Caduet and TLC Intervention in Metabolic Syndrome

Metabolic Syndrome Clinical Trial

Official title:

Effect of Caduet and TLC Intervention on Metabolic Parameters

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT03504735
• Other study ID #: 082005-005
• Status: Completed
• Phase: Phase 4
• Start date: May 1, 2005
• Est. completion date: February 28, 2016

Study information

• Verified date: April 2018
• Source: The University of Texas Medical Branch, Galveston
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 53
• Est. completion date: February 28, 2016
• Est. primary completion date: January 1, 2009
• Accepts healthy volunteers: No
• Gender: All
• Age group: 40 Years to 60 Years

Eligibility

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.

Related Conditions & MeSH terms

• Metabolic Syndrome
• Metabolic Syndrome X
• Syndrome

Intervention

Behavioral:
• Therapeutic Lifestyle Change
Monthly consult with a dietitian and fitness instructor.

Drug:
• Caduet Pill
Take once daily.
• Placebo
Take once daily.

Locations

Country	Name	City	State
n/a

Sponsors (3)

Lead Sponsor	Collaborator
The University of Texas Medical Branch, Galveston	Pfizer, University of Texas Southwestern Medical Center

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	Weight loss	5% decrease compared to that at the start of the study.	12 months