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

NCT01785615 | Completed Phase 1 Results DMC

• 2 other identifiers: Protocol No. 1988Grant# 2004-1035
• Study Type: interventional
• Target: 116
• Locations: 1 country
• Sites: 1

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. 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. 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.

Conditions

Metabolic Syndrome

Keywords

metabolic syndrome; atorvastatin; women

Outcome Measures

Primary Outcomes (17)

• Mean Low Density Lipoprotein Cholesterol in Blood

  Approximately 30 ml of blood was collected in two serum (red top), four 3.2% (0.105M) sodium citrate (blue top) Vacutainer® tubes and a syringe at each visit. Collected samples were centrifuged within an hour of collection at 3000xG for 15 minutes at 20°C to obtain platelet-poor plasma and complete serum separation. Each sample was sent to the University of Rochester Clinical Laboratories for testing.

  6 weeks

• Mean Triglycerides in Blood

  Approximately 30 ml of blood was collected in two serum (red top), four 3.2% (0.105M) sodium citrate (blue top) Vacutainer® tubes and a syringe at each visit. Collected samples were centrifuged within an hour of collection at 3000xG for 15 minutes at 20°C to obtain platelet-poor plasma and complete serum separation. Each sample was sent to the University of Rochester Clinical Laboratories for testing.

  6 weeks

• Mean Apolipoprotein B in Blood

  Approximately 30 ml of blood was collected in two serum (red top), four 3.2% (0.105M) sodium citrate (blue top) Vacutainer® tubes and a syringe at each visit. Collected samples were centrifuged within an hour of collection at 3000xG for 15 minutes at 20°C to obtain platelet-poor plasma and complete serum separation. Each sample was sent to the University of Rochester Clinical Laboratories for testing.

  6 weeks

• Mean Apolipoprotein B/ Apolipoprotein A1 Ratio in Blood

  Approximately 30 ml of blood was collected in two serum (red top), four 3.2% (0.105M) sodium citrate (blue top) Vacutainer® tubes and a syringe at each visit. Collected samples were centrifuged within an hour of collection at 3000xG for 15 minutes at 20°C to obtain platelet-poor plasma and complete serum separation. Each sample was sent to the University of Rochester Clinical Laboratories for testing. The ratio of Apo B to Apo A1 ratio was calculated.

  6 weeks

• Mean High Sensitivity C-reactive Protein in Blood

  Approximately 30 ml of blood was collected in two serum (red top), four 3.2% (0.105M) sodium citrate (blue top) Vacutainer® tubes and a syringe at each visit. Collected samples were centrifuged within an hour of collection at 3000xG for 15 minutes at 20°C to obtain platelet-poor plasma and complete serum separation. Each sample was sent to the University of Rochester Clinical Laboratories for testing. The ratio of Apo B to Apo A1 ratio was calculated

  6 weeks

• Mean Waist Circumference

  Waist circumference was measured with a ruler tape.

  6 weeks

• Mean Systolic Blood Pressure

  Measured with a blood pressure cuff

  6 weeks

• Mean Diastolic Blood Pressure

  Measured with a blood pressure cuff

  6 weeks

• Mean High Density Lipoprotein Cholesterol in Blood

  Approximately 30 ml of blood was collected in two serum (red top), four 3.2% (0.105M) sodium citrate (blue top) Vacutainer® tubes and a syringe at each visit. Collected samples were centrifuged within an hour of collection at 3000xG for 15 minutes at 20°C to obtain platelet-poor plasma and complete serum separation. Each sample was sent to the University of Rochester Clinical Laboratories for testing.

  6 weeks

• Mean Fasting Plasma Glucose in Blood

  Approximately 30 ml of blood was collected in two serum (red top), four 3.2% (0.105M) sodium citrate (blue top) Vacutainer® tubes and a syringe at each visit. Collected samples were centrifuged within an hour of collection at 3000xG for 15 minutes at 20°C to obtain platelet-poor plasma and complete serum separation. Each sample was sent to the University of Rochester Clinical Laboratories for testing.

  6 weeks

• Mean Aspartate Aminotransferase in Blood

  Approximately 30 ml of blood was collected in two serum (red top), four 3.2% (0.105M) sodium citrate (blue top) Vacutainer® tubes and a syringe at each visit. Collected samples were centrifuged within an hour of collection at 3000xG for 15 minutes at 20°C to obtain platelet-poor plasma and complete serum separation. Each sample was sent to the University of Rochester Clinical Laboratories for testing.

