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Completed

NCT Number: NCT04371133

Anti-inflammatory Markers in Endometrioma

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.

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Key information

Conditions

Endometrioma Endometriosis Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Genital Diseases Genital Diseases, Female Glucose Metabolism Disorders Hyperinsulinism Inflammation Insulin Resistance Metabolic Diseases Nutritional and Metabolic Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Urogenital Diseases

Age range

18 year and older

Sex eligibility

Female

Study type

Observational

Primary location

Mugla Sıtkı Kocman University Faculty of Medicine

Muğla, 48000, Turkey (Türkiye)

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Adropin (ng/L)

Diagnostic Test

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)

Primary outcomes

  1. 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

  2. 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

  3. 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

  4. 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

Sponsors and collaborators

Lead sponsor

Muğla Sıtkı Koçman University

Other

Registry information

Official study title

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

Important dates

Study start
2018
Primary completion
2020
Study completion
2020
First posted
May 1, 2020
Registry last updated
May 1, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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