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临床试验/NCT06164132
NCT06164132已完成不适用

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

Cairo University1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2023年7月1日最近更新:
适应症

试验速览

阶段
不适用
状态
已完成
入组人数
100
试验地点
1
主要终点
Total and regional fat mass

研究概览

简要总结

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.

详细描述

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.

研究设计

研究类型
Observational
观察模型
Other
时间视角
Cross Sectional

入排标准

年龄范围
18 Years 至 40 Years(Adult)
性别
Female
接受健康志愿者

入选标准

  • 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.

排除标准

  • Congenital adrenal hyperplasia
  • Thyroid dysfunction
  • Hyperprolactinemia
  • Androgen-secreting tumors
  • Cushing syndrome
  • Undergoing any medical therapy for the treatment of PCOS or for weight loss.

结局指标

主要结局

Total and regional fat mass

时间窗: 4 months

They were measured by Dual-energy X-ray absorptiometry.

Body mass index (BMI)

时间窗: 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)

时间窗: 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)

时间窗: 4 months

It was recorded for each female in the three groups by Color Doppler ultrasound.

Pulsatility index (PI)

时间窗: 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

时间窗: 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

时间窗: 4 months

They were measured by Dual-energy X-ray absorptiometry.

Resistive index (RI)

时间窗: 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

时间窗: 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)

时间窗: 4 months

It was recorded for each female in the three groups by Color Doppler ultrasound.

次要结局

未报告次要终点

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Doaa A. Osman

Assistant Professor

Cairo University

研究点 (1)

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