NCT03504735

Caduet and TLC Intervention in Metabolic Syndrome

Effect of Caduet and TLC Intervention on Metabolic Parameters

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 53 (actual)
• Sponsor: The University of Texas Medical Branch, Galveston · Academic / Other
• Sex: All
• Age: 40 Years – 60 Years
• Healthy volunteers: Not accepted

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.

Conditions

• Metabolic Syndrome

Interventions

Type	Name	Description
BEHAVIORAL	Therapeutic Lifestyle Change	Monthly consult with a dietitian and fitness instructor.
DRUG	Caduet Pill	Take once daily.
DRUG	Placebo	Take once daily.

Timeline

• Start date: 2005-05-01
• Primary completion: 2009-01-01
• Completion: 2016-02-28
• First posted: 2018-04-20
• Last updated: 2018-06-13