Effects of Short-term Intensive Insulin Therapy in Newly Diagnosed Type 2 Diabetes Patients

Not Applicable

• Conditions: Type 2 Diabetes Mellitus

• Registration Number: NCT01588743
• Lead Sponsor: Li Guangwei

Brief Summary

It is well known that Long-term hyperglycemia (also known as glucose toxicity) contribute to impairment in islet β-cell function and development of insulin resistance. A growing body of evidence also indicates that this impairment inβ-cell function and insulin action could be restored after hyperglycemia is corrected by short-term intensive insulin therapy. In this study, we are determined to use the golden standard of insulin sensitivity evaluation in vivo-hyperinsulinemia euglycemic glucose clamp-to estimate insulin resistance improvement in patients before and after intensive insulin therapy, investigate first phase insulin secretion to evaluate β-cell function, examine the changes in insulin resistance and insulin secretion resulting from normalization of plasma glucose levels in both lean and obese patients by insulin pump therapy.

Detailed Description

Not available

Study Timeline

• Study Start: 2008-10
• Status Verified: 2012-04
• Study First Submitted: 2012-04-27
• Study First Submitted QC: 2012-04-30
• Last Update Submitted: 2012-04-30
• Study First Posted: 2012-05-01
• Last Update Posted: 2012-05-01
• Primary Completion: 2012-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 130

Inclusion Criteria

• Age: 25 to 60 years old
• Duration of diabetes: newly diagnosed type 2 diabetes (duration of diabetes less than 1 year) and haven't taken any antidiabetic medication.
• Fasting blood glucose is above 11.0mmol/L.
• Half of the patients with BMI below 24 and the other half with BMI above 24.

Exclusion Criteria

• type 1 diabetes mellitus
• type 2 diabetes patients with intercurrent illness (ketoacidosis, infection or any other acute stress)
• Presence of auto-immune disease, hepatic or renal disease or any concomitant disease is not allowed.
• Women who are pregnant, breast feeding or have the intention of becoming pregnant within next 12 months.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Primary Outcome Measures

Name	Time	Method
AUC75-120 of Glucose Infusion Rate (GIR)	after 2 weeks insulin pump intensive therapy, and one-year follow-up after termination of treatments

Secondary Outcome Measures

Name	Time	Method
AUC0-10 of Acute Insulin Response (AIR) during IVGTT	after 2 weeks insulin pump intensive therapy, and one-year follow-up after termination of treatments