Clinical trial NCT04371133: Anti-inflammatory Markers in Endometrioma
Official title: The Role of Serum Adropin, Salusin-α, Netrin-1, and Nesfatin-1 in Endometrioma and Their Association With Insulin Resistance
Study type: OBSERVATIONAL
Overall status: COMPLETED
Conditions: Endometrioma
Inflammation
Keywords: endometrioma
adropin
salusin-α
netrin-1
nesfatin-1
insulin resistance
Lead sponsor: Muğla Sıtkı Koçman University
Sponsor class: OTHER
First posted: 2020-05-01
Enrollment: 48
Sex: FEMALE
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: CASE_CONTROL
Time perspective: PROSPECTIVE
Sampling method: PROBABILITY_SAMPLE
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.

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

·Histopathologically confirmed diagnosis of endometrioma

Exclusion Criteria:

* Any patients with DM,
* chronic kidney disease (CKD),
* CAD,
* heart failure (HF),
* cerebrovascular accident (CVA),
* malignancy,
* rheumatoid disorder,
* liver disease, and
* active infections were excluded from the study.

Primary outcomes:
measure: Serum Adropin level
timeFrame: preoperative in the morning or Day 1 in outpatient clinic,preprandial for healthy volunteers
measure: Salusin-α
timeFrame: preoperative in the morning or Day 1 in outpatient clinic, preprandial for healthy volunteers
measure: Netrin-1
timeFrame: preoperative in the morning or Day 1 in outpatient clinic, preprandial for healthy volunteers
measure: Nesfatin-1
timeFrame: preoperative in the morning or Day 1 in outpatient clinic, preprandial for healthy volunteers
Secondary outcomes:
Other outcomes:
Locations:
city: Muğla
country: Turkey
facility: Mugla Sıtkı Kocman University Faculty of Medicine
Study officials:
affiliation: Mugla Sıtkı Kocman University Faculty of Medicine
name: Burak Sezgin, Dr
role: PRINCIPAL_INVESTIGATOR
References: