Functional Ovarian Hyperandrogenism/Minority Adolescents

描述(申请人提供)：功能性卵巢高雄激素血症 多囊卵巢综合征(FOH)，又称多囊卵巢综合征(PCOS) 伴随着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。生物化学 高雄激素血症和高雄激素血症的临床标准还没有 被确定为一个庞大的少数民族女性青少年人口。这个 研究的具体目的是：1)确定两者之间的关系 FOH/PCOS的临床表现和生化决定因素 以加勒比海裔西班牙裔和非裔美国人为主的临床样本 女青少年；2)建立女性青少年生化决定因素的标准 该人群中的高雄激素血症；3)确定临床相关性 青春期女孩的高雄激素血症；以及4)确定青春期 患有FOH/PCOS的女性比正常的、体重匹配的青少年更有可能 身为加勒比海裔西班牙裔，有糖尿病、高血压家族史 血压或心血管疾病，或有显著更高的血糖 胰岛素比率。假设如下：1)睾丸激素和 月经周期异常和/或月经周期异常患者的雄烯二酮水平 高雄激素症的物理证据将明显多于 月经周期正常且无体检证据的患者 高雄激素血症；2)临床和病史特征的结合可能是 用于开发可预测血清雄激素水平的模型；以及3) 患有FOH/PCOS的受试者比正常受试者更有可能发生 加勒比海-西班牙裔后裔，以获得糖尿病危险因素的证据 糖尿病和心血管疾病，并有显著更高的血糖 与胰岛素的比率。将连续招募250名年龄在12岁至21岁之间的女性 来自几个诊所；患有慢性病或正在服用激素的女孩 活性药物将被排除在外。受试者将完成一份问卷，以 有月经和家族史的特征，并将进行体检 检查以评估高雄激素血症的临床体征。血清水平 空腹游离和总睾酮，雄烯二酮，黄体生成素， 卵泡刺激素、胰岛素、17-羟孕酮和葡萄糖 量过了。探讨血清雄激素水平与临床的关系 FOH/PCOS的特点，所有受试者将在临床上分为三组 不同的类别和雄激素水平将在这些组中进行比较， 使用方差分析。高雄激素血症将被定义为以上两个标准差 正常人的平均睾酮和雄烯二酮水平 月经周期，没有高雄激素血症的身体证据(第一类)。 高雄激素血症的临床预测模型将使用 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 使用和不使用FOH/PCOS。提高对生化和生物化学的理解 少数民族青少年FOH/PCOS的临床特点有助于 早期治疗模式的发展和后期严重疾病的预防 这种疾病的自然发展所导致的健康问题。

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.