Functional Ovarian Hyperandrogenism/Minority Adolescents

功能性卵巢雄激素过多症/少数民族青少年

• 批准号: 6359233
• 负责人: JESSICA RIEDER
• 金额: $ 6.99万
• 依托单位: MONTEFIORE MEDICAL CENTER (BRONX, NY)
• 依托单位国家: 美国
• 财政年份: 2001
• 资助国家: 美国
• 起止时间: 2001-08-01 至 2003-07-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6359233
• 关键词: African American; Caribbean; adolescence (12-20); adrenal disorder; androstenedione; biochemistry; cardiovascular disorder; clinical research; comorbidity; diabetes mellitus; diagnosis design /evaluation; disease /disorder proneness /risk; early diagnosis; ethnic group; female; female reproductive system disorder diagnosis; human subject; mathematical model; menstrual cycle disorder; model design /development; pathologic process; polycystic ovary syndrome; questionnaires; racial /ethnic difference; serology /serodiagnosis; testosterone; women's health

DESCRIPTION (provided by applicant): Functional Ovarian Hyperandrogenism (FOH), also called Polycystic Ovarian Syndrome (PCOS) consists of a spectrum of dysfunction with varying degrees of ovulatory dysfunction, hyperandrogenemia, and clinically evident hyperandrogenism. The biochemical and clinical criteria for hyperandrogenemia and hyperandrogenism have not yet been determined for a large ethnic minority female adolescent population. The specific aims of the study are: 1) to determine the relationship between the clinical presentation and the biochemical determinants of FOH/PCOS in a clinical sample of predominantly Caribbean-Hispanic and African-American female adolescents; 2) to establish norms for the biochemical determinants of hyperandrogenemia in this population; 3) to determine the clinical correlates of hyperandrogenemia in adolescent girls; and 4) to determine if adolescent females with FOH/PCOS are more likely than normal, weight-matched adolescents to be Caribbean-Hispanic, to have a family history of diabetes, high blood pressure or cardiovascular disease, or to have significantly higher glucose to insulin ratios. The hypotheses are as follows: 1) the testosterone and androstenedione levels in subjects with menstrual cycle abnormalities and/or physical evidence of hyperandrogenism will be significantly greater than in those with normal menstrual cycles and no physical evidence for hyperandrogenism; 2) a combination of clinical and historical features may be used to develop a model that can predict serum androgen levels; and 3) subjects with FOH/PCOS will be more likely than normal subjects to be of Caribbean-Hispanic descent, to have evidence of risk factors for diabetes mellitus and cardiovascular disease, and to have significantly higher glucose to insulin ratios. 250 females aged 12 to 21 will be consecutively recruited from several clinical sites; girls with chronic illnesses or on hormonally active drugs will be excluded. Subjects will complete a questionnaire to elicit features of menstrual and family history and will undergo a physical examination to evaluate for clinical signs of hyperandrogenism. Serum levels of fasting free and total testosterone, androstenedione, luteinizing hormone, follicle stimulating hormone, insulin, 17-OH progesterone, and glucose will be measured. To determine the association of serum androgen levels with clinical features of FOH/PCOS, all subjects will be clinically stratified into three different categories and androgen levels will be compared among these groups, using ANOVA. Hyperandrogenism will be defined as two standard deviations above the mean testosterone and androstenedione levels in subjects with normal menstrual cycles and no physical evidence of hyperandrogenism (category I). A clinical prediction model for hyperandrogenemia will be developed using multiple linear regression analyses for androgen measures. A case-control study will be performed to determine differences between adolescent subjects with and without FOH/PCOS. Improved understanding of the boichemical and clinical features of FOH/PCOS in minority adolescents will facilitate the development of earlier treatment modalities and prevention of later serious health problems that result from the natural progression of this disorder.

描述（由申请人提供）：功能性卵巢雄激素过多症 (FOH)，也称为多囊卵巢综合症 (PCOS)，由一系列频谱组成 不同程度的排卵功能障碍， 高雄激素血症和临床明显的高雄激素血症。生化 高雄激素血症和高雄激素血症的临床标准尚未制定 是针对大量少数民族女性青少年人口确定的。这 研究的具体目的是：1）确定 FOH/PCOS 的临床表现和生化决定因素 主要是加勒比裔西班牙裔和非裔美国人的临床样本 女性青少年； 2）建立生化决定因素的标准 该人群的高雄激素血症； 3) 确定临床相关性 青春期女孩的高雄激素血症； 4) 确定是否处于青春期 女性患有 FOH/PCOS 的可能性比正常体重匹配的青少年高 加勒比裔西班牙裔，有糖尿病、高血压家族史 压力或心血管疾病，或血糖明显升高 胰岛素比率。假设如下：1）睾酮和 月经周期异常和/或受试者的雄烯二酮水平 高雄激素血症的物理证据将明显多于 那些月经周期正常且没有任何物理证据的人 雄激素过多症; 2）临床和历史特征的结合可能是 用于开发可以预测血清雄激素水平的模型；和 3) 患有 FOH/PCOS 的受试者比正常受试者更有可能出现 加勒比裔西班牙裔血统，有糖尿病危险因素的证据 糖尿病和心血管疾病，并且血糖明显升高 与胰岛素的比例。连续招募250名12岁至21岁女性 来自多个临床中心；患有慢性疾病或服用荷尔蒙的女孩 活性药物将被排除在外。受试者将完成一份调查问卷 引出月经和家族史的特征，并将接受身体检查 检查以评估雄激素过多症的临床症状。血清水平 空腹游离睾酮和总睾酮、雄烯二酮、黄体生成素、 卵泡刺激素、胰岛素、17-OH黄体酮和葡萄糖 测量。确定血清雄激素水平与临床的关系 根据 FOH/PCOS 的特征，所有受试者将在临床上分为三级 将在这些组之间比较不同的类别和雄激素水平， 使用方差分析。高雄激素血症将被定义为以上两个标准差 正常受试者的平均睾酮和雄烯二酮水平 月经周期，无雄激素过多症的物理证据（I 类）。 将使用以下方法开发高雄激素血症的临床预测模型 雄激素测量的多元线性回归分析。病例对照 将进行研究以确定青少年受试者之间的差异 有或没有 FOH/PCOS。加深对生物化学和 少数民族青少年 FOH/PCOS 的临床特征将有助于 开发早期治疗方式并预防后期严重的 由于这种疾病的自然进展而导致的健康问题。