search
Back to results

Caduet and TLC Intervention in Metabolic Syndrome

Primary Purpose

Metabolic Syndrome

Status
Completed
Phase
Phase 4
Locations
Study Type
Interventional
Intervention
Therapeutic Lifestyle Change
Caduet Pill
Placebo
Sponsored by
The University of Texas Medical Branch, Galveston
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Metabolic Syndrome

Eligibility Criteria

40 Years - 60 Years (Adult)All SexesDoes not accept 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.

Sites / Locations

    Arms of the Study

    Arm 1

    Arm 2

    Arm Type

    Placebo Comparator

    Active Comparator

    Arm Label

    Therapeutic Lifestyle Change+Placebo

    Therapeutic Lifestyle Change+Caduet

    Arm Description

    Therapeutic Life-style change intervention with Placebo pills.

    Therapeutic Lifestyle Change intervention with Caduet pills.

    Outcomes

    Primary Outcome Measures

    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

    Secondary Outcome Measures

    Weight loss
    5% decrease compared to that at the start of the study.

    Full Information

    First Posted
    March 15, 2018
    Last Updated
    June 11, 2018
    Sponsor
    The University of Texas Medical Branch, Galveston
    Collaborators
    Pfizer, University of Texas Southwestern Medical Center
    search

    1. Study Identification

    Unique Protocol Identification Number
    NCT03504735
    Brief Title
    Caduet and TLC Intervention in Metabolic Syndrome
    Official Title
    Effect of Caduet and TLC Intervention on Metabolic Parameters
    Study Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2018
    Overall Recruitment Status
    Completed
    Study Start Date
    May 1, 2005 (Actual)
    Primary Completion Date
    January 1, 2009 (Actual)
    Study Completion Date
    February 28, 2016 (Actual)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor
    Name of the Sponsor
    The University of Texas Medical Branch, Galveston
    Collaborators
    Pfizer, University of Texas Southwestern Medical Center

    4. Oversight

    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
    Data Monitoring Committee
    No

    5. Study Description

    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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Metabolic Syndrome

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Phase 4
    Interventional Study Model
    Parallel Assignment
    Masking
    ParticipantCare ProviderInvestigator
    Allocation
    Randomized
    Enrollment
    53 (Actual)

    8. Arms, Groups, and Interventions

    Arm Title
    Therapeutic Lifestyle Change+Placebo
    Arm Type
    Placebo Comparator
    Arm Description
    Therapeutic Life-style change intervention with Placebo pills.
    Arm Title
    Therapeutic Lifestyle Change+Caduet
    Arm Type
    Active Comparator
    Arm Description
    Therapeutic Lifestyle Change intervention with Caduet pills.
    Intervention Type
    Behavioral
    Intervention Name(s)
    Therapeutic Lifestyle Change
    Other Intervention Name(s)
    TLC
    Intervention Description
    Monthly consult with a dietitian and fitness instructor.
    Intervention Type
    Drug
    Intervention Name(s)
    Caduet Pill
    Other Intervention Name(s)
    5Mg-10Mg Tablet
    Intervention Description
    Take once daily.
    Intervention Type
    Drug
    Intervention Name(s)
    Placebo
    Other Intervention Name(s)
    Oral Tablet
    Intervention Description
    Take once daily.
    Primary Outcome Measure Information:
    Title
    Resolution or improvement of metabolic syndrome.
    Description
    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
    Time Frame
    12 months
    Secondary Outcome Measure Information:
    Title
    Weight loss
    Description
    5% decrease compared to that at the start of the study.
    Time Frame
    12 months

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    40 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    Eligibility 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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Nicola Abate, MD
    Organizational Affiliation
    University of Texas
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Plan to Share IPD
    No

    Learn more about this trial

    Caduet and TLC Intervention in Metabolic Syndrome

    We'll reach out to this number within 24 hrs