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

Evaluation of Adipokines ( Ghrelin, Resistin and Adiponectin), in Egyptian Women With Polycystic Ovary Syndrome

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

Study Overview

• Status: Completed
• Conditions: Polycystic Ovarian Syndrome

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 Type: Observational
• Enrollment (Actual): 300

Contacts and Locations

Study Locations

• Egypt
  • Al Qahirah
    • Cairo, Al Qahirah, Egypt
      • Ahmed Kotb

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 16 years to 38 years (Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: Female

• 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

Description

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.

Study Plan

How is the study designed?

Design Details

• Observational Models: Cohort
• Time Perspectives: Prospective

Number of groups / cohorts

4

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
serum ghrelin level	measuring ghrelin, and ) in the three groups	24 hours
serum resistin level	serum resistin level in the three groups	24 hours
serum adiponectin level	serum adiponectin level in the three groups	24 hours

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Glucose/Insulin ratio	fasting glucose and insulin in three groups	24 hours
serum testosterone level	serum testosterone level in three groups	24 hours after labor

Collaborators and Investigators

• Sponsor: Ain Shams University

Study record dates

Study Major Dates

• Study Start (Actual): November 1, 2016
• Primary Completion (Actual): September 1, 2018
• Study Completion (Actual): September 1, 2018

Study Registration Dates

• First Submitted: August 5, 2016
• First Submitted That Met QC Criteria: August 16, 2016
• First Posted (Estimate): August 17, 2016

Study Record Updates

• Last Update Posted (Actual): October 2, 2018
• Last Update Submitted That Met QC Criteria: September 30, 2018
• Last Verified: February 1, 2018

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Endocrine System Diseases; Disease; Ovarian Cysts; Cysts; Ovarian Diseases; Adnexal Diseases; Gonadal Disorders; Polycystic Ovary Syndrome; Syndrome
• Other Study ID Numbers: ADIPCOS

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: Undecided

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No