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

NCT ID: NCT01785615

Last Updated: 2017-06-07

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE1/PHASE2
• Total Enrollment: 116 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2004-11-30
• Study Completion Date: 2013-05-31

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.

Conditions

Metabolic Syndrome

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Atorvastatin

44 women randomized to 80 mg atorvastatin for 6weeks

Group Type: EXPERIMENTAL

Atorvastatin

Intervention Type: DRUG

80mg

sugar pill

44 women randomized to placebo for 6 weeks

Group Type: PLACEBO_COMPARATOR

Placebo

Intervention Type: OTHER

80mg

Interventions

Atorvastatin

80mg

Intervention Type: DRUG

Placebo

80mg

Intervention Type: OTHER

Other Intervention Names

Lipitor

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

Pfizer

INDUSTRY

Sponsor Role: collaborator

University of Rochester

OTHER

Sponsor Role: lead

Responsible Party

Gladys Velarde

Principle Investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Gladys P Velarde, MD

Role: PRINCIPAL_INVESTIGATOR

University of Rochester

Locations

University of Rochester Medical Center

Rochester, New York, United States

Countries

United States

References

Velarde GP, Choudhary N, Bravo-Jaimes K, Smotherman C, Sherazi S, Kraemer DF. Effect of atorvastatin on lipogenic, inflammatory and thrombogenic markers in women with the metabolic syndrome. Nutr Metab Cardiovasc Dis. 2021 Feb 8;31(2):634-640. doi: 10.1016/j.numecd.2020.10.002. Epub 2020 Oct 10.

Reference Type: DERIVED

PMID: 33485731 (View on PubMed)

Other Identifiers

Grant# 2004-1035

Identifier Type: OTHER_GRANT

Identifier Source: secondary_id

Protocol No. 1988

Identifier Type: -

Identifier Source: org_study_id