Anti-inflammatory Markers in Endometrioma

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.

Study Overview

• Status: Completed
• Conditions: Inflammation; Endometrioma
• Intervention / Treatment: Diagnostic test: Adropin (ng/L)

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 Type: Observational
• Enrollment (Actual): 48

Contacts and Locations

Study Locations

• Turkey
  • Muğla, Turkey, 48000
    • Mugla Sıtkı Kocman University Faculty of Medicine

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

• 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.

Description

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 Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Endometrioma; Endometrioma (n=23)	Diagnostic test: Adropin (ng/L); 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).; Other Names: Salusin-α (pg/mL); Netrin-1 (pg/mL); Nesfatin-1 (ng/mL)
Healthy controls; Healthy controls Healthy volunteers n=25	Diagnostic test: Adropin (ng/L); 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).; Other Names: Salusin-α (pg/mL); Netrin-1 (pg/mL); Nesfatin-1 (ng/mL)

What is the study measuring?

Primary Outcome Measures

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

Collaborators and Investigators

• Sponsor: Muğla Sıtkı Koçman University
• Investigators: Principal Investigator: Burak SEZGİN, Dr, Mugla Sıtkı Kocman University Faculty of Medicine

Study record dates

Study Major Dates

• Study Start (Actual): August 15, 2018
• Primary Completion (Actual): February 15, 2020
• Study Completion (Actual): March 15, 2020

Study Registration Dates

• First Submitted: April 25, 2020
• First Submitted That Met QC Criteria: April 30, 2020
• First Posted (Actual): May 1, 2020

Study Record Updates

• Last Update Posted (Actual): May 1, 2020
• Last Update Submitted That Met QC Criteria: April 30, 2020
• Last Verified: April 1, 2020

More Information

Terms related to this study

• Keywords: insulin resistance; endometrioma; netrin-1; adropin; salusin-α; nesfatin-1
• Additional Relevant MeSH Terms: Pathologic Processes; Inflammation; Endometriosis
• Other Study ID Numbers: 22/08/2019-05

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No