Prothrombotic Inflammatory Markers in Women With Metabolic Syndrome - Effect of Atorvastatin (PINK)
25. april 2017 opdateret af: Gladys Velarde, University of Rochester
Interactions of Thrombogenic, Lipogenic, and Inflammatory Markers in Women With the Metabolic Syndrome - Effect of Atorvastatin
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;
- 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.
- 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.
Studieoversigt
Status
Afsluttet
Betingelser
Intervention / Behandling
Detaljeret beskrivelse
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.
Undersøgelsestype
Interventionel
Tilmelding (Faktiske)
116
Fase
- Fase 2
- Fase 1
Kontakter og lokationer
Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.
Studiesteder
-
-
New York
-
Rochester, New York, Forenede Stater, 14642
- University of Rochester Medical Center
-
-
Deltagelseskriterier
Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.
Berettigelseskriterier
Aldre berettiget til at studere
18 år til 75 år (Voksen, Ældre voksen)
Tager imod sunde frivillige
Ja
Køn, der er berettiget til at studere
Kvinde
Beskrivelse
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
Studieplan
Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.
Hvordan er undersøgelsen tilrettelagt?
Design detaljer
- Primært formål: Behandling
- Tildeling: Randomiseret
- Interventionel model: Parallel tildeling
- Maskning: Dobbelt
Våben og indgreb
Deltagergruppe / Arm |
Intervention / Behandling |
|---|---|
|
Eksperimentel: Atorvastatin
44 women randomized to 80 mg atorvastatin for 6weeks
|
80 mg
Andre navne:
|
|
Placebo komparator: sugar pill
44 women randomized to placebo for 6 weeks
|
80mg
|
Hvad måler undersøgelsen?
Primære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Mean Low Density Lipoprotein Cholesterol in Blood
Tidsramme: 6 weeks
|
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
Tidsramme: 6 weeks
|
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
Tidsramme: 6 weeks
|
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
Tidsramme: 6 weeks
|
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
Tidsramme: 6 weeks
|
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
Tidsramme: 6 weeks
|
Waist circumference was measured with a ruler tape.
|
6 weeks
|
|
Mean Systolic Blood Pressure
Tidsramme: 6 weeks
|
Measured with a blood pressure cuff
|
6 weeks
|
|
Mean Diastolic Blood Pressure
Tidsramme: 6 weeks
|
Measured with a blood pressure cuff
|
6 weeks
|
|
Mean High Density Lipoprotein Cholesterol in Blood
Tidsramme: 6 weeks
|
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
Tidsramme: 6 weeks
|
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
Tidsramme: 6 weeks
|
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
Tidsramme: 6 weeks
|
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
Tidsramme: 6 weeks
|
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
Tidsramme: 6 weeks
|
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
Tidsramme: 6 weeks
|
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
Tidsramme: 6 weeks
|
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
Tidsramme: 6 weeks
|
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
|
Sekundære resultatmål
Resultatmål |
Foranstaltningsbeskrivelse |
Tidsramme |
|---|---|---|
|
Mean Waist Circumference
Tidsramme: week 0
|
Waist circumference was measured with a ruler tape.
|
week 0
|
|
Mean Low Density Lipoprotein Cholesterol in Blood
Tidsramme: 0 weeks
|
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.
|
0 weeks
|
|
Mean Triglycerides in Blood
Tidsramme: 0 weeks
|
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.
|
0 weeks
|
|
Mean Myeloperoxidase in Blood
Tidsramme: 0 weeks
|
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.
|
0 weeks
|
|
Mean Fasting Blood Glucose in Blood
Tidsramme: 0 weeks
|
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.
|
0 weeks
|
|
Mean High Density Lipoprotein Cholesterol in Blood
Tidsramme: 0 weeks
|
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.
|
0 weeks
|
|
Mean Intercellular Adhesion Molecule in Blood
Tidsramme: 0 weeks
|
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.
|
0 weeks
|
|
Mean Systolic Blood Pressure
Tidsramme: 0 weeks
|
Measured with a blood pressure cuff
|
0 weeks
|
|
Mean Diastolic Blood Pressure
Tidsramme: 0 weeks
|
Measured with a blood pressure cuff
|
0 weeks
|
|
Mean Vascular Adhesion Molecule in Blood
Tidsramme: 0 weeks
|
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.
|
0 weeks
|
|
Mean Apolipoprotein A-1 in Blood
Tidsramme: 0 weeks
|
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.
|
0 weeks
|
|
Mean Apolipoprotein B in Blood
Tidsramme: 0 weeks
|
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.
|
0 weeks
|
|
Mean Apolipoprotein B/ Apolipoprotein A1 Ratio in Blood
Tidsramme: 0 weeks
|
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.
|
0 weeks
|
|
Mean Hs-C Reactive Protein in Blood
Tidsramme: 0 weeks
|
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.
|
0 weeks
|
|
Mean Leptin in Blood
Tidsramme: 0 weeks
|
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.
|
0 weeks
|
|
Mean Plasminogen Activator Inhibitor-1 in Blood
Tidsramme: 0 weeks
|
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.
|
0 weeks
|
Samarbejdspartnere og efterforskere
Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.
Sponsor
Samarbejdspartnere
Efterforskere
- Ledende efterforsker: Gladys P Velarde, MD, University of Rochester
Publikationer og nyttige links
Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.
Datoer for undersøgelser
Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.
Studer store datoer
Studiestart
1. november 2004
Primær færdiggørelse (Faktiske)
1. december 2011
Studieafslutning (Faktiske)
1. maj 2013
Datoer for studieregistrering
Først indsendt
1. februar 2013
Først indsendt, der opfyldte QC-kriterier
4. februar 2013
Først opslået (Skøn)
7. februar 2013
Opdateringer af undersøgelsesjournaler
Sidste opdatering sendt (Faktiske)
7. juni 2017
Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier
25. april 2017
Sidst verificeret
1. april 2017
Mere information
Begreber relateret til denne undersøgelse
Nøgleord
Yderligere relevante MeSH-vilkår
- Patologiske processer
- Glukosemetabolismeforstyrrelser
- Metaboliske sygdomme
- Sygdom
- Insulin resistens
- Hyperinsulinisme
- Syndrom
- Metabolisk syndrom
- Molekylære mekanismer for farmakologisk virkning
- Enzymhæmmere
- Antimetabolitter
- Antikolesteræmiske midler
- Hypolipidæmiske midler
- Lipidregulerende midler
- Hydroxymethylglutaryl-CoA-reduktasehæmmere
- Atorvastatin
Andre undersøgelses-id-numre
- Protocol No. 1988
- Grant# 2004-1035 (Andet bevillings-/finansieringsnummer: RSRB 29937)
Disse oplysninger blev hentet direkte fra webstedet clinicaltrials.gov uden ændringer. Hvis du har nogen anmodninger om at ændre, fjerne eller opdatere dine undersøgelsesoplysninger, bedes du kontakte register@clinicaltrials.gov. Så snart en ændring er implementeret på clinicaltrials.gov, vil denne også blive opdateret automatisk på vores hjemmeside .