Caduet and TLC Intervention in Metabolic Syndrome

• Status: Completed
• Trial end date: 2016-02-28
• Target enrollment: 0
• Participant gender: All

Summary

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.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: The University of Texas Medical Branch, Galveston
• Collaborators: Pfizer; University of Texas Southwestern Medical Center
• Treatments: Amlodipine, atorvastatin drug combination

Criteria

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.