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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT02869750
Other study ID # ADIPCOS
Secondary ID
Status Completed
Phase
First received
Last updated
Start date November 2016
Est. completion date September 2018

Study information

Verified date February 2018
Source Ain Shams University
Contact n/a
Is FDA regulated No
Health authority
Study type Observational

Clinical Trial Summary

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


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


Recruitment information / eligibility

Status Completed
Enrollment 300
Est. completion date September 2018
Est. primary completion date September 2018
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Female
Age group 18 Years to 40 Years
Eligibility 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 Design


Locations

Country Name City State
Egypt Ahmed Kotb Cairo Al Qahirah

Sponsors (1)

Lead Sponsor Collaborator
Ain Shams University

Country where clinical trial is conducted

Egypt, 

Outcome

Type Measure Description Time frame Safety issue
Primary serum ghrelin level measuring ghrelin, and ) in the three groups 24 hours
Primary serum resistin level serum resistin level in the three groups 24 hours
Primary serum adiponectin level serum adiponectin level in the three groups 24 hours
Secondary Glucose/Insulin ratio fasting glucose and insulin in three groups 24 hours
Secondary serum testosterone level serum testosterone level in three groups 24 hours after labor
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