Pivotal Influence of Obesity on Body Composition and Ovarian Doppler in Different Polycystic Ovarian Syndrome Phenotypes

Obesity Clinical Trial

Official title:

The Pivotal Influence of Obesity on Body Composition and Ovarian Doppler in Different Polycystic Ovarian Syndrome Phenotypes: An Observational Study

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT06164132
• Other study ID #: P.T.REC/012/004609
• Status: Completed
• Start date: July 1, 2023
• Est. completion date: October 31, 2023

Study information

• Verified date: February 2024
• Source: Cairo University
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The study aimed to explore the impact of obesity on both body composition and ovarian Doppler parameters across various phenotypes of females diagnosed with polycystic ovarian syndrome (PCOS). Additionally, the investigation seeked to establish correlations between these parameters and their prevalence concerning the clinical criteria of PCOS.

Description:

Polycystic ovarian syndrome (PCOS) is a complex and multifactorial condition characterized by endocrinological, reproductive, metabolic, and biochemical abnormalities, affecting 12% to 21% of reproductive-aged females. It has emerged as a significant global public health concern. However, variations in diagnostic criteria and patient selection have led to considerable discrepancies in the absolute prevalence of PCOS and its temporal trends. Previous studies have examined ovarian volume and blood flow indices in both obese and non-obese females with PCOS, albeit employing different criteria for obesity classification. Notably, none have compared these parameters across normal weight, overweight, and obese PCOS females. Therefore, the current study aims to explore the impact of obesity on body composition and ovarian Doppler parameters within distinct PCOS phenotypes. An additional objective is to assess correlations between anthropometric, body composition, and ovarian Doppler parameters and the prevalence of PCOS symptoms.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 100
• Est. completion date: October 31, 2023
• Est. primary completion date: October 31, 2023
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

Inclusion Criteria:

• Age ranged from 18 to 40 years old.

• Individuals with Polycystic Ovary Syndrome (PCOS) should exhibit at least two of the three features outlined in the Rotterdam criteria for diagnosis, encompassing oligo- or anovulation, clinical and/or biochemical indications of hyperandrogenism, and the presence of polycystic ovaries as identified through ultrasonography.

Exclusion Criteria:

• Congenital adrenal hyperplasia

• Thyroid dysfunction

• Hyperprolactinemia

• Androgen-secreting tumors

• Cushing syndrome

• Undergoing any medical therapy for the treatment of PCOS or for weight loss.

Related Conditions & MeSH terms

• Obesity
• Polycystic Ovary Syndrome
• Syndrome

Intervention

Other:
• Evaluation
Evaluation through PCOS Phenotypes, measurements of Body weight, height, waist and hip circumferences, Dual-energy X-ray absorptiometry, and Sonographic examination.

Locations

Country	Name	City	State
Egypt	Cairo University	Giza

Sponsors (3)

Lead Sponsor	Collaborator
Cairo University	Helwan University, National Research Centre, Egypt

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Phenotypes of PCOS	The patients were categorized into four distinct phenotypes: Type I, characterized by oligomenorrhea/amenorrhea and hyperandrogenism (O+H); Type II, exhibiting polycystic ovaries and hyperandrogenism (P+H); Type III, featuring oligomenorrhea/amenorrhea and polycystic ovaries (O+P); and Type IV, presenting with oligomenorrhea/amenorrhea, polycystic ovaries, and hyperandrogenism (O+P+H).	4 months
Primary	Body mass index (BMI)	The height and weight were determined for each female in the three groups to calculate her BMI = (weight in kg)/(height in m2)	4 months
Primary	Waist hip ratio (WHR)	The waist and hip circumferences were taken for each female in the three groups for calculating waist and hip ratio (WHR) by dividing waist circumference (WC) on the hip circumference (HC).	4 months
Primary	Total and regional fat mass	They were measured by Dual-energy X-ray absorptiometry.	4 months
Primary	Total and regional lean mass	They were measured by Dual-energy X-ray absorptiometry.	4 months
Primary	Ovarian volume	The ovarian volume was computed utilizing the ellipsoid formula, which involves multiplying the dimensions of length, width, and height by a constant factor of 0.523.	4 months
Primary	Peak systolic velocity (PSV)	It was recorded for each female in the three groups by Color Doppler ultrasound.	4 months
Primary	End diastolic velocity (EDV)	It was recorded for each female in the three groups by Color Doppler ultrasound.	4 months
Primary	Resistive index (RI)	The Resistance Index (RI) was determined by dividing the difference between Peak Systolic Velocity (PSV) and End Diastolic Velocity (EDV) by PSV. A lower value of RI is indicative of increased blood flow	4 months
Primary	Pulsatility index (PI)	The Pulsatility Index (PI) was calculated by dividing the difference between Peak Systolic Velocity (PSV) and End Diastolic Velocity (EDV) by the mean maximum flow velocity. A reduced PI value is indicative of heightened blood flow.	4 months