Caduet and TLC Intervention in Metabolic Syndrome

The University of Texas System (UT)

Status and phase: Completed; Phase 4

Conditions: Metabolic Syndrome

Treatments: Behavioral: Therapeutic Lifestyle Change; Drug: Placebo; Drug: Caduet Pill

Study type: Interventional

Funder types: Other; Industry

Identifiers

NCT03504735

082005-005

Details and patient eligibility

About

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.

Full description

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.

Enrollment: 53 patients

Sex: All

Ages: 40 to 60 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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53 participants in 2 patient groups, including a placebo group

Therapeutic Lifestyle Change+Placebo

Placebo Comparator group

Description:

Therapeutic Life-style change intervention with Placebo pills.

Treatment:

Drug: Placebo

Behavioral: Therapeutic Lifestyle Change

Therapeutic Lifestyle Change+Caduet

Active Comparator group

Description:

Therapeutic Lifestyle Change intervention with Caduet pills.

Treatment:

Drug: Caduet Pill

Behavioral: Therapeutic Lifestyle Change