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

This study has been completed.
Sponsor:
Collaborator:
Pfizer
Information provided by (Responsible Party):
Gladys Velarde, University of Rochester
ClinicalTrials.gov Identifier:
NCT01785615
First received: February 1, 2013
Last updated: April 25, 2017
Last verified: April 2017
Results First Received: September 3, 2013  
Study Type: Interventional
Study Design: Allocation: Randomized;   Intervention Model: Parallel Assignment;   Masking: Participant, Investigator;   Primary Purpose: Treatment
Condition: Metabolic Syndrome
Interventions: Drug: Atorvastatin
Other: Placebo

  Participant Flow
  Hide Participant Flow

Recruitment Details
Key information relevant to the recruitment process for the overall study, such as dates of the recruitment period and locations
Approximately 250 women volunteers were screened and 140 were selected to go on to the first phase of the trial. After a 6-week period of a run in diet phase, 24 did not return to start randomization. Out of 116 women, 6 failed to meet MBS criteria by one ATP III element.

Pre-Assignment Details
Significant events and approaches for the overall study following participant enrollment, but prior to group assignment
No text entered.

Reporting Groups
  Description
Atorvastatin

44 women with metabolic syndrome randomized to 80 mg atorvastatin for 6weeks

Atorvastatin : 80mg

Sugar Pill

44 women with metabolic syndrome randomized to placebo for 6 weeks

Placebo : 80mg

Healthy Women Women without metabolic syndrome
Metabolic Syndrome Women These were women who were later randomized to receive Atorvastatin or placebo during phase 2.

Participant Flow for 2 periods

Period 1:   Dietary Phase
    Atorvastatin   Sugar Pill   Healthy Women   Metabolic Syndrome Women
STARTED   0   0   35   140 
COMPLETED   0   0   35   116 
NOT COMPLETED   0   0   0   24 
Lost to Follow-up                0                0                0                24 

Period 2:   Atorvastatin Phase
    Atorvastatin   Sugar Pill   Healthy Women   Metabolic Syndrome Women
STARTED   44   44   0   0 
COMPLETED   44   44   0   0 
NOT COMPLETED   0   0   0   0 



  Baseline Characteristics
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Population Description
Explanation of how the number of participants for analysis was determined. Includes whether analysis was per protocol, intention to treat, or another method. Also provides relevant details such as imputation technique, as appropriate.
No text entered.

Reporting Groups
  Description
Atorvastatin

44 women randomized to 80 mg atorvastatin for 6weeks

Atorvastatin : 80mg

Sugar Pill

44 women randomized to placebo for 6 weeks

Placebo : 80mg

Healthy Participants No text entered.
Total Total of all reporting groups

Baseline Measures
   Atorvastatin   Sugar Pill   Healthy Participants   Total 
Overall Participants Analyzed 
[Units: Participants]
 44   44   35   123 
Age 
[Units: Years]
Mean (Standard Deviation)
 51  (9)   52  (9)   53.7  (9.0)   52.1  (9) 
Sex: Female, Male 
[Units: Participants]
Count of Participants
       
Female      44 100.0%      44 100.0%      35 100.0%      123 100.0% 
Male      0   0.0%      0   0.0%      0   0.0%      0   0.0% 
Region of Enrollment 
[Units: Participants]
       
