Ignite Creation Date:
2025-12-25 @ 1:47 AM
Ignite Modification Date:
2026-02-25 @ 9:48 PM
Study NCT ID:
NCT00506194
Status:
COMPLETED
Last Update Posted:
2013-10-01
First Post:
2007-07-24
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Short-Term Intensive Insulin Therapy Induction of Long-term Glycemic Control
Sponsor:
Taipei Veterans General Hospital, Taiwan
Organization:
Study Overview
Official Title:
Short-Term Intensive Insulin Therapy Induction of Long-term Glycemic Control Is Associated With Improvement of ß-Cell Function in Newly Diagnosed Type 2 Diabetic Patients
Status:
COMPLETED
Status Verified Date:
2013-09
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
We designed this prospective, randomized control study to compare the benefits between the insulin therapy and OADs after correction of the glucose toxicity with a short period of intensive insulin therapy.
Detailed Description:
OBJECTIVE-Type 2 diabetes is associated with defects in insulin secretion and insulin action. Hyperglycemia may aggravate these defects, a feature known as glucose toxicity. Previous studies have shown that acute correction of hyperglycemia in subjects with long-standing type 2 diabetes gives only short-term improvement in glycemic control after discontinuation of insulin. The current study attempts to identify any characteristics of patients with newly diagnosed type 2 diabetes (fasting glucose \>300mg/dL) who would have a long-term benefit, in terms of glycemic control, from a brief course of insulin therapy.
RESEARCH DESIGN AND METHODS-Newly diagnosed type 2 diabetic patients with severe hyperglycemia (fasting blood glucose \>300 mg/dL or random blood glucose \>400 mg/dL) will be hospitalized and treated with intensive insulin injection for 10 to 14 days. Oral glucose tolerance will be performed after one week of intensive insulin treatment. After discharge, patients will be randomized to receive insulin injection or oral anti-diabetic drug for further management. Patients will be followed in our clinics and adjust their medication according to their blood glucose levels. Oral glucose tolerance test will be repeated 6 months later, whereas the insulin sensitivity and beta-cell function will be evaluated again.
EXPECTED RESULTS-We will respect that short-term intensive insulin therapy can induce lone-term glycemic control in newly diagnosed type 2 diabetes with severe hyperglycemia.
RESEARCH DESIGN AND METHODS-Newly diagnosed type 2 diabetic patients with severe hyperglycemia (fasting blood glucose \>300 mg/dL or random blood glucose \>400 mg/dL) will be hospitalized and treated with intensive insulin injection for 10 to 14 days. Oral glucose tolerance will be performed after one week of intensive insulin treatment. After discharge, patients will be randomized to receive insulin injection or oral anti-diabetic drug for further management. Patients will be followed in our clinics and adjust their medication according to their blood glucose levels. Oral glucose tolerance test will be repeated 6 months later, whereas the insulin sensitivity and beta-cell function will be evaluated again.
EXPECTED RESULTS-We will respect that short-term intensive insulin therapy can induce lone-term glycemic control in newly diagnosed type 2 diabetes with severe hyperglycemia.
Study Oversight
Has Oversight DMC:
True
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: