NCT03909555

Effects of Short-term Intensive Insulin Therapy on Long-term Complications in Type 2 Diabetes

Effects of Short-term Intensive Insulin Therapy on Long-term Complications in Patients With Type 2 Diabetes

• Status: Unknown
• Phase: —
• Study type: Observational
• Enrollment: 777 (estimated)
• Sponsor: Sun Yat-sen University · Academic / Other
• Sex: All
• Age: 25 Years
• Healthy volunteers: Not accepted

Summary

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.

Conditions

• Type 2 Diabetes Mellitus

Interventions

Type	Name	Description
OTHER	Complications assessment	Records of cardiovascular diseases (CVD), carotid ultrasonography, electrocardiogram, echocardiography, fundus photography, urinary albumin excretion, Toronto Clinical Neuropathy Scale and Composite Autonomic Symptom Score.

Timeline

• Start date: 2019-06-01
• Primary completion: 2021-06-30
• Completion: 2021-12-31
• First posted: 2019-04-10
• Last updated: 2019-04-10

Locations

1 site across 1 country: China