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

Completed

• Conditions: Obesity; Polycystic Ovary Syndrome
• Interventions: Other: Evaluation

• Registration Number: NCT06164132
• Lead Sponsor: Cairo University

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2023-07-01
• Primary Completion: 2023-10-31
• Study Completion: 2023-10-31
• Study First Submitted: 2023-12-01
• Study First Submitted QC: 2023-12-01
• Study First Posted: 2023-12-11
• Status Verified: 2024-02
• Last Update Submitted: 2024-02-13
• Last Update Posted: 2024-02-14

Recruitment & Eligibility

• Status: COMPLETED
• Sex: Female
• Target Recruitment: 100

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.

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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.

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
Overweight group	Evaluation	Their BMI ranged from 25 to 29.9 kg/m2.
Obese group	Evaluation	Their BMI was ≥ 30 kg/m2.
Normal Weight group	Evaluation	Their BMI ranged from 18.5 to 24.9 kg/m2.

Primary Outcome Measures

Name	Time	Method
Total and regional fat mass	4 months	They were measured by Dual-energy X-ray absorptiometry.
Body mass index (BMI)	4 months	The height and weight were determined for each female in the three groups to calculate her BMI = (weight in kg)/(height in m2)
Waist hip ratio (WHR)	4 months	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).
End diastolic velocity (EDV)	4 months	It was recorded for each female in the three groups by Color Doppler ultrasound.
Pulsatility index (PI)	4 months	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.
Phenotypes of PCOS	4 months	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).
Total and regional lean mass	4 months	They were measured by Dual-energy X-ray absorptiometry.
Resistive index (RI)	4 months	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
Ovarian volume	4 months	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.
Peak systolic velocity (PSV)	4 months	It was recorded for each female in the three groups by Color Doppler ultrasound.

Trial Locations

Locations (1)

Cairo University; 🇪🇬 Giza, Egypt