Overview

This trial is active, not recruiting.

Condition type 2 diabetes mellitus
Treatment insulin aspart
Sponsor Li Guangwei
Start date October 2008
End date December 2012
Trial size 130 participants
Trial identifier NCT01588743, Prof. Li Guangwei

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.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Intervention model single group assignment
Masking open label
Primary purpose treatment

Primary Outcomes

Measure
AUC75-120 of Glucose Infusion Rate (GIR)
time frame: after 2 weeks insulin pump intensive therapy, and one-year follow-up after termination of treatments

Secondary Outcomes

Measure
AUC0-10 of Acute Insulin Response (AIR) during IVGTT
time frame: after 2 weeks insulin pump intensive therapy, and one-year follow-up after termination of treatments

Eligibility Criteria

Male or female participants from 25 years up to 60 years old.

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.

Additional Information

Official title Effects of Short-term Intensive Insulin Therapy on Insulin Resistance and Insulin Secretion in Newly Diagnosed Lean and Obese Type 2 Diabetes Patients
Principal investigator Guangwei Li
Trial information was received from ClinicalTrials.gov and was last updated in April 2012.
Information provided to ClinicalTrials.gov by China-Japan Friendship Hospital.