Skip to main content
Clinical Trials/NCT01588743
NCT01588743
Unknown
Not Applicable

Effects of Short-term Intensive Insulin Therapy on Insulin Resistance and Insulin Secretion in Newly Diagnosed Lean and Obese Type 2 Diabetes Patients

Li Guangwei0 sites130 target enrollmentOctober 2008

Overview

Phase
Not Applicable
Intervention
Not specified
Conditions
Type 2 Diabetes Mellitus
Sponsor
Li Guangwei
Enrollment
130
Primary Endpoint
AUC75-120 of Glucose Infusion Rate (GIR)
Last Updated
14 years ago

Overview

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.

Registry
clinicaltrials.gov
Start Date
October 2008
End Date
December 2012
Last Updated
14 years ago
Study Type
Interventional
Study Design
Single Group
Sex
All

Investigators

Sponsor
Li Guangwei
Responsible Party
Sponsor Investigator
Principal Investigator

Li Guangwei

Professor

China-Japan Friendship Hospital

Eligibility Criteria

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.

Outcomes

Primary Outcomes

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

  • 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)

Similar Trials