Contraceptive in Women with Prior Gestational Diabetes

患有妊娠期糖尿病的女性的避孕措施

• 批准号: 6838235
• 负责人: ANNY H XIANG
• 金额: $ 16.25万
• 依托单位: UNIVERSITY OF SOUTHERN CALIFORNIA
• 依托单位国家: 美国
• 财政年份: 2004
• 资助国家: 美国
• 起止时间: 2004-01-01 至 2006-12-31
• 项目状态: 已结题
• 来源: https://reporter.nih.gov/project-details/6838235
• 关键词: Hispanic Americans; blood glucose; blood lipid; blood pressure; clinical research; diabetes risk; female; gestational diabetes mellitus; glucose tolerance; glucose tolerance test; high density lipoproteins; human data; hypertension; insulin sensitivity /resistance; low density lipoprotein; medroxyprogesterone; noninsulin dependent diabetes mellitus; oral contraceptives; triglycerides; women' s health

DESCRIPTION (provided by applicant): This application is submitted in response to PA-02-077, "Secondary Analyses in Diabetes, Digestive and Kidney Diseases". We propose to analyze data from an existing observational cohort database to assess the impact of different types of contraception on the risk of diabetes and on glucose levels, blood pressure and serum lipids in Latino women with prior gestational diabetes mellitus (GDM). We have previously shown that those women are at high risk of developing type 2 diabetes during their reproductive years. They require effective contraception because a) pregnancy planning is required to minimize the risk of conceiving with undetected hyperglycemia, which imparts a risk of congenital malformations to the baby and (b) additional pregnancies increase their risk of diabetes. Contraception should be safe regarding effects on glycemia and risk of diabetes, as well as on blood pressure and lipid levels, which can be elevated in association with the insulin resistance that is common in women with GDM. Using data from a subset of the current cohort available through 1994, we found that low-dose combination oral contraceptives (OCs) did not increase the risk of diabetes, but that a progestin-only oral preparation did increase that risk. Effects on lipids and blood pressure were not evaluated. Approximately 20% of hormonal contraception users in our patients elect to use an injectable progestin preparation, depomedroxyprogesterone acetate (DMPA) for long-term contraception. The impact of that preparation on the risk of diabetes is unknown. Accordingly, we now propose to use an expanded version of the cohort, including all patients through 1998 when accrual ended, to assess the impact of DMPA as compared to OCs and non-hormonal contraception, on the risk of diabetes and on glucose levels, blood pressure and lipid levels. Survival analysis will be use to compare diabetes rates among forms of contraception. Generalized linear models will be used to compare effects on glucose, blood pressure and lipid levels. Successful completion of these analyses will provide novel and clinically important information about the safety of several forms of hormonal contraception that are crucial for young Latino women at high risk for type 2 diabetes. The observational results will also be important to the design of future direct comparisons of different forms of contraception in this high-risk population.

描述(申请人提供)：本申请是针对PA-02-077“糖尿病、消化和肾脏疾病的二次分析”而提交的。我们建议分析现有观察队列数据库的数据，以评估不同类型的避孕措施对糖尿病风险以及对既往患有妊娠期糖尿病(GDM)的拉丁裔妇女的血糖水平、血压和血脂的影响。我们之前已经表明，这些妇女在生育期间患2型糖尿病的风险很高。她们需要有效的避孕措施，因为a)需要制定怀孕计划，以最大限度地降低怀孕时未发现的高血糖的风险，因为高血糖会给婴儿带来先天性畸形的风险，以及(B)额外怀孕会增加婴儿患糖尿病的风险。考虑到对血糖和糖尿病风险的影响，以及对血压和血脂水平的影响，避孕应该是安全的，这可能与妊娠期糖尿病妇女常见的胰岛素抵抗有关。使用截至1994年的现有队列的一个子集的数据，我们发现低剂量联合口服避孕药(OCS)不会增加糖尿病的风险，但仅服用孕激素的口服制剂确实会增加这种风险。没有评估对血脂和血压的影响。在我们的患者中，大约20%的激素避孕药使用者选择使用可注射孕激素制剂醋酸双孕酮(DMPA)进行长期避孕。该制剂对糖尿病风险的影响尚不清楚。因此，我们现在建议使用扩大版的队列，包括到1998年应计结束时的所有患者，以评估与口服避孕药和非激素避孕相比，DMPA对糖尿病风险以及对血糖水平、血压和血脂水平的影响。生存分析将用于比较不同避孕方式的糖尿病发病率。广义线性模型将用于比较对血糖、血压和血脂水平的影响。这些分析的成功完成将提供有关几种形式的荷尔蒙避孕药安全性的新的和临床上重要的信息，这些避孕药对患有2型糖尿病高危的年轻拉丁裔妇女至关重要。观察结果也将对未来在这一高危人群中对不同形式的避孕措施进行直接比较的设计具有重要意义。