Hearing Impairment in Long-Term Type 1 Diabetes

描述(申请人提供)：DCCT/EDIC研究的主要任务是确定血糖控制和非高血糖风险因素对1型糖尿病并发症的影响。1型糖尿病患者的听力损失患病率可能比可比的非糖尿病患者更高。听力损失是否会因现在或过去的血糖控制程度或其他糖尿病并发症的存在而改变，目前尚不清楚。DCCT/EDIC队列提供了一个很好的机会来描述1型糖尿病患者的听力损害，因为它对队列进行了长期的跟踪(30年)。我们建议使用听力问卷和纯音测听测试来确定整个DCCT/EDIC队列的听力，并与大约260名非糖尿病患者的类似评估结果进行比较，我们预计1350名幸存的EDIC志愿者中至少有1100人将自愿参加。每个诊所都将发放一份听证问卷。每个诊所将进行标准化的纯音测听测试。主要结果是基于500、1000、2000和4000赫兹纯音阈值平均值的听力损害患病率。听力障碍将被定义为平均超过25分贝的纯音。这项建议的具体目的是：1)基于自填式问卷和不同频率下的气导纯音阈值测量，确定DCCT/EDIC队列中的听力损害是否比没有糖尿病的对照组更普遍；2)通过DCCT/EDIC研究约30年的平均A1C测量，评估高血糖与听力损害的患病率和程度的相关性；3)确定DCCT强化治疗组与常规治疗组之间听力损害的患病率和程度是否不同；以及4)评估其他决定因素(例如，人口统计、临床状态、生化参数、行为特征和环境)是否与DCCT/EDIC队列中听力障碍的患病率和程度有关。上述方案将具有超过90%的能力来检测控制组和DCCT/EDIC志愿者之间听力损失几率的两倍差异。这些结果将确定1型糖尿病患者与非糖尿病对照组相比的听力能力、血糖控制的影响、其他糖尿病并发症对听力的影响，以及听力障碍风险因素(人口、临床、生化、行为和环境)的识别。我们预计，这些数据将导致听力筛查和测试建议，这将对所有1型糖尿病患者的生活质量和健康产生重大影响。

DESCRIPTION (provided by applicant): The primary mission of the DCCT/EDIC study is to determine the effects of glycemic control and of non- hyperglycemic risk factors on the complications of type 1 diabetes. Persons with type 1 diabetes may have a greater prevalence of hearing loss than comparable non-diabetic individuals. Whether hearing loss is altered by the degree of present or past glucose control or the presence of other diabetes complications is unknown. The DCCT/EDIC cohort provides an excellent opportunity to characterize hearing impairment in type 1 diabetes owing to its long term follow-up of the cohort (30 years). We propose to utilize both a hearing questionnaire and pure tone audiometry testing to define the auditory capability of the entire DCCT/EDIC cohort, to be compared with the results of like assessments in a comparable group of approximately 260 individuals without diabetes, We anticipate that at least 1,100 of the 1,350 surviving EDIC volunteers will volunteer. A hearing questionnaire will be administered by each clinic. Standardized pure tone audiometry testing will be done by each clinic. The primary outcome is the prevalence of hearing impairment based on a mean of the pure tone average of thresholds at 500, 1000, 2000, and 4000 Hz. Hearing impairment will be defined as a pure tone average greater than 25 dB. The Specific Aims of this proposal are: 1) To determine whether hearing impairment, based on both self-administered questionnaire and measurement of air conduction pure tone thresholds at various frequencies, is more prevalent in the DCCT/EDIC cohort than in a control group without diabetes; 2) To assess the association of hyperglycemia, as measured by the mean A1C over ~30 years of the DCCT/EDIC study, with the prevalence and extent of hearing impairment; 3) To determine whether the prevalence and extent of hearing impairment differs between the prior DCCT intensive treatment group versus the conventional treatment groups; and 4) To evaluate whether other determinants (e.g., demographic, clinical status, biochemical parameters, behavioral characteristics, and environmental) are related to the prevalence and extent of hearing impairment in the DCCT/EDIC cohort. The above protocol will have greater than 90% power to detect a two-fold difference in the odds of having a hearing loss between the controls and the DCCT/EDIC volunteers. The results will establish the hearing capabilities of individuals with type 1 diabetes compared to non diabetic controls, the impact of glycemic control, the presence of other diabetic complications on hearing, and the identification of hearing impairment risk factors (demographic, clinical, biochemical, behavioral, and environmental). We anticipate that these data will lead to audiological screening and testing recommendations that will have a major quality of life health benefit for all individuals with type 1 diabetes.