Caduet and TLC Intervention in Metabolic Syndrome

Effect of Caduet and TLC Intervention on Metabolic Parameters

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.

Study Overview

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 Type

Interventional

Enrollment (Actual)

53

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

40 years to 60 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Triple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Placebo Comparator: Therapeutic Lifestyle Change+Placebo
Therapeutic Life-style change intervention with Placebo pills.
Monthly consult with a dietitian and fitness instructor.
Other Names:
  • TLC
Take once daily.
Other Names:
  • Oral Tablet
Active Comparator: Therapeutic Lifestyle Change+Caduet
Therapeutic Lifestyle Change intervention with Caduet pills.
Monthly consult with a dietitian and fitness instructor.
Other Names:
  • TLC
Take once daily.
Other Names:
  • 5Mg-10Mg Tablet

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Resolution or improvement of metabolic syndrome.
Time Frame: 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
12 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Investigators

  • Principal Investigator: Nicola Abate, MD, University of Texas

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

May 1, 2005

Primary Completion (Actual)

January 1, 2009

Study Completion (Actual)

February 28, 2016

Study Registration Dates

First Submitted

March 15, 2018

First Submitted That Met QC Criteria

April 19, 2018

First Posted (Actual)

April 20, 2018

Study Record Updates

Last Update Posted (Actual)

June 13, 2018

Last Update Submitted That Met QC Criteria

June 11, 2018

Last Verified

April 1, 2018

More Information

Terms related to this study

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

product manufactured in and exported from the U.S.

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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