Effects of Short-term Intensive Insulin Therapy in Newly Diagnosed Type 2 Diabetes Patients
Primary Purpose
Type 2 Diabetes Mellitus
Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
insulin aspart
Sponsored by
About this trial
This is an interventional treatment trial for Type 2 Diabetes Mellitus
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.
Sites / Locations
Outcomes
Primary Outcome Measures
AUC75-120 of Glucose Infusion Rate (GIR)
Secondary Outcome Measures
AUC0-10 of Acute Insulin Response (AIR) during IVGTT
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01588743
Brief Title
Effects of Short-term Intensive Insulin Therapy in Newly Diagnosed Type 2 Diabetes Patients
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
Study Type
Interventional
2. Study Status
Record Verification Date
April 2012
Overall Recruitment Status
Unknown status
Study Start Date
October 2008 (undefined)
Primary Completion Date
December 2012 (Anticipated)
Study Completion Date
undefined (undefined)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Li Guangwei
4. Oversight
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Type 2 Diabetes Mellitus
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
130 (Anticipated)
8. Arms, Groups, and Interventions
Intervention Type
Drug
Intervention Name(s)
insulin aspart
Intervention Description
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.
Primary Outcome Measure Information:
Title
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 Outcome Measure Information:
Title
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
10. Eligibility
Sex
All
Minimum Age & Unit of Time
25 Years
Maximum Age & Unit of Time
60 Years
Accepts Healthy Volunteers
No
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Guangwei Li
Organizational Affiliation
China-Japan Friendship Hospital
Official's Role
Principal Investigator
12. IPD Sharing Statement
Citations:
PubMed Identifier
30629195
Citation
Wang H, Kuang J, Xu M, Gao Z, Li Q, Liu S, Zhang F, Yu Y, Liang Z, Zhao W, Yang G, Li L, Wang Y, Li G. Predictors of Long-Term Glycemic Remission After 2-Week Intensive Insulin Treatment in Newly Diagnosed Type 2 Diabetes. J Clin Endocrinol Metab. 2019 Jun 1;104(6):2153-2162. doi: 10.1210/jc.2018-01468.
Results Reference
derived
Learn more about this trial
Effects of Short-term Intensive Insulin Therapy in Newly Diagnosed Type 2 Diabetes Patients
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