Caduet and TLC Intervention in Metabolic Syndrome

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

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.

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.

Study Design

• 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

Arms and Interventions

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

Outcome Measures

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.

Eligibility Criteria

• 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.

Contacts and Locations

Sponsors and Collaborators

The University of Texas Medical Branch, Galveston

Pfizer

University of Texas Southwestern Medical Center

Investigators

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

More Information

• Responsible Party: The University of Texas Medical Branch, Galveston
• ClinicalTrials.gov Identifier: NCT03504735
• Other Study ID Numbers: 082005-005
• First Posted: April 20, 2018
• Last Update Posted: June 13, 2018
• Last Verified: April 2018

Individual Participant Data (IPD) Sharing Statement:

• Plan to Share IPD: No

• 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:

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