Diabetes Mellitus Clinical Trial
Official title:
A One-year Randomized Controlled Trial Evaluating the Impact of Pioglitazone Versus Linagliptin on Bone Turnover Markers
Diabetes mellitus is a common disease with much impact on human's health and is related to
osteoporosis. But the mechanism remains unclear. The foreign researches revealed
thiazolidinedione (TZD) would increase the risk of osteoporosis and bone fracture, specially
elderly women. However, it is still controversial in terms of the youth and men. In
Taiwan,there is few related study to analyze the relationship between TZD and steoporosis.
This is a multicenter randomized controlled study.
Diabetes mellitus is a common disease with much impact on human's health and is related to
osteoporosis. But the mechanism remains unclear. The foreign researches revealed
thiazolidinedione (TZD) would increase the risk of osteoporosis and bone fracture,
especially elderly women. However, it is still controversial in terms of the youth and men.
In Taiwan, there is few related study to analyze the relationship between TZD and
osteoporosis.
This is a multicenter randomized controlled study.This study will recruit adult (age ³40
years) type 2 diabetes patients who is on metformin (³1500mg/day) currently with recent
HbA1c between 7.0~8.5%.Patient who has history of macular edema, congestive heart failure
(NYHA Fc III, IV), chronic renal failure (stage IV, V), AST or ALT above 2.5 times upper
limit, Medical history of endocrinopathies, osteoporosis with bone fracture, cancer will be
excluded. Current bone fracture undergoing treatment, pregnancy, breast feeder will also be
excluded.
This is a 3-year project and will enroll 160 eligible volunteers who are to randomized into
group A and B (80 in each). During the next 48 weeks group A and B will receive
metformin+pioglitazone and metformin+linagliptin respectively. Blood sugar, renal, and liver
functions will be examined every 12 weeks. Calcium, phosphorus, vitamin D level, and bone
turnover markers (N-terminal propeptide of type 1 procollagen, bone-specific alkaline
phosphatase, osteocalcin, serum C- telopeptide, type 5 tartrate resistant acid phosphatase
(TRAP), pyridinoline and deoxypyridinoline crosslinks) will be checked each 6 months.
All the blood samples will be sent to one core laboratory center. The within-group
differences will be examined by repeated-measure ANOVA. The between-group differences will
be examined by Student's t test.
;
Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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