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Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT01588743
Other study ID # Prof. Li Guangwei
Secondary ID
Status Active, not recruiting
Phase N/A
First received April 27, 2012
Last updated April 30, 2012
Start date October 2008

Study information

Verified date April 2012
Source China-Japan Friendship Hospital
Contact n/a
Is FDA regulated No
Health authority China: Ethics Committee
Study type Interventional

Clinical Trial 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.


Recruitment information / eligibility

Status Active, not recruiting
Enrollment 130
Est. completion date
Est. primary completion date December 2012
Accepts healthy volunteers No
Gender Both
Age group 25 Years to 60 Years
Eligibility 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

Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Drug:
insulin aspart
Insulin Aspart will be administrated by insulin pump with an initial dose of 0.4-0.6u/kg body weight, of which 50% basal rate and the other 50% bolus dose. Time interval for administration will be as follows: 0-3Am-9Am-12Am-5Pm-9Pm-0Am. Specific adjustment will be made according to individual difference.

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Li Guangwei

Outcome

Type Measure Description Time frame Safety issue
Primary AUC75-120 of Glucose Infusion Rate (GIR) after 2 weeks insulin pump intensive therapy, and one-year follow-up after termination of treatments No
Secondary 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 No
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