  6 weeks

• Mean Alanine Aminotransferase in Blood

  Approximately 30 ml of blood was collected in two serum (red top), four 3.2% (0.105M) sodium citrate (blue top) Vacutainer® tubes and a syringe at each visit. Collected samples were centrifuged within an hour of collection at 3000xG for 15 minutes at 20°C to obtain platelet-poor plasma and complete serum separation. Each sample was sent to the University of Rochester Clinical Laboratories for testing.

  6 weeks

• Mean Leptin in Blood

  Approximately 30 ml of blood was collected in two serum (red top), four 3.2% (0.105M) sodium citrate (blue top) Vacutainer® tubes and a syringe at each visit. Collected samples were centrifuged within an hour of collection at 3000xG for 15 minutes at 20°C to obtain platelet-poor plasma and complete serum separation. Each sample was sent to the University of Rochester Clinical Laboratories for testing.

  6 weeks

• Mean Soluble Intercellular Adhesion Molecule in Blood

  Approximately 30 ml of blood was collected in two serum (red top), four 3.2% (0.105M) sodium citrate (blue top) Vacutainer® tubes and a syringe at each visit. Collected samples were centrifuged within an hour of collection at 3000xG for 15 minutes at 20°C to obtain platelet-poor plasma and complete serum separation. Each sample was sent to the University of Rochester Clinical Laboratories for testing.

  6 weeks

• Mean Soluble Vascular Adhesion Molecule in Blood

  Approximately 30 ml of blood was collected in two serum (red top), four 3.2% (0.105M) sodium citrate (blue top) Vacutainer® tubes and a syringe at each visit. Collected samples were centrifuged within an hour of collection at 3000xG for 15 minutes at 20°C to obtain platelet-poor plasma and complete serum separation. Each sample was sent to the University of Rochester Clinical Laboratories for testing.

  6 weeks

• Mean Plasminogen Activator Inhibitor-1 in Blood

  Approximately 30 ml of blood was collected in two serum (red top), four 3.2% (0.105M) sodium citrate (blue top) Vacutainer® tubes and a syringe at each visit. Collected samples were centrifuged within an hour of collection at 3000xG for 15 minutes at 20°C to obtain platelet-poor plasma and complete serum separation. Each sample was sent to the University of Rochester Clinical Laboratories for testing.

  6 weeks

• Mean Myeloperoxidase in Blood

  Approximately 30 ml of blood was collected in two serum (red top), four 3.2% (0.105M) sodium citrate (blue top) Vacutainer® tubes and a syringe at each visit. Collected samples were centrifuged within an hour of collection at 3000xG for 15 minutes at 20°C to obtain platelet-poor plasma and complete serum separation. Each sample was sent to the University of Rochester Clinical Laboratories for testing.

  6 weeks

Secondary Outcomes (16)

• Mean Waist Circumference

  week 0

• Mean Low Density Lipoprotein Cholesterol in Blood

  0 weeks

• Mean Triglycerides in Blood

  0 weeks

• Mean Myeloperoxidase in Blood

  0 weeks

• Mean Fasting Blood Glucose in Blood

  0 weeks

Study Arms (2)

Atorvastatin

EXPERIMENTAL

44 women randomized to 80 mg atorvastatin for 6weeks

Drug: Atorvastatin

sugar pill

PLACEBO COMPARATOR

44 women randomized to placebo for 6 weeks

Other: Placebo

Interventions

Atorvastatin DRUG

80mg

Also known as: Lipitor

Atorvastatin

Placebo OTHER

80mg

sugar pill

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Rochester: lead
• Pfizer: collaborator

Study Sites (1)

University of Rochester Medical Center

Rochester, New York, 14642, United States

Location

Related Publications (1)

• 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.

  PMID: 33485731 DERIVED

MeSH Terms

Conditions

Metabolic Syndrome

Interventions

Atorvastatin

Condition Hierarchy (Ancestors)

Insulin Resistance; Hyperinsulinism; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases

Intervention Hierarchy (Ancestors)

Pyrroles; Azoles; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Heptanoic Acids; Fatty Acids; Lipids

Results Point of Contact

• Title: Dr. Gladys Velarde
• Organization: University of Florida College of Medicine Jacksonville

Gladys.Velarde@jax.ufl.edu

(904)244-2060

Study Officials

• Gladys P Velarde, MD

  University of Rochester

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principle Investigator

Study Record Dates

• First Submitted: February 1, 2013
• First Posted: February 7, 2013
• Study Start: November 1, 2004
• Primary Completion: December 1, 2011
• Study Completion: May 1, 2013
• Last Updated: June 7, 2017
• Results First Posted: June 7, 2017

Record last verified: 2017-04

Locations

US (1)