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Anti-inflammatory Markers in Endometrioma

Sponsor
Muğla Sıtkı Koçman University (Other)
Overall Status
Completed
CT.gov ID
NCT04371133
Collaborator
(none)
48
Enrollment
1
Location
19
Actual Duration (Months)
2.5
Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease Intervention/Treatment Phase
  • 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 Design

Study Type:
Observational
Actual Enrollment :
48 participants
Observational Model:
Case-Control
Time Perspective:
Prospective
Official Title:
The Role of Serum Adropin, Salusin-α, Netrin-1, and Nesfatin-1 in Endometrioma and Their Association With Insulin Resistance
Actual Study Start Date :
Aug 15, 2018
Actual Primary Completion Date :
Feb 15, 2020
Actual Study Completion Date :
Mar 15, 2020

Arms and Interventions

Arm 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)

    		•

    Outcome Measures

    Primary Outcome Measures

    1. Serum Adropin level [preoperative in the morning or Day 1 in outpatient clinic,preprandial for healthy volunteers]

      Serum Adropin level in ng/L

    2. Salusin-α [preoperative in the morning or Day 1 in outpatient clinic, preprandial for healthy volunteers]

      Serum Salusin-α level in pg/mL

    3. Netrin-1 [preoperative in the morning or Day 1 in outpatient clinic, preprandial for healthy volunteers]

      Serum Netrin-1 level in pg/mL

    4. Nesfatin-1 [preoperative in the morning or Day 1 in outpatient clinic, preprandial for healthy volunteers]

      Serum Nesfatin-1 level in ng/L

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years and Older
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    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.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Mugla Sıtkı Kocman University Faculty of Medicine Muğla Turkey 48000

    Sponsors and Collaborators

    • Muğla Sıtkı Koçman University

    Investigators

    • Principal Investigator: Burak Sezgin, Dr, Mugla Sıtkı Kocman University Faculty of Medicine

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Burak Sezgin, Principal Investigator, Muğla Sıtkı Koçman University
    ClinicalTrials.gov Identifier:
    NCT04371133
    Other Study ID Numbers:
    • 22/08/2019-05
    First Posted:
    May 1, 2020
    Last Update Posted:
    May 1, 2020
    Last Verified:
    Apr 1, 2020
    Individual Participant Data (IPD) Sharing Statement:
    Undecided
    Plan to Share IPD:
    Undecided
    Studies a U.S. FDA-regulated Drug Product:
    No
    Studies a U.S. FDA-regulated Device Product:
    No
    Keywords provided by Burak Sezgin, Principal Investigator, Muğla Sıtkı Koçman University
    endometrioma
    adropin
    salusin-α
    netrin-1
    nesfatin-1
    insulin resistance
    Additional relevant MeSH terms:
    Endometriosis
    Inflammation

    Study Results

    No Results Posted as of May 1, 2020