EndometriomaNCT04371133
Anti-inflammatory Markers in Endometrioma
An observational study of Endometrioma and Inflammation, run by Muğla Sıtkı Koçman University at 1 site in Turkey (Türkiye).
Trial summary
Investigators aimed to measure the serum levels of adropin, salusin-α, netrin-1, and nesfatin-1, anti-inflammatory effects of which have been demonstrated previously, in endometriosis patients and to find out any association of them with insulin resistance. Read more about this study
- Who is it for?
- Ages 18 years and older, women onlyHealthy volunteers can take part
- Conditions the study is for
- Endometrioma, Inflammation
- What is being tested?
- Adropin (ng/L)
- How many people
- 48 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 15 Aug 2018to 15 Mar 2020
- 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 18 years and older
- Women only
- Healthy volunteers accepted
- Adult, Older adult
Study population: Laporoscopically and histopathologically diagnosed 23 endometrioma patients and 25 healthy individuals with no endometrioma constituting the control group were included to this study.
Who may be able to join
- ·Histopathologically confirmed diagnosis of endometrioma
Who cannot join
- Any patients with DM,
- chronic kidney disease (CKD),
- CAD,
- heart failure (HF),
- cerebrovascular accident (CVA),
- malignancy,
Show all 9Show fewer
- rheumatoid disorder,
- liver disease, and
- active infections were excluded from the study.
Trial locations and contacts
1 site in 1 country.
Turkey (Türkiye)1 site
Mugla Sıtkı Kocman University Faculty of Medicine
Muğla, 48000
About this study
Official title: The Role of Serum Adropin, Salusin-α, Netrin-1, and Nesfatin-1 in Endometrioma and Their Association With Insulin Resistance
Investigators aimed to measure the serum levels of adropin, salusin-α, netrin-1, and nesfatin-1, anti-inflammatory effects of which have been demonstrated previously, in endometriosis patients and to find out any association of them with insulin resistance.
Read the detailed description
Endometriosis is defined as the presence of endometrial gland and stroma outside the endometrial cavity affecting almost 10% of the women of reproductive age. Although benign, it disrupts the quality of life of the inflicted patients through symptoms such as dysmenorrhae, dyspareunia, chronic pelvic pain, and infertility. The pathogenesis of endometriosis has not yet been clearly elucidated, however, recent papers implies an underpinning role of inflammation There is a limited number of studies about the levels of these parameters in endometriosis and to date, no report is available on the levels of adropin and netrin-1 in endometriosis. Likewise, according to the investigator's literature search, no research explaining the association of endometriosis with insulin resistance has yet been published. In present study, in an attempt to describe inflammatory pathways playing a role in endometriosis pathogenesis, Investigators aimed to measure the levels of serum adropin, salusin-α, netrin-1, and nesfatin-1, anti-inflammatory effects of which have been priorly demonstrated, and to find out any association of them with insulin resistance.
- Conditions
- Endometrioma, Inflammation
- Being tested
- Adropin (ng/L)
- Keywords
- endometrioma, adropin, salusin-α, netrin-1, nesfatin-1, insulin resistance
- Medical subject headings
- Endometriosis, Inflammation, Insulin Resistance
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Adropin (ng/L)Diagnostic test
Also called Salusin-α (pg/mL), Netrin-1 (pg/mL), Nesfatin-1 (ng/mL)
Thawed samples were measured on a Molecular Devices SpectraMax i3 Multi-Mode, Microplate Reader (batch number: SER 35 370-1448, made in Austria) using enzyme linked immunosorbent assay (ELISA).
