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临床试验/NCT04738409
NCT04738409进行中(未招募)不适用

Ovarian Hyperandrogenism in Adolescent Girls and Concomitant Metabolic Changes, Oxidative Stress, Inflammation, Oral Health and Their Relation to Diet

Poznan University of Physical Education4 个研究点 分布在 1 个国家目标入组 200 人开始时间: 2018年4月1日最近更新:
适应症

试验速览

阶段
不适用
状态
进行中(未招募)
发起方
入组人数
200
试验地点
4
主要终点
Blood parameters

研究概览

简要总结

The objective was

  1. to check whether serum androgen levels and concomitant metabolic changes, oxidative stress and inflammation in adolescent girls with hyperandrogenism may be related to diet.
  2. to identify the factors that increase the risk of being overweight and of obesity among adolescents with clinical features of PCOS, related to diet and DEA (Disordered Eating Attitudes)
  3. to investigate the relationships between markers of oxidation and markers of Systemic Inflammation and macronutrients intake
  4. to assess the relation between oral health of girls with PCOS (including condition of periodontium and dental caries) and their dietary habits, hormonal, metabolic and oxidative and inflammatory status.

详细描述

Hyperandrogenism in women is a state of increased androgen production, manifested by irregular menstrual cycles, a more frequent incidence of infertility, metabolic syndrome, oxidative stress, and inflammation, as well as acne and hirsutism. In addition to ovulation disorders and the multifollicular ovaries structure in an ultrasound examination, hyperandrogenism is a typical clinical feature of the Polycystic Ovary Syndrome (PCOS), which is diagnosed in approximately 8.6% of adolescent girls. Excessive body weight makes it difficult to diagnose at an early stage of the disease and intensifies metabolic and hormonal disorders, as well as those related to oxidative stress and inflammation of the body. Some research studies suggest that PCOS may negatively affect oral health of women, increasing the risk of periodontal problems.

The main purpose of this research was to check whether serum androgen levels and concomitant metabolic changes, oxidative stress and inflammation in adolescent girls with hyperandrogenism may be related to diet.

The investigators aimed to identify the factors that increase the risk of being overweight and of obesity among adolescents with clinical features of PCOS, related to diet and DEA(Disordered Eating Attitudes).

The objective was also to investigate the relationships between markers of oxidation and markers of Systemic Inflammation and macronutrients intake, such as carbohydrates and fiber, protein (animal, plant), fats and cholesterol in normal and overweight/obese girls with clinical features of PCOS.

Additionally, the investigators would like to evaluate the relation between oral health of girls with PCOS (including condition of periodontium and dental caries) and their dietary habits, hormonal, metabolic and oxidative and inflammatory status.

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Treatment
盲法
Single (Participant)

入排标准

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

入选标准

  • The criteria for the patient's inclusion were based on the 2003 Rotterdam criteria, with the presence of at least two of the following:
  • written consent for inclusion (girls and their parents)
  • clinical and/or biochemical hyperandrogenism (hirsutism with moderate to severe acne, and/or elevation of serum total testosterone or free testosterone,
  • oligoovulation (based on oligomenorrhea defined as bleeding episodes occurring less than 8 times per year or secondary amenorrhea),
  • polycystic ovarian picture in an ultrasound examination (at least 12 follicles in each ovary each measuring 2-9 mm in diameter and/or ovarian volume >10 mL).

排除标准

  • any systemic disease, thyroid dysfunction, diabetes, congenital adrenal hyperplasia, Cushing syndrome, hyperprolactinemia suggestive of pituitary adenoma and androgen-secreting tumors
  • medications of continuous use,
  • the use of hormonal therapy or antibiotics in the past three months,
  • vitamin or supplements use,
  • alcohol consumption

结局指标

主要结局

Blood parameters

时间窗: 2018-2022

Hormonal and biochemical parameters, including follicle-stimulating hormone (FSH), luteinizing hormone (LH), total testosterone, androstenedione, estradiol, dehydroepiandrosterone (DHEA-S), Sex Hormone Binding Globulin (SHBG), fasting glucose and fasting insulin, total cholesterol (TC), high-density lipoprotein cholesterol (HDL-C), and triglycerides (TG), 17 OH-Progesterone, Prolactin, Cortisol, Thyroid-stimulating hormone (TSH), will be measured in the morning after overnight fasting.

Anthropometric Assessment

时间窗: 2018-2022

Body mass index BMI: derived from measured body height (m) and body weight (kg) as body weight / height². Weight will be measured to the nearest 0.1 kg using digital medical scales. Height will be measured with a stadiometer attached to the scales. Waist circumference (WC) will be measured to the nearest 0.1 mm using anthropometric tape between the lower border of rib margin and the upper border of iliac crest (WC-mid).

Body Composition

时间窗: 2018-2022

Body composition will be assessed with a body composition analyzer (BIA method). The measurements of fat mass (FM) will be expressed as a percentage (%) and kilograms (kg).

次要结局

未报告次要终点

研究者

发起方
Poznan University of Physical Education
申办方类型
Other
责任方
Principal Investigator
主要研究者

Małgorzata Mizgier

Assistant Professor

Poznan University of Physical Education

研究点 (4)

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