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CompletedNCT02869750Updated Oct 2, 2018

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

An observational study in Polycystic Ovarian Syndrome, sponsored by Ain Shams University. Completed at 1 site in Egypt. Open to female participants aged 18 Years to 40 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2018-10-02.

Sponsored by Ain Shams University · Observational

Study type
Observational
Model
Cohort
Time perspective
Prospective
Enrollment
300
Ages
18 Years to 40 Years
Sex
Female
01

Study summary

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

Read the 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

02

Conditions studied

  • Polycystic Ovarian Syndrome
03

In context

Polycystic Ovary Syndrome

944 studies on the registry are indexed under Polycystic Ovary Syndrome; 174 are open to participants now.

This study's enrollment of 300 is above the median of 118 across 223 observational studies indexed under Polycystic Ovary Syndrome.

Browse Polycystic Ovary Syndrome studies →

Lead sponsor

Ain Shams University is the lead sponsor of 1,876 studies on the registry; 423 are open to participants now.

Of its 32 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 40 Years
Sexes eligible
Female
Accepts healthy volunteers
Yes
Sampling method
Probability sample

Study population

Females with PCOS in child bearing age who presented at reproductive and endocrinology clinics at Ain Shams University Maternity Hospital

Inclusion criteria

  • Females with PCOS in child bearing age who presented at reproductive and endocrinology clinics at Ain Shams University Maternity Hospital

Exclusion criteria

Exclusion Criteria:

  • Known androgen secreting tumor.
  • PCO on ovarian stimulation medications
  • PCO with any other medical illness.
05

Study design

Observational model
Cohort
Time perspective
Prospective
Enrollment
300 participants (actual)
Patient registry
No
Biospecimen retention
Samples with dna

Groups and cohorts

  • 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

06

What researchers measure

Primary outcomes

  1. serum ghrelin level

    measuring ghrelin, and ) in the three groups

    Time frame: 24 hours

  2. serum resistin level

    serum resistin level in the three groups

    Time frame: 24 hours

  3. serum adiponectin level

    serum adiponectin level in the three groups

    Time frame: 24 hours

Secondary outcomes

  1. Glucose/Insulin ratio

    fasting glucose and insulin in three groups

    Time frame: 24 hours

  2. serum testosterone level

    serum testosterone level in three groups

    Time frame: 24 hours after labor

07

Study locations

1 site
  • Ahmed Kotb
    Cairo, Al Qahirah, Egypt
08

References and documents

Individual participant data

Plan to share: Undecided

No publications or documents are linked to this record.

09

Updates

Tracking since Sep 25, 2026
No changes since tracking began. The registry record was last updated on Oct 2, 2018, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT02869750
Lead sponsor
Ain Shams University
Responsible party
Ahmed Mohamed El Kotb Abdel Fattah (Lecturer in obstertics and gynecology, Ain Shams University Hospital, Ain Shams University) — Principal investigator
First posted
Aug 17, 2016
Start date
Nov 2016
Primary completion
Sep 2018
Completion
Sep 2018
Last update
Oct 2, 2018

Oversight

Data monitoring committee
Yes
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is completed, as verified in Feb 2018. You cannot join it, but the record below documents what was studied.

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