United States   44   44   35   88 


  Outcome Measures
  Show All Outcome Measures

1.  Primary:   Mean Low Density Lipoprotein Cholesterol in Blood   [ Time Frame: 6 weeks ]

2.  Primary:   Mean Triglycerides in Blood   [ Time Frame: 6 weeks ]

3.  Primary:   Mean Apolipoprotein B in Blood   [ Time Frame: 6 weeks ]

4.  Primary:   Mean Apolipoprotein B/ Apolipoprotein A1 Ratio in Blood   [ Time Frame: 6 weeks ]

5.  Primary:   Mean High Sensitivity C-reactive Protein in Blood   [ Time Frame: 6 weeks ]

6.  Primary:   Mean Waist Circumference   [ Time Frame: 6 weeks ]

7.  Primary:   Mean Systolic Blood Pressure   [ Time Frame: 6 weeks ]

8.  Primary:   Mean Diastolic Blood Pressure   [ Time Frame: 6 weeks ]

9.  Primary:   Mean High Density Lipoprotein Cholesterol in Blood   [ Time Frame: 6 weeks ]

10.  Primary:   Mean Fasting Plasma Glucose in Blood   [ Time Frame: 6 weeks ]

11.  Primary:   Mean Aspartate Aminotransferase in Blood   [ Time Frame: 6 weeks ]

12.  Primary:   Mean Alanine Aminotransferase in Blood   [ Time Frame: 6 weeks ]

13.  Primary:   Mean Leptin in Blood   [ Time Frame: 6 weeks ]

14.  Primary:   Mean Soluble Intercellular Adhesion Molecule in Blood   [ Time Frame: 6 weeks ]

15.  Primary:   Mean Soluble Vascular Adhesion Molecule in Blood   [ Time Frame: 6 weeks ]

16.  Primary:   Mean Plasminogen Activator Inhibitor-1 in Blood   [ Time Frame: 6 weeks ]

17.  Primary:   Mean Myeloperoxidase in Blood   [ Time Frame: 6 weeks ]

18.  Secondary:   Mean Waist Circumference   [ Time Frame: week 0 ]

19.  Secondary:   Mean Low Density Lipoprotein Cholesterol in Blood   [ Time Frame: 0 weeks ]

20.  Secondary:   Mean Triglycerides in Blood   [ Time Frame: 0 weeks ]

21.  Secondary:   Mean Myeloperoxidase in Blood   [ Time Frame: 0 weeks ]

22.  Secondary:   Mean Fasting Blood Glucose in Blood   [ Time Frame: 0 weeks ]

23.  Secondary:   Mean High Density Lipoprotein Cholesterol in Blood   [ Time Frame: 0 weeks ]

24.  Secondary:   Mean Intercellular Adhesion Molecule in Blood   [ Time Frame: 0 weeks ]

25.  Secondary:   Mean Systolic Blood Pressure   [ Time Frame: 0 weeks ]

26.  Secondary:   Mean Diastolic Blood Pressure   [ Time Frame: 0 weeks ]

27.  Secondary:   Mean Vascular Adhesion Molecule in Blood   [ Time Frame: 0 weeks ]

28.  Secondary:   Mean Apolipoprotein A-1 in Blood   [ Time Frame: 0 weeks ]

29.  Secondary:   Mean Apolipoprotein B in Blood   [ Time Frame: 0 weeks ]

30.  Secondary:   Mean Apolipoprotein B/ Apolipoprotein A1 Ratio in Blood   [ Time Frame: 0 weeks ]

31.  Secondary:   Mean Hs-C Reactive Protein in Blood   [ Time Frame: 0 weeks ]

32.  Secondary:   Mean Leptin in Blood   [ Time Frame: 0 weeks ]

33.  Secondary:   Mean Plasminogen Activator Inhibitor-1 in Blood   [ Time Frame: 0 weeks ]


  Serious Adverse Events


  Other Adverse Events


  Limitations and Caveats
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Limitations of the study, such as early termination leading to small numbers of participants analyzed and technical problems with measurement leading to unreliable or uninterpretable data
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  More Information
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Certain Agreements:  
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.


Results Point of Contact:  
Name/Title: Dr. Gladys Velarde
Organization: University of Florida College of Medicine Jacksonville
phone: (904)244-2060
e-mail: Gladys.Velarde@jax.ufl.edu



Responsible Party: Gladys Velarde, University of Rochester
ClinicalTrials.gov Identifier: NCT01785615     History of Changes
Other Study ID Numbers: Protocol No. 1988
Grant# 2004-1035 ( Other Grant/Funding Number: RSRB 29937 )
Study First Received: February 1, 2013
Results First Received: September 3, 2013
Last Updated: April 25, 2017