Sex Hormones and Pericardial Adipose Tissue | NCT03035526

Studies
Sex Hormones and Pericardial Adipose Tissue

NCT03035526

Sponsor

Gulhane School of Medicine

Status

Completed

Last Update Posted

Jan 30, 2017Estimated

Enrollment

3,213Actual

Phase

Not provided

Conditions

Pericardial Adipose Tissue and Sex Hormones

Interventions

Not provided

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Jan 2017

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 2000Actual

Primary Completion Date

Jan 2002Actual

Completion Date

Jan 2002Actual

First Submitted Date

Jan 24, 2017

First Submission Date that Met QC Criteria

Jan 25, 2017

First Posted Date

Jan 30, 2017Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jan 25, 2017

Last Update Posted Date

Jan 30, 2017Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

In this study, our aim is to show the relation between sex hormones and PAT and to confirm whether PAT is associated with coronary artery calcification (CAC) in different testosterone levels in the males.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

3,213Actual

Label	Type	Description	Intervention Names
3161 men (45-84 years old)		3161 men without known coronary artery disease

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Relation ship between pericardial adipose tissue and sex hormones in males	Total testosterone and sex hormone binding globulin levels were related with pericardial adipose tissue	years

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

3213 males
African American
Caucasian
Asian (largely Chinese) and Hispanic adults aged 45-84 years and free of known cardiovascular disease at baseline (2000-2002)

Exclusion Criteria:

Patients with known coronary artery disease

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

45 Years

Maximum Age

84 Years

Standard Ages

AdultOlder Adult

Study Population

3161 men (45-84 years old; white, black, Hispanic, or Chinese) at 6 centers in the United States

Sampling Method

Probability Sample