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

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

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.

Sponsors & Collaborators

• Guangdong Provincial People's Hospital

  collaborator OTHER

• Zhujiang Hospital

  collaborator OTHER

• The Third Affiliated Hospital of Guangzhou Medical University

  collaborator OTHER

• The Third Affiliated Hospital of Southern Medical University

  collaborator OTHER_GOV

• Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University

  collaborator OTHER

• The First Affiliated Hospital of Guangzhou Medical University

  collaborator OTHER

• Nanfang Hospital, Southern Medical University

  collaborator OTHER

• First Affiliated Hospital of Jinan University

  collaborator OTHER

• Guangzhou Red Cross Hospital

  collaborator OTHER

• Dongguan Kanghua Hospital

  collaborator OTHER

• Sun Yat-sen University

  lead OTHER

Eligibility

Min Age

25 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2019-06-01

Primary Completion

2021-06-30

Completion

2021-12-31

Countries

• China

Study Locations