Prothrombotic Inflammatory Markers in Women With Metabolic Syndrome - Effect of Atorvastatin

NCT01785615

Last updated date
Study Location
University of Rochester Medical Center
Rochester, New York, 14642, United States
Contact
1-800-718-1021

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Eligibility Criteria
condition
The disease, disorder, syndrome, illness, or injury that is being studied.
Metabolic Syndrome
Sex
Female
Age
Pediatric Trials: 0-17 Years
Adult Trials: 18+ Years
18-75 years
Inclusion Criteria
The factors, or reasons, that allow a person to participate in a clinical study.
Show details

- Women between the ages of 18-75 with Metabolic syndrome

- Abdominal circumference > 35 in

- Hypertriglyceridemia > 150mg/dl

- HDL <50

- Blood Pressure >130/85

- Fasting Glucose >100

Exclusion Criteria
The factors, or reasons, that prevent a person from participating in a clinical study.
Show details


- Pregnant or planning to become pregnant in the next 6-12 months


- Receiving lipid-lowing drugs


- Obstructive hepatobiliary disease or serious hepatic disease


- Diabetes, cardiovascular disease (CVD), hypothyroidism, active infection, cancer,
recent surgery


- Fulfill criteria to receive statin based on LDL levels, risk factors, and Framingham
risk scoring outlined on ATP111/NCEP 111 recommendations


- Documented allergic reaction to statin in past


- unexplained elevation in creatinine kinase levels > 3 times upper limit

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Advanced Information
Descriptive Information
Brief Title  ICMJE Prothrombotic Inflammatory Markers in Women With Metabolic Syndrome - Effect of Atorvastatin
Official Title  ICMJE Interactions of Thrombogenic, Lipogenic, and Inflammatory Markers in Women With the Metabolic Syndrome - Effect of Atorvastatin
Brief Summary

Little is known regarding the association of individual components of the metabolic syndrome (MBS) and prothrombotic, inflammatory and preclinical cardiac structural and functional markers in women with this syndrome. Less is known about adequate treatment as the pathological mechanism of this syndrome is not well understood.

The purpose of this study is two fold;

  1. To determine basic differences in biochemical and cardiovascular structural markers in women with and those without MBS and their association with the individual components of MBS.
  2. To determine the impact of atorvastatin to lower the risk factors of Metabolic Syndrome. Atorvastatin is one of the most effective drugs approved by the United States Food and Drug Administration (FDA) for the treatment of high cholesterol. It belongs to a class of drugs called statins and its role in primary prevention is still unclear. Thus this population seems to be an ideal group that may benefit from this intervention.
Detailed Description The first phase of the study is an observational phase as previously described. The second phase was a prospective evaluation of the effect of a well known "statin" drug (Lipitor) on different biochemical factors measured in the blood. The eligible study participants had blood work done upon enrollment and if criteria was met(according to the Adult Treatment Panel III), they were given dietary counseling (NYHA - New York Heart Association Step 1 diet) as a lead in phase. Lab work was repeated at 3 weeks to evaluate the impact of the diet and if participant's profile still met criteria for MBS,randomization for either atorvastatin (Lipitor) 80mg or placebo (sugar pill) for 12 weeks took place.
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 1
Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Condition  ICMJE Metabolic Syndrome
Intervention  ICMJE
  • Drug: Atorvastatin
    80mg
    Other Name: Lipitor
  • Other: Placebo
    80mg
Study Arms  ICMJE
  • Experimental: Atorvastatin
    44 women randomized to 80 mg atorvastatin for 6weeks
    Intervention: Drug: Atorvastatin
  • Placebo Comparator: sugar pill
    44 women randomized to placebo for 6 weeks
    Intervention: Other: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: April 25, 2017)
116
Original Estimated Enrollment  ICMJE
 (submitted: February 4, 2013)
88
Actual Study Completion Date  ICMJE May 2013
Actual Primary Completion Date December 2011   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

Inclusion Criteria:

  • Women between the ages of 18-75 with Metabolic syndrome
  • Abdominal circumference > 35 in
  • Hypertriglyceridemia > 150mg/dl
  • HDL <50
  • Blood Pressure >130/85
  • Fasting Glucose >100

Exclusion Criteria:

  • Pregnant or planning to become pregnant in the next 6-12 months
  • Receiving lipid-lowing drugs
  • Obstructive hepatobiliary disease or serious hepatic disease
  • Diabetes, cardiovascular disease (CVD), hypothyroidism, active infection, cancer, recent surgery
  • Fulfill criteria to receive statin based on LDL levels, risk factors, and Framingham risk scoring outlined on ATP111/NCEP 111 recommendations
  • Documented allergic reaction to statin in past
  • unexplained elevation in creatinine kinase levels > 3 times upper limit
Sex/Gender  ICMJE
Sexes Eligible for Study:Female
Ages  ICMJE 18 Years to 75 Years   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE Yes
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT01785615
Other Study ID Numbers  ICMJE Protocol No. 1988
Grant# 2004-1035 ( Other Grant/Funding Number: RSRB 29937 )
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Gladys Velarde, University of Rochester
Study Sponsor  ICMJE University of Rochester
Collaborators  ICMJE Pfizer
Investigators  ICMJE
Principal Investigator:Gladys P Velarde, MDUniversity of Rochester
PRS Account University of Rochester
Verification Date April 2017

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP