Caduet and TLC Intervention in Metabolic Syndrome

Phase 4

Completed

• Conditions: Metabolic Syndrome
• Interventions: Behavioral: Therapeutic Lifestyle Change; Drug: Placebo; Drug: Caduet Pill

• Registration Number: NCT03504735
• Lead Sponsor: The University of Texas Medical Branch, Galveston

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2005-05-01
• Primary Completion: 2009-01-01
• Study Completion: 2016-02-28
• Study First Submitted: 2018-03-15
• Status Verified: 2018-04
• Study First Submitted QC: 2018-04-19
• Study First Posted: 2018-04-20
• Last Update Submitted: 2018-06-11
• Last Update Posted: 2018-06-13

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 53

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.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Therapeutic Lifestyle Change+Placebo	Therapeutic Lifestyle Change	Therapeutic Life-style change intervention with Placebo pills.
Therapeutic Lifestyle Change+Placebo	Placebo	Therapeutic Life-style change intervention with Placebo pills.
Therapeutic Lifestyle Change+Caduet	Therapeutic Lifestyle Change	Therapeutic Lifestyle Change intervention with Caduet pills.
Therapeutic Lifestyle Change+Caduet	Caduet Pill	Therapeutic Lifestyle Change intervention with Caduet pills.

Primary Outcome Measures

Name	Time	Method
Resolution or improvement of metabolic syndrome.	12 months	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

Secondary Outcome Measures

Name	Time	Method
Weight loss	12 months	5% decrease compared to that at the start of the study.