Type 2 Diabetes Mellitus Clinical Trial
Official title:
Effects of Short-term Intensive Insulin Therapy on Long-term Complications in Patients With Type 2 Diabetes
Short-term intensive insulin therapy (SIIT) is able to reverse β cell dysfunction and induce
glycemic remission in patients with newly diagnosed type 2 diabetes. On the other hand,
intensive control of glucose and lifestyle modification are two key elements in preventing
chronic complications, especially microvascular neuropathy. However, no study reported the
long-term effect of SIIT on the chronic complications. In this multi-center, case-control
study, effects of SIIT on the proportion of long-term chronic complications as well as
potential biomarkers were investigated.
In total, 777 patients with type 2 diabetes, including 259 patients who participated SIIT
when diabetes was newly diagnosed and 518 patients who received routine diabetic therapy will
be enrolled in 12 centers in China. After baseline assessments, all patients will undergo
complications assessment, including records of cardiovascular diseases (CVD), carotid
ultrasonography, electrocardiogram, echocardiography, fundus photography, urinary albumin
excretion, Toronto Clinical Neuropathy Scale and Composite Autonomic Symptom Score. Primary
endpoint is the difference in the proportions of macrovascular and microvascular
complications between groups. Secondary endpoints include the difference of glucose control,
insulin resistance, complexity of anti-diabetic therapy and self-management skills and
quality of life between two groups. What's more, new biomarkers, which may indicate the
occurrence of chronic complications of diabetes, such as circulating endothelial progenitor,
β cell dysfunction, and T cells.
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