2015-08-012024-05-13https://scholars.lib.ntu.edu.tw/handle/123456789/650420摘要：糖尿病是一種全球普遍卻又對人體健康有著重大影響的疾病，與骨質疏鬆也有著密切的關係。但是其中機轉目前仍未清楚。Thiazolidinedione據國外研究顯示可能會造成老年女性骨鬆與骨折機率增加；但對青壯年或男性的影響目前仍無結論。而我國針對thiazolidinedione 影響骨代謝的相關研究更是缺乏。期能藉此研究進一步了解糖尿病及用藥對於骨骼系統所造成之影響及可能的病生理機轉。本計劃為多中心前瞻性研究（台大總院、新竹、雲林分院、亞東醫院），並將以隨機分配對照實驗的方式來進行。研究對象為年滿40 歲以上目前單獨使用metformin 控制已超過3 個月，且最近三個月糖化血色素為7.0~8.5%之第二型糖尿病病人。並排除黃斑部水腫、心衰竭（NYHA classIII~IV）、慢性腎病變(stage4~5)病人、孕婦、活動性肝病者（AST 或ALT大於正常上限之2.5 倍）、其他內分泌腺功能異常、骨質疏鬆併骨折病史或目前骨折正接受治療或癌症患者。本計劃為期3 年，預計將募集400 位符合條件之志願者進行研究。並以電腦隨機分為A、B 組各200 人。二組將分別使用metformin+pioglitazone或metformin+linagliptin 連續48 週。期間每12 週檢測一次血糖及肝、腎功能。每半年檢測鈣、磷離子濃度、副甲狀腺素、維生素D 及骨代謝指標(N-terminal propeptide of type 1 procollagen, bone-specific alkalinephosphatase, osteocalcin, serum C- telopeptide, type 5 tartrate resistant acidphosphatase (TRAP), pyridinoline and deoxypyridinoline crosslinks)。並在研究開始與結束接受橈骨，腰椎，髖骨的雙能量X 光吸收儀檢查。檢體將集中至一處檢驗中心檢測。研究結果將在調整相關干擾因子後以repeated-measure ANOVA、Student’s t test 來比較差異。<br> Abstract: Diabetes mellitus is a common disease with much impact on human’shealth and is related to osteoporosis. But the mechanism remains unclear. Theforeign researches revealed thiazolidinedione (TZD) would increase the risk ofosteoporosis and bone fracture, especially elderly women. However, it is stillcontroversial in terms of the youth and men. In Taiwan, there is few relatedstudy to analyze the relationship between TZD and osteoporosis.This is a multicenter (National Taiwan university hospital, Hsin-chu,Yun-lin branch, and Far east memorial hospital) randomized controlled study.This study will recruit adult (age ³40 years) type 2 diabetes patients who is onmetformin (³1500mg/day) currently with recent HbA1c between 7.0~8.5%.Patient who has history of macular edema, congestive heart failure (NYHA FcIII, IV), chronic renal failure (stage IV, V), AST or ALT above 2.5 times upperlimit, endocrinopathies, osteoporosis with bone fracure, cancer will be excluded.Current bone fracture undergoing treatment, pregnancy, breast feeder will alsobe excluded.This is a 3-year project and will enroll 400 eligible volunteers who are torandomized into group A and B (200 in each). During the next 48 weeks groupA and B will receive metformin+pioglitazone and metformin+linagliptinrespectively. Blood sugar, renal, and liver functions will be examined every 12weeks. Calcium, phosphorus, vitamin D level, and bone turnover markers(N-terminal propeptide of type 1 procollagen, bone-specific alkalinephosphatase, osteocalcin, serum C- telopeptide, type 5 tartrate resistant acidphosphatase (TRAP), pyridinoline and deoxypyridinoline crosslinks) will bechecked each 6 months. All the subjects will undergo dual-energy X-rayabsorptiometry (DXA) over hip, lumbar, and radius at week1 and week 48. Allthe blood samples will be sent to one core laboratory center.The within-group differences will be examined by repeated-measureANOVA. The between-group differences will be examined by Student’s t test.糖尿病愛妥糖糖漸平骨質疏鬆台灣多中心前瞻性研究thiazolidinedionediabetesosteoporosisbonerandomized control trialmulticenterpioglitazonelinagliptin