| Study group | Role | What they receive |
|---|---|---|
| Endometrioma | Endometrioma (n=23) Receives: Diagnostic Test: Adropin (ng/L) | |
| Healthy controls | Healthy controls Healthy volunteers n=25 Receives: Diagnostic Test: Adropin (ng/L) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum Adropin level
Serum Adropin level in ng/L
Measured: preoperative in the morning or Day 1 in outpatient clinic,preprandial for healthy volunteers
Salusin-α
Serum Salusin-α level in pg/mL
Measured: preoperative in the morning or Day 1 in outpatient clinic, preprandial for healthy volunteers
Netrin-1
Serum Netrin-1 level in pg/mL
Measured: preoperative in the morning or Day 1 in outpatient clinic, preprandial for healthy volunteers
Nesfatin-1
Serum Nesfatin-1 level in ng/L
Measured: preoperative in the morning or Day 1 in outpatient clinic, preprandial for healthy volunteers
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 May 2020
- Study start15 Aug 2018
- Primary completion15 Feb 2020
- Study completion15 Mar 2020
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for EndometriomaStudies 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
- Case-control
- Time perspective
- Prospective
- Enrolment
- 48 participants (actual)
Sponsor and investigators
- Lead sponsor
- Muğla Sıtkı Koçman University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Burak Sezgin, Muğla Sıtkı Koçman University
- Investigators
- Burak Sezgin, Dr, Principal investigator, Mugla Sıtkı Kocman University Faculty of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04371133
- Sponsor's protocol ID
- 22/08/2019-05
- Status last verified
- Apr 2020
- First submitted
- 25 Apr 2020
- Last updated
- 1 May 2020
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 1 May 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Serum Adropin, Salusin-α, Netrin-1, and Nesfatin-1 in Endometrioma and Their Association With Insulin Resistance
- ClinicalTrials.gov ID
- NCT04371133
- Acronym / sponsor ID
- 22/08/2019-05
- Conditions
- Endometrioma, Inflammation
- Keywords
- endometrioma, adropin, salusin-α, netrin-1, nesfatin-1, insulin resistance
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 48 participants (actual)
- Lead sponsor
- Muğla Sıtkı Koçman UniversityUniversity, hospital or other
- Study start
- 15 Aug 2018 (actual)
- Primary completion
- 15 Feb 2020 (actual)
- Study completion
- 15 Mar 2020 (actual)
- First posted
- 1 May 2020 (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.
Investigators aimed to measure the serum levels of adropin, salusin-α, netrin-1, and nesfatin-1, anti-inflammatory effects of which have been demonstrated previously, in endometriosis patients and to find out any association of them with insulin resistance.
Detailed description
Endometriosis is defined as the presence of endometrial gland and stroma outside the endometrial cavity affecting almost 10% of the women of reproductive age. Although benign, it disrupts the quality of life of the inflicted patients through symptoms such as dysmenorrhae, dyspareunia, chronic pelvic pain, and infertility. The pathogenesis of endometriosis has not yet been clearly elucidated, however, recent papers implies an underpinning role of inflammation There is a limited number of studies about the levels of these parameters in endometriosis and to date, no report is available on the levels of adropin and netrin-1 in endometriosis. Likewise, according to the investigator's literature search, no research explaining the association of endometriosis with insulin resistance has yet been published. In present study, in an attempt to describe inflammatory pathways playing a role in endometriosis pathogenesis, Investigators aimed to measure the levels of serum adropin, salusin-α, netrin-1, and nesfatin-1, anti-inflammatory effects of which have been priorly demonstrated, and to find out any association of them with insulin resistance.
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Endometrioma | – | Diagnostic Test: Adropin (ng/L)Endometrioma (n=23) |
| Healthy controls | – | Diagnostic Test: Adropin (ng/L)Healthy controls Healthy volunteers n=25 |
Who may qualify
- Ages
- 18 years and older
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Laporoscopically and histopathologically diagnosed 23 endometrioma patients and 25 healthy individuals with no endometrioma constituting the control group were included to this study.
Key inclusion criteria (1 listed)
- ·Histopathologically confirmed diagnosis of endometrioma
Key exclusion criteria (9 listed)
- Any patients with DM,
- chronic kidney disease (CKD),
- CAD,
- heart failure (HF),
- cerebrovascular accident (CVA),
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Adropin (ng/L)Also: Salusin-α (pg/mL), Netrin-1 (pg/mL), Nesfatin-1 (ng/mL)Thawed samples were measured on a Molecular Devices SpectraMax i3 Multi-Mode, Microplate Reader (batch number: SER 35 370-1448, made in Austria) using enzyme linked immunosorbent assay (ELISA). | Diagnostic test | Endometrioma, Healthy controls |
Primary outcome
Serum Adropin level
Time frame: preoperative in the morning or Day 1 in outpatient clinic,preprandial for healthy volunteers
Serum Adropin level in ng/L
Salusin-α
Time frame: preoperative in the morning or Day 1 in outpatient clinic, preprandial for healthy volunteers
Serum Salusin-α level in pg/mL
Netrin-1
Time frame: preoperative in the morning or Day 1 in outpatient clinic, preprandial for healthy volunteers
Serum Netrin-1 level in pg/mL
Nesfatin-1
Time frame: preoperative in the morning or Day 1 in outpatient clinic, preprandial for healthy volunteers
Serum Nesfatin-1 level in ng/L
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 1 May 2020.
- Individual participant dataSharing planned: Undecided
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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.
Burak Sezgin, Dr principal investigator
Mugla Sıtkı Kocman University Faculty of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Endometrioma and Inflammation, run by Muğla Sıtkı Koçman University at 1 site in Turkey (Türkiye).
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 9 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 1 May 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
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?
Serum Adropin level (time frame: preoperative in the morning or Day 1 in outpatient clinic,preprandial for healthy volunteers). The study lists 4 primary outcomes in all. 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 1 May 2020.