Prothrombotic Inflammatory Markers in Women With Metabolic Syndrome - Effect of Atorvastatin (PINK)
25. april 2017 oppdatert av: 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.
Studieoversikt
Status
Fullført
Forhold
Intervensjon / Behandling
Detaljert 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.
Studietype
Intervensjonell
Registrering (Faktiske)
116
Fase
- Fase 2
- Fase 1
Kontakter og plasseringer
Denne delen inneholder kontaktinformasjon for de som utfører studien, og informasjon om hvor denne studien blir utført.
Studiesteder
-
-
New York
-
Rochester, New York, Forente stater, 14642
- University of Rochester Medical Center
-
-
Deltakelseskriterier
Forskere ser etter personer som passer til en bestemt beskrivelse, kalt kvalifikasjonskriterier. Noen eksempler på disse kriteriene er en persons generelle helsetilstand eller tidligere behandlinger.
Kvalifikasjonskriterier
Alder som er kvalifisert for studier
18 år til 75 år (Voksen, Eldre voksen)
Tar imot friske frivillige
Ja
Kjønn som er kvalifisert for studier
Hunn
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
Denne delen gir detaljer om studieplanen, inkludert hvordan studien er utformet og hva studien måler.
Hvordan er studiet utformet?
Designdetaljer
- Primært formål: Behandling
- Tildeling: Randomisert
- Intervensjonsmodell: Parallell tildeling
- Masking: Dobbelt
Våpen og intervensjoner
Deltakergruppe / Arm |
Intervensjon / Behandling |
|---|---|
|
Eksperimentell: Atorvastatin
44 women randomized to 80 mg atorvastatin for 6weeks
|
80 mg
Andre navn:
|
|
Placebo komparator: sugar pill
44 women randomized to placebo for 6 weeks
|
80mg
|
Hva måler studien?
Primære resultatmål
Resultatmål |
Tiltaksbeskrivelse |
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 |
Tiltaksbeskrivelse |
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
|
Samarbeidspartnere og etterforskere
Det er her du vil finne personer og organisasjoner som er involvert i denne studien.
Sponsor
Samarbeidspartnere
Etterforskere
- Hovedetterforsker: Gladys P Velarde, MD, University of Rochester
Publikasjoner og nyttige lenker
Den som er ansvarlig for å legge inn informasjon om studien leverer frivillig disse publikasjonene. Disse kan handle om alt relatert til studiet.
Studierekorddatoer
Disse datoene sporer fremdriften for innsending av studieposter og sammendragsresultater til ClinicalTrials.gov. Studieposter og rapporterte resultater gjennomgås av National Library of Medicine (NLM) for å sikre at de oppfyller spesifikke kvalitetskontrollstandarder før de legges ut på det offentlige nettstedet.
Studer hoveddatoer
Studiestart
1. november 2004
Primær fullføring (Faktiske)
1. desember 2011
Studiet fullført (Faktiske)
1. mai 2013
Datoer for studieregistrering
Først innsendt
1. februar 2013
Først innsendt som oppfylte QC-kriteriene
4. februar 2013
Først lagt ut (Anslag)
7. februar 2013
Oppdateringer av studieposter
Sist oppdatering lagt ut (Faktiske)
7. juni 2017
Siste oppdatering sendt inn som oppfylte QC-kriteriene
25. april 2017
Sist bekreftet
1. april 2017
Mer informasjon
Begreper knyttet til denne studien
Nøkkelord
Ytterligere relevante MeSH-vilkår
- Patologiske prosesser
- Glukosemetabolismeforstyrrelser
- Metabolske sykdommer
- Sykdom
- Insulinresistens
- Hyperinsulinisme
- Syndrom
- Metabolsk syndrom
- Molekylære mekanismer for farmakologisk virkning
- Enzymhemmere
- Antimetabolitter
- Antikolesteremiske midler
- Hypolipidemiske midler
- Lipidregulerende midler
- Hydroksymetylglutaryl-CoA-reduktasehemmere
- Atorvastatin
Andre studie-ID-numre
- Protocol No. 1988
- Grant# 2004-1035 (Annet stipend/finansieringsnummer: RSRB 29937)
Denne informasjonen ble hentet direkte fra nettstedet clinicaltrials.gov uten noen endringer. Hvis du har noen forespørsler om å endre, fjerne eller oppdatere studiedetaljene dine, vennligst kontakt register@clinicaltrials.gov. Så snart en endring er implementert på clinicaltrials.gov, vil denne også bli oppdatert automatisk på nettstedet vårt. .