syndrome. | HDL >40mg/dl for men, >50 mg/dl for women. Glucose <100mg/dl Waist circumference <40 in in men, <35 in in women Triglycerides <150mg/dl BP <130/80 Attainment of 1 or more of these goals will result in resolution or improvement of metabolic syndrome | 12 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Weight loss | 5% decrease compared to that at the start of the study. | 12 months |