Effect of TyG Index on Outcomes of Radical Prostatectomy | NCT03447028

Studies
Effect of TyG Index on Outcomes of Radical Prostatectomy

NCT03447028

Sponsor

Recep Tayyip Erdogan University Training and Research Hospital

Status

Completed

Last Update Posted

Feb 27, 2018Actual

Enrollment

200Actual

Phase

Not provided

Conditions

Metabolic Syndrome
Prostate Cancer
Insulin Resistance

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

Feb 2018

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 1, 2007Actual

Primary Completion Date

Dec 30, 2012Actual

Completion Date

Dec 30, 2012Actual

First Submitted Date

Feb 20, 2018

First Submission Date that Met QC Criteria

Feb 24, 2018

First Posted Date

Feb 27, 2018Actual

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

Feb 24, 2018

Last Update Posted Date

Feb 27, 2018Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Mustafa Ozan HORSANALI, Urologist, Recep Tayyip Erdogan University Training and Research HospitalPrincipal Investigator

Lead Sponsor

Recep Tayyip Erdogan University Training and Research HospitalOTHER

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

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

We investigate the association between Triglyserid-Glucose(TyG) index and prostate cancer in patients undergoing radical prostatectomy.

Detailed Description

TyG index is calculated with special formula. Patients undergoing radical prostatectomy are divided two groups according to the cut-off level of 8.55 for TyG index.Groups were compared statistically in terms of oncological outcomes and survival.

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Yes

Target Follow-Up Duration

5 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

200Actual

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Oncological outcomes	Effect of TyG index on oncological outcomes of Prostate cancer	5 years

Secondary Outcomes

Measure	Description	Time Frame
Survival	Death date of patient after radical prostatectomy	5 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients undergoing radical prostatectomy for prostate cancer

Exclusion Criteria:

taking medicines for established diabetes and dyslipidaemia,
presence of endocrinological disease,
history of bariatric surgery,
missing data and patients with uncontrolled follow-up

Accepts Healthy Volunteers

Sex

Male

Sex/Gender Based

Yes

Sex/Gender Description

Male patients undergoing radical prostatectomy

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

patients undergoing radical prostatectomy for prostate cancer between january 2007 and december 2012.

Sampling Method

Non-Probability Sample

Condition Browse Module

MeSH Terms

ID	Term
D024821	Metabolic Syndrome
D011471	Prostatic Neoplasms
D007333	Insulin Resistance

Ancestor Terms

ID	Term
D006946	Hyperinsulinism
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided