Anti-inflammatory Markers in Endometrioma

Completed

• Conditions: Inflammation; Endometrioma
• Interventions: Diagnostic Test: Adropin (ng/L)

• Registration Number: NCT04371133
• Lead Sponsor: Muğla Sıtkı Koçman University

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.

Study Timeline

• Study Start: 2018-08-15
• Primary Completion: 2020-02-15
• Study Completion: 2020-03-15
• Status Verified: 2020-04
• Study First Submitted: 2020-04-25
• Study First Submitted QC: 2020-04-30
• Last Update Submitted: 2020-04-30
• Study First Posted: 2020-05-01
• Last Update Posted: 2020-05-01

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 48

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.

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Endometrioma	Adropin (ng/L)	Endometrioma (n=23)
Healthy controls	Adropin (ng/L)	Healthy controls Healthy volunteers n=25

Primary Outcome Measures

Name	Time	Method
Serum Adropin level	preoperative in the morning or Day 1 in outpatient clinic,preprandial for healthy volunteers	Serum Adropin level in ng/L
Salusin-α	preoperative in the morning or Day 1 in outpatient clinic, preprandial for healthy volunteers	Serum Salusin-α level in pg/mL
Netrin-1	preoperative in the morning or Day 1 in outpatient clinic, preprandial for healthy volunteers	Serum Netrin-1 level in pg/mL
Nesfatin-1	preoperative in the morning or Day 1 in outpatient clinic, preprandial for healthy volunteers	Serum Nesfatin-1 level in ng/L

Trial Locations

Locations (1)

Mugla Sıtkı Kocman University Faculty of Medicine; 🇹🇷 Muğla, Turkey