Ignite Creation Date:
2024-05-05 @ 11:49 AM
Last Modification Date:
2024-10-26 @ 9:14 AM
Study NCT ID:
NCT00147836
Status:
COMPLETED
Last Update Posted:
2008-04-01
First Post:
2005-09-04
Brief Title:
Evaluation of the Effects of Different Interventions on Glycemic Control in Newly-Diagnosed Type 2 Diabetic Patients
Sponsor:
Sun Yat-sen University
Organization:
Sun Yat-sen University
Study Overview
Official Title:
Evaluation of the Effects of Oral Anti-Hyperglycemic Agents Multiple Daily Injections or Continuous Subcutaneous Insulin Infusion on Glycemic Control B-Cell Function and the Remission Rate in Newly-Diagnosed Type 2 Diabetic Patients
Status:
COMPLETED
Status Verified Date:
2007-10
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:
The purpose of this study is to investigate and evaluate the effects of different interventions 1continuous subcutaneous insulin infusion2multiple daily injections 3anti-hyperglycemic agents on glycemic control B-cell function and the remission rate in newly-diagnosed type 2 diabetic patients
Detailed Description:
ß-Cell dysfunction and decreased insulin sensitivity are the main pathophysiological defects responsible for the development of hyperglycemia With continuous presence of insulin resistance progressive loss of ß-cell function is the crucial defect Hyperglycemia has deleterious effect on β-cell function which is partially reversible by adequate glycemic control In newly diagnosed type 2 diabetic patients with severe hyperglycemia 2 weeks continuous subcutaneous insulin infusion CSII can induce adequate glycemic control with improvement of β-cell function Nearly half of the patients can maintain euglycemia longer than 12 months by transient CSII The improvement of β-cell function especially the restoration of the first-phase insulin response is related to sustained euglycemia in the newly diagnosed type 2 diabetic patients But it is unclear whether any other interventions such as oral hypoglycemic agents and multiple daily injections inducing optimal glycemic control in a short period of time can have the same effect As a multicenter open-label randomized parallel-group study will be needed to further prove and clarify the findings
Study Oversight
Has Oversight DMC:
None
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?:
None
Secondary IDs
| Secondary ID | Type | Domain | Link |
|---|---|---|---|
| GSTB-05100981-LYB | None | None | None |