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
About this trial
This is an interventional treatment trial for Metabolic Syndrome
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.
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
NCT ID
NCT03504735
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
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
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Caduet and TLC Intervention in Metabolic Syndrome
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