Clinical trial NCT01785615: Prothrombotic Inflammatory Markers in Women With Metabolic Syndrome - Effect of Atorvastatin
Official title: Interactions of Thrombogenic, Lipogenic, and Inflammatory Markers in Women With the Metabolic Syndrome - Effect of Atorvastatin
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE1
PHASE2
Conditions: Metabolic Syndrome
Keywords: metabolic syndrome
atorvastatin
women
Lead sponsor: University of Rochester
Sponsor class: OTHER
Collaborators: name: Pfizer
First posted: 2013-02-07
Enrollment: 116
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: Mean Low Density Lipoprotein Cholesterol in Blood
timeFrame: 6 weeks
measure: Mean Triglycerides in Blood
timeFrame: 6 weeks
measure: Mean Apolipoprotein B in Blood
timeFrame: 6 weeks
measure: Mean Apolipoprotein B/ Apolipoprotein A1 Ratio in Blood
timeFrame: 6 weeks
measure: Mean High Sensitivity C-reactive Protein in Blood
timeFrame: 6 weeks
measure: Mean Waist Circumference
timeFrame: 6 weeks
measure: Mean Systolic Blood Pressure
timeFrame: 6 weeks
measure: Mean Diastolic Blood Pressure
timeFrame: 6 weeks
measure: Mean High Density Lipoprotein Cholesterol in Blood
timeFrame: 6 weeks
measure: Mean Fasting Plasma Glucose in Blood
timeFrame: 6 weeks
measure: Mean Aspartate Aminotransferase in Blood
timeFrame: 6 weeks
measure: Mean Alanine Aminotransferase in Blood
timeFrame: 6 weeks
measure: Mean Leptin in Blood
timeFrame: 6 weeks
measure: Mean Soluble Intercellular Adhesion Molecule in Blood
timeFrame: 6 weeks
measure: Mean Soluble Vascular Adhesion Molecule in Blood
timeFrame: 6 weeks
measure: Mean Plasminogen Activator Inhibitor-1 in Blood
timeFrame: 6 weeks
measure: Mean Myeloperoxidase in Blood
timeFrame: 6 weeks
Secondary outcomes:
measure: Mean Waist Circumference
timeFrame: week 0
measure: Mean Low Density Lipoprotein Cholesterol in Blood
timeFrame: 0 weeks
measure: Mean Triglycerides in Blood
timeFrame: 0 weeks
measure: Mean Myeloperoxidase in Blood
timeFrame: 0 weeks
measure: Mean Fasting Blood Glucose in Blood
timeFrame: 0 weeks
measure: Mean High Density Lipoprotein Cholesterol in Blood
timeFrame: 0 weeks
measure: Mean Intercellular Adhesion Molecule in Blood
timeFrame: 0 weeks
measure: Mean Systolic Blood Pressure
timeFrame: 0 weeks
measure: Mean Diastolic Blood Pressure
timeFrame: 0 weeks
measure: Mean Vascular Adhesion Molecule in Blood
timeFrame: 0 weeks
measure: Mean Apolipoprotein A-1 in Blood
timeFrame: 0 weeks
measure: Mean Apolipoprotein B in Blood
timeFrame: 0 weeks
measure: Mean Apolipoprotein B/ Apolipoprotein A1 Ratio in Blood
timeFrame: 0 weeks
measure: Mean Hs-C Reactive Protein in Blood
timeFrame: 0 weeks
measure: Mean Leptin in Blood
timeFrame: 0 weeks
measure: Mean Plasminogen Activator Inhibitor-1 in Blood
timeFrame: 0 weeks
Other outcomes:
Locations:
city: Rochester
country: United States
facility: University of Rochester Medical Center
state: New York
Study officials:
affiliation: University of Rochester
name: Gladys P Velarde, MD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.