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| Name | Class |
|---|---|
| Pfizer | INDUSTRY |
| University of Texas Southwestern Medical Center | OTHER |
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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.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Therapeutic Lifestyle Change+Placebo | Placebo Comparator | Therapeutic Life-style change intervention with Placebo pills. |
|
| Therapeutic Lifestyle Change+Caduet | Active Comparator | Therapeutic Lifestyle Change intervention with Caduet pills. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Therapeutic Lifestyle Change | Behavioral | Monthly consult with a dietitian and fitness instructor. |
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| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Weight loss | 5% decrease compared to that at the start of the study. | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Nicola Abate, MD | University of Texas | Principal Investigator |
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| ID | Term |
|---|---|
| D024821 | Metabolic Syndrome |
| ID | Term |
|---|---|
| D007333 | Insulin Resistance |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
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| ID | Term |
|---|---|
| C487936 | amlodipine, atorvastatin drug combination |
| D013607 | Tablets |
| ID | Term |
|---|---|
| D004304 | Dosage Forms |
| D004364 | Pharmaceutical Preparations |
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| Caduet Pill | Drug | Take once daily. |
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| Placebo | Drug | Take once daily. |
|
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| D009750 |
| Nutritional and Metabolic Diseases |