Bone material strength in normoglycemic and hyperglycemic adults

 描述(由申请人提供)：在2型糖尿病患者中，髋部和其他部位的骨折几乎增加了两倍，尽管他们的骨密度(BMD)比其他人高。这表明糖尿病患者骨密度以外的其他骨质量，包括骨材料强度(BMS)和骨小梁评分(TBS)都受到影响。大多数骨强度测量方法昂贵且不切实际，不适用于医疗保健环境或大型临床试验。因此，重要的是找出更实用的方法，用来研究高血糖对骨骼健康的影响，以及干预措施如何改善糖尿病患者的骨骼健康。这项拟议的项目评估了最近开发的骨质量指标BMS和TBS，因为它们与血糖有关。使用直接的临床测试来识别可能有糖尿病骨骼脆性风险的个人的能力将解决该领域的一个关键障碍，并将对与糖尿病相关的骨骼脆弱性的临床管理产生重大影响。拟议项目的总体目标是获得有关BMS和TBS的初步信息，它们是糖尿病前期和糖尿病患者骨折风险的潜在临床指标，并作为未来糖尿病干预临床试验的潜在结果指标。从拟议的研究中获得的信息预计将证明并促进将两种低成本、微创的骨质量指标作为主要或次要指标纳入旨在预防和治疗2型糖尿病及其包括骨折在内的后遗症的干预研究中。这项拟议的横断面研究调查了200名正常血糖、糖尿病前期和未经治疗的糖尿病患者的血糖和其他受试者特征与BMS和TBS的关系。非优势胫骨中段的BMS测量将使用微创手持式仪器进行测量。TBS将来自脊柱DXA扫描图像。其他测量包括同一胫骨中部部位和其他骨骼部位的骨密度扫描，以及通过问卷获得的其他身体测量和医疗和生活方式信息。一份空腹血样将分析HbA1c、血糖、血清肌酐和25-羟基维生素D，以及尿戊糖苷。分析将检查血糖状况、身体和生活方式特征与BMS和TBS的关系，并将检查这些测量在人口统计类别和糖尿病状况组中的差异。

 DESCRIPTION (provided by applicant): Fractures of the hip and other sites are increased nearly two-fold in patients with type 2 diabetes despite their having higher bone mineral density (BMD) than others. This suggests that bone qualities other than BMD, including bone material strength (BMS) and trabecular bone score (TBS), are compromised in diabetes. Most measurements of bone strength are expensive and impractical for use in health care settings or in large clinical trials. It is therefore important to identify more practical methods that can be used to investigate the effects of hyperglycemia on skeletal health and how interventions may improve skeletal health in diabetes. The proposed project evaluates recently developed measures of bone quality, BMS and TBS, as they relate to glycemia. The ability to use straightforward clinical tests to identify individuals who may be at risk for diabetic skeletal fragility would address a critical barrier in the field and would have major impact on clinical management of skeletal fragility associated with diabetes. The overall goal of the proposed project is to obtain preliminary information about BMS and TBS as potential clinical indicators of fracture risk among individuals with prediabetes and diabetes and as potential outcome measures in future clinical trials of diabetes interventions. Information gained from the proposed study is expected to justify and facilitate the inclusion of two low cost, minimally invasive measures of bone quality as primary or secondary measures in intervention studies designed to prevent and treat type two diabetes and its sequelae including fractures. The proposed cross-sectional study investigates associations of glycemia and other subject characteristics with BMS and TBS in 200 adults (age 50+) with normoglycemia, prediabetes and untreated diabetes. BMS measurement of the non-dominant anterior mid-tibia will be measured with a minimally invasive handheld instrument. TBS will be derived from spine DXA scan images. Other measurements include bone density scans of the same mid-tibial site and other skeletal sites, as well as other physical measurements and medical and lifestyle information obtained by questionnaire. One fasting blood sample will be analyzed for HbA1c, plasma glucose, serum creatinine and 25- hydroxyvitamin D, and urinary pentosidine. Analyses will examine associations of glycemic status, physical and lifestyle characteristics with BMS and TBS and will examine differences in these measures across demographic categories and diabetes status groups.