Metabolic SyndromeTyG-PCaNCT03447028
Effect of TyG Index on Outcomes of Radical Prostatectomy
An observational study of Metabolic Syndrome and Prostate Cancer, run by Recep Tayyip Erdogan University Training and Research Hospital.
Trial summary
We investigate the association between Triglyserid-Glucose(TyG) index and prostate cancer in patients undergoing radical prostatectomy. Read more about this study
- Who is it for?
- Any age, men only
- Conditions the study is for
- Metabolic Syndrome, Prostate Cancer, Insulin Resistance
- How many people
- 200 participants
- Where
- No sites listed yet
- Study dates
- 1 Jan 2007to 30 Dec 2012
- How long will I take part?
- 5 Years
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages Any age
- Men only
- No healthy volunteers
- Child, Adult, Older adult
Study population: patients undergoing radical prostatectomy for prostate cancer between january 2007 and december 2012.
Who may be able to join
- Patients undergoing radical prostatectomy for prostate cancer
Who cannot join
- taking medicines for established diabetes and dyslipidaemia,
- presence of endocrinological disease,
- history of bariatric surgery,
- missing data and patients with uncontrolled follow-up
About this study
Official title: A Novel Prognostic Risk Factor for Patients Undergoing Radical Prostatectomy: Triglyseride-Glucose (TyG) Index
We investigate the association between Triglyserid-Glucose(TyG) index and prostate cancer in patients undergoing radical prostatectomy.
Read the 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.
- Conditions
- Metabolic Syndrome, Prostate Cancer, Insulin Resistance
- Keywords
- Triglyseride-Glucose index, prostate cancer, radical prostatectomy, metabolic syndrome
- Medical subject headings
- Metabolic Syndrome, Prostatic Neoplasms, Insulin Resistance
What is being measured
The primary outcome is the main question the study is designed to answer.
Oncological outcomes
Effect of TyG index on oncological outcomes of Prostate cancer
Measured: 5 years
Secondary outcomes (1)
Survival
Death date of patient after radical prostatectomy
Measured: 5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Feb 2018
- Study start1 Jan 2007
- Primary completion30 Dec 2012
- Study completion30 Dec 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Metabolic SyndromeStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 200 participants (actual)
- Target duration
- 5 Years
Sponsor and investigators
- Lead sponsor
- Recep Tayyip Erdogan University Training and Research Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mustafa Ozan HORSANALI, Recep Tayyip Erdogan University Training and Research Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03447028
- Sponsor's protocol ID
- Recepteutrh
- Acronym
- TyG-PCa
- Status last verified
- Feb 2018
- First submitted
- 20 Feb 2018
- Last updated
- 27 Feb 2018
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Feb 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Novel Prognostic Risk Factor for Patients Undergoing Radical Prostatectomy: Triglyseride-Glucose (TyG) Index
- ClinicalTrials.gov ID
- NCT03447028
- Acronym / sponsor ID
- TyG-PCa / Recepteutrh
- Conditions
- Metabolic Syndrome, Prostate Cancer, Insulin Resistance
- Keywords
- Triglyseride-Glucose index, prostate cancer, radical prostatectomy, metabolic syndrome
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 200 participants (actual)
- Lead sponsor
- Recep Tayyip Erdogan University Training and Research HospitalUniversity, hospital or other
- Study start
- 1 Jan 2007 (actual)
- Primary completion
- 30 Dec 2012 (actual)
- Study completion
- 30 Dec 2012 (actual)
- First posted
- 27 Feb 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Target follow-up
- 5 Years
Who may qualify
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
- Study population
- patients undergoing radical prostatectomy for prostate cancer between january 2007 and december 2012.
Key inclusion criteria (1 listed)
- Patients undergoing radical prostatectomy for prostate cancer
Key exclusion criteria (4 listed)
- taking medicines for established diabetes and dyslipidaemia,
- presence of endocrinological disease,
- history of bariatric surgery,
- missing data and patients with uncontrolled follow-up
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Oncological outcomes
Time frame: 5 years
Effect of TyG index on oncological outcomes of Prostate cancer
1 secondary outcome
Survival
Time frame: 5 years
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Feb 2018.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
Questions about this trial
What is this clinical trial studying?
An observational study of Metabolic Syndrome and Prostate Cancer, run by Recep Tayyip Erdogan University Training and Research Hospital.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 27 Feb 2018. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Oncological outcomes (time frame: 5 years). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 27 Feb 2018.