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Caduet and TLC Intervention in Metabolic Syndrome

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ClinicalTrials.gov Identifier: NCT03504735
Recruitment Status : Completed
First Posted : April 20, 2018
Last Update Posted : June 13, 2018
Sponsor:
Collaborators:
Pfizer
University of Texas Southwestern Medical Center
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Metabolic Syndrome Behavioral: Therapeutic Lifestyle Change Drug: Caduet Pill Drug: Placebo Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 53 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: Effect of Caduet and TLC Intervention on Metabolic Parameters
Actual Study Start Date : May 1, 2005
Actual Primary Completion Date : January 1, 2009
Actual Study Completion Date : February 28, 2016

Resource links provided by the National Library of Medicine

Drug Information available for: Caduet

Arm Intervention/treatment
Placebo Comparator: Therapeutic Lifestyle Change+Placebo
Therapeutic Life-style change intervention with Placebo pills.
Behavioral: Therapeutic Lifestyle Change
Monthly consult with a dietitian and fitness instructor.
Other Name: TLC

Drug: Placebo
Take once daily.
Other Name: Oral Tablet

Active Comparator: Therapeutic Lifestyle Change+Caduet
Therapeutic Lifestyle Change intervention with Caduet pills.
Behavioral: Therapeutic Lifestyle Change
Monthly consult with a dietitian and fitness instructor.
Other Name: TLC

Drug: Caduet Pill
Take once daily.
Other Name: 5Mg-10Mg Tablet




Primary Outcome Measures :
  1. 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


Secondary Outcome Measures :
  1. Weight loss [ Time Frame: 12 months ]
    5% decrease compared to that at the start of the study.



Information from the National Library of Medicine

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Ages Eligible for Study:   40 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03504735


Sponsors and Collaborators
The University of Texas Medical Branch, Galveston
Pfizer
University of Texas Southwestern Medical Center
Investigators
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Principal Investigator: Nicola Abate, MD University of Texas

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Responsible Party: The University of Texas Medical Branch, Galveston
ClinicalTrials.gov Identifier: NCT03504735     History of Changes
Other Study ID Numbers: 082005-005
First Posted: April 20, 2018    Key Record Dates
Last Update Posted: June 13, 2018
Last Verified: April 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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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

Additional relevant MeSH terms:
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Metabolic Syndrome
Syndrome
Disease
Pathologic Processes
Insulin Resistance
Hyperinsulinism
Glucose Metabolism Disorders
Metabolic Diseases
Amlodipine, atorvastatin drug combination
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Lipid Regulating Agents
Antihypertensive Agents
Calcium Channel Blockers
Membrane Transport Modulators
Calcium-Regulating Hormones and Agents
Physiological Effects of Drugs
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Enzyme Inhibitors