Caduet and TLC Intervention in Metabolic Syndrome
Effect of Caduet and TLC Intervention on Metabolic Parameters
1 other identifier
interventional
53
0 countries
N/A
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_4
Started May 2005
Longer than P75 for phase_4
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
May 1, 2005
CompletedPrimary Completion
Last participant's last visit for primary outcome
January 1, 2009
CompletedStudy Completion
Last participant's last visit for all outcomes
February 28, 2016
CompletedFirst Submitted
Initial submission to the registry
March 15, 2018
CompletedFirst Posted
Study publicly available on registry
April 20, 2018
CompletedJune 13, 2018
April 1, 2018
3.7 years
March 15, 2018
June 11, 2018
Conditions
Outcome Measures
Primary Outcomes (1)
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
12 months
Secondary Outcomes (1)
Weight loss
12 months
Study Arms (2)
Therapeutic Lifestyle Change+Placebo
PLACEBO COMPARATORTherapeutic Life-style change intervention with Placebo pills.
Therapeutic Lifestyle Change+Caduet
ACTIVE COMPARATORTherapeutic Lifestyle Change intervention with Caduet pills.
Interventions
Monthly consult with a dietitian and fitness instructor.
Eligibility Criteria
You may qualify if:
- BP ≥130/85
- Metabolic syndrome per NCEP-ATP III revised (3/5 criteria)
- Men and women age 40-65
You may not qualify if:
- 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
- +1 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- The University of Texas Medical Branch, Galvestonlead
- Pfizercollaborator
- University of Texas Southwestern Medical Centercollaborator
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Nicola Abate, MD
University of Texas
Study Design
- Study Type
- interventional
- Phase
- phase 4
- Allocation
- RANDOMIZED
- Masking
- TRIPLE
- Who Masked
- PARTICIPANT, CARE PROVIDER, INVESTIGATOR
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
March 15, 2018
First Posted
April 20, 2018
Study Start
May 1, 2005
Primary Completion
January 1, 2009
Study Completion
February 28, 2016
Last Updated
June 13, 2018
Record last verified: 2018-04
Data Sharing
- IPD Sharing
- Will not share