Anti-inflammatory Markers in Endometrioma

Inflammation Clinical Trial

Official title:

The Role of Serum Adropin, Salusin-α, Netrin-1, and Nesfatin-1 in Endometrioma and Their Association With Insulin Resistance

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04371133
• Other study ID #: 22/08/2019-05
• Status: Completed
• Start date: August 15, 2018
• Est. completion date: March 15, 2020

Study information

• Verified date: April 2020
• Source: Mugla Sitki Koçman University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 48
• Est. completion date: March 15, 2020
• Est. primary completion date: February 15, 2020
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Endometrioma
• Endometriosis
• Inflammation

Intervention

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).

Locations

Country	Name	City	State
Turkey	Mugla Sitki Kocman University Faculty of Medicine	Mugla

Sponsors (1)

Lead Sponsor	Collaborator
Mugla Sitki Koçman University

Country where clinical trial is conducted

Turkey, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Serum Adropin level	Serum Adropin level in ng/L	preoperative in the morning or Day 1 in outpatient clinic,preprandial for healthy volunteers
Primary	Salusin-a	Serum Salusin-a level in pg/mL	preoperative in the morning or Day 1 in outpatient clinic, preprandial for healthy volunteers
Primary	Netrin-1	Serum Netrin-1 level in pg/mL	preoperative in the morning or Day 1 in outpatient clinic, preprandial for healthy volunteers
Primary	Nesfatin-1	Serum Nesfatin-1 level in ng/L	preoperative in the morning or Day 1 in outpatient clinic, preprandial for healthy volunteers