Trial · NCT01785615

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

NCT01785615, Phase 1, Phase 2, Completed, University of Rochester; results first posted 2017-06-07

3 sourcestrials-2026-11-12-0.5.0

Cite this record

ConductScience Library. Prothrombotic Inflammatory Markers in Women With Metabolic Syndrome - Effect of Atorvastatin. Trials, record NCT01785615. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT01785615

On this page

Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title: Prothrombotic Inflammatory Markers in Women With Metabolic Syndrome - Effect of Atorvastatin
NCT number: NCT01785615
Status: Completed
Phases: Phase 1, Phase 2
Enrollment: 116 participants, actual
Lead sponsor: University of Rochester
Conditions: Metabolic Syndrome
Interventions: Atorvastatin, Placebo
First posted: 2013-02-07
Last updated: 2017-06-07
Results first posted: 2017-06-07

Source ClinicalTrials.gov

Registered outcomes33

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

List	Outcome	Time frame	Description
Primary	Mean Low Density Lipoprotein Cholesterol in Blood	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.
Primary	Mean Triglycerides in Blood	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.
Primary	Mean Apolipoprotein B in Blood	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.
Primary	Mean Apolipoprotein B/ Apolipoprotein A1 Ratio in Blood	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.
Primary	Mean High Sensitivity C-reactive Protein in Blood	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
Primary	Mean Waist Circumference	6 weeks	Waist circumference was measured with a ruler tape.
Primary	Mean Systolic Blood Pressure	6 weeks	Measured with a blood pressure cuff
Primary	Mean Diastolic Blood Pressure	6 weeks	Measured with a blood pressure cuff
Primary	Mean High Density Lipoprotein Cholesterol in Blood	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.
Primary	Mean Fasting Plasma Glucose in Blood	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.

1 to 10 of 33Source ClinicalTrials.gov

See all 33 registered outcomes

Outcomes33

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

Type	Outcome	Time frame	Units	Measured as
PRIMARY	Mean Low Density Lipoprotein Cholesterol in Blood	6 weeks	mg/dl	MEAN
PRIMARY	Mean Triglycerides in Blood	6 weeks	mg/dl	MEAN
PRIMARY	Mean Apolipoprotein B in Blood	6 weeks	mg/dl	MEAN
PRIMARY	Mean Apolipoprotein B/ Apolipoprotein A1 Ratio in Blood	6 weeks	ratio	MEAN
PRIMARY	Mean High Sensitivity C-reactive Protein in Blood	6 weeks	ng/dl	MEAN
PRIMARY	Mean Waist Circumference	6 weeks	inches	MEAN
PRIMARY	Mean Systolic Blood Pressure	6 weeks	mm Hg	MEAN
PRIMARY	Mean Diastolic Blood Pressure	6 weeks	mm Hg	MEAN
PRIMARY	Mean High Density Lipoprotein Cholesterol in Blood	6 weeks	mg/dl	MEAN
PRIMARY	Mean Fasting Plasma Glucose in Blood	6 weeks	mg/dl	MEAN

1 to 10 of 33Source ClinicalTrials.gov

See all 33 outcomes

Results by group66

Each measurement the trial posted, group by group, in the words and numbers it posted.

Outcome	Group	Value	Spread	Units
Mean Low Density Lipoprotein Cholesterol in Blood	Atorvastatin	70	Standard Deviation 24.8	mg/dl
Mean Low Density Lipoprotein Cholesterol in Blood	Sugar Pill	135	Standard Deviation 31.4	mg/dl
Mean Triglycerides in Blood	Atorvastatin	139	Standard Deviation 54.84	mg/dl
Mean Triglycerides in Blood	Sugar Pill	185	Standard Deviation 65.4	mg/dl
Mean Apolipoprotein B in Blood	Atorvastatin	63	Standard Deviation 23	mg/dl
Mean Apolipoprotein B in Blood	Sugar Pill	110	Standard Deviation 23	mg/dl
Mean Apolipoprotein B/ Apolipoprotein A1 Ratio in Blood	Atorvastatin	0.48	Standard Deviation 0.18	ratio
Mean Apolipoprotein B/ Apolipoprotein A1 Ratio in Blood	Sugar Pill	0.86	Standard Deviation 0.19	ratio
Mean High Sensitivity C-reactive Protein in Blood	Atorvastatin	3095	Standard Deviation 1778.8	ng/dl
Mean High Sensitivity C-reactive Protein in Blood	Sugar Pill	4027	Standard Deviation 1583.8	ng/dl

1 to 10 of 66Source ClinicalTrials.gov

See all 66 results by group

Participant flow24

How many started, completed or left each group, period by period.

Period	Milestone	Group	Participants
Dietary Phase	STARTED	Atorvastatin	0
Dietary Phase	STARTED	Sugar Pill	0
Dietary Phase	STARTED	Healthy Women	35
Dietary Phase	STARTED	Metabolic Syndrome Women	140
Dietary Phase	COMPLETED	Atorvastatin	0
Dietary Phase	COMPLETED	Sugar Pill	0
Dietary Phase	COMPLETED	Healthy Women	35
Dietary Phase	COMPLETED	Metabolic Syndrome Women	116
Dietary Phase	NOT COMPLETED	Atorvastatin	0
Dietary Phase	NOT COMPLETED	Sugar Pill	0

1 to 10 of 24Source ClinicalTrials.gov

See all 24 participant flow

Adverse events0

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

None in this release.

Adverse event totals6

The totals the trial posted for each group.

Total	Group	Affected	At risk
Total, all-cause mortality	Atorvastatin
Total, all-cause mortality	Sugar Pill
Total, other adverse events	Atorvastatin	0	44
Total, other adverse events	Sugar Pill	0	44
Total, serious adverse events	Atorvastatin	0	44
Total, serious adverse events	Sugar Pill	0	44

Source ClinicalTrials.gov

Papers1

The papers the trial lists on ClinicalTrials.gov.

PMID	Listed as
33485731	DERIVED

Source PubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons1

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

Comparison
Atorvastatin vs Sugar Pill: serious adverse events

Source Trial comparisons

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov: 2026-11-12; ClinicalTrials.gov
Results, from AACT: 2026-03-23; AACT
NIH grant links: 2026-11-13; NIH RePORTER

Sources 3

ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
ClinicalTrials.govNo license stated
NIH RePORTER's clinical studies and project filesPublic domain

Each source's terms

ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
ClinicalTrials.govnone stated
NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

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