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The Relationship Between Adipokines, Obesity and Insulin Resistance in Women With Polycystic Ovarian Syndrome

Sponsor
Ain Shams University (Other)
Overall Status
Completed
CT.gov ID
NCT02869750
Collaborator
(none)
300
Enrollment
1
Location
22
Actual Duration (Months)
13.6
Patients Per Site Per Month

Study Details

Study Description

Brief Summary

To evaluate possible clinical effects of adipokines , ( ghrelin, resistin and adiponectin), in obese and non-obese patients with polycystic ovary syndrome (PCOS).

Condition or Disease Intervention/Treatment Phase

    Detailed Description

    Seventy selected PCOS patients will be recruited for this study, and will be divided into two groups based on their body mass index (BMI): 35 obese (BMI≥ 25 kg/m2, group A), 35 non-obese (BMI<25 kg/m2, group B). In addition, 35 healthy non-obese women (BMI<25 kg/m2) will bw enrolled as the control (group C). Serum levels of FSH (follicle stimulating hormone), LH (luteinizing hormone), T(testosterone), glucose, insulin, adiponectin, resistin and resistin will bw detected, and compared the differences of them among three groups

    Study Design

    Study Type:
    Observational
    Actual Enrollment :
    300 participants
    Observational Model:
    Cohort
    Time Perspective:
    Prospective
    Official Title:
    Evaluation of Adipokines ( Ghrelin, Resistin and Adiponectin), in Egyptian Women With Polycystic Ovary Syndrome
    Actual Study Start Date :
    Nov 1, 2016
    Actual Primary Completion Date :
    Sep 1, 2018
    Actual Study Completion Date :
    Sep 1, 2018

    Arms and Interventions

    Arm Intervention/Treatment
    Obese PCOS

    PCOS patients with BMI more than 25 kg/m2
    Lean PCOS

    PCOS patients with BMI less than 25 kg/m2
    PCOS with normal HOMA2-1R

    PCOS without Insuline resistance
    PCOS with elevated HOMA2-IR

    PCOS with Insuline resistance

    Outcome Measures

    Primary Outcome Measures

    1. serum ghrelin level [24 hours]

      measuring ghrelin, and ) in the three groups

    2. serum resistin level [24 hours]

      serum resistin level in the three groups

    3. serum adiponectin level [24 hours]

      serum adiponectin level in the three groups

    Secondary Outcome Measures

    1. Glucose/Insulin ratio [24 hours]

      fasting glucose and insulin in three groups

    2. serum testosterone level [24 hours after labor]

      serum testosterone level in three groups

    Eligibility Criteria

    Criteria

    Ages Eligible for Study:
    18 Years to 40 Years
    Sexes Eligible for Study:
    Female
    Accepts Healthy Volunteers:
    Yes
    Inclusion Criteria:
    • Females with PCOS in child bearing age who presented at reproductive and endocrinology clinics at Ain Shams University Maternity Hospital
    Exclusion Criteria:

    • Known androgen secreting tumor.

    • PCO on ovarian stimulation medications

    • PCO with any other medical illness.

    Contacts and Locations

    Locations

    Site City State Country Postal Code
    1 Ahmed Kotb Cairo Al Qahirah Egypt

    Sponsors and Collaborators

    • Ain Shams University

    Investigators

    None specified.

    Study Documents (Full-Text)

    None provided.

    More Information

    Publications

    None provided.
    Responsible Party:
    Ahmed Mohamed El Kotb Abdel Fattah, Lecturer in obstertics and gynecology, Ain Shams University Hospital, Ain Shams University
    ClinicalTrials.gov Identifier:
    NCT02869750
    Other Study ID Numbers:
    • ADIPCOS
    First Posted:
    Aug 17, 2016
    Last Update Posted:
    Oct 2, 2018
    Last Verified:
    Feb 1, 2018
    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
    Additional relevant MeSH terms:
    Polycystic Ovary Syndrome
    Syndrome

    Study Results

    No Results Posted as of Oct 2, 2018