Effects of Short-term Intensive Insulin Therapy in Newly Diagnosed Type 2 Diabetes Patients
This study is ongoing, but not recruiting participants.
Information provided by (Responsible Party):
Li Guangwei, China-Japan Friendship Hospital
First received: April 27, 2012
Last updated: April 30, 2012
Last verified: April 2012
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.
Type 2 Diabetes Mellitus
Drug: insulin aspart
||Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
||Effects of Short-term Intensive Insulin Therapy on Insulin Resistance and Insulin Secretion in Newly Diagnosed Lean and Obese Type 2 Diabetes Patients
Primary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]
Secondary Outcome Measures:
- 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 ] [ Designated as safety issue: No ]
| Estimated Enrollment:
| Study Start Date:
| Estimated Primary Completion Date:
||December 2012 (Final data collection date for primary outcome measure)
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.
|Ages Eligible for Study:
||25 Years to 60 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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.
- 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.
Please refer to this study by its ClinicalTrials.gov identifier: NCT01588743
||China-Japan Friendship Hospital
No publications provided
||Li Guangwei, Professor, China-Japan Friendship Hospital
History of Changes
|Other Study ID Numbers:
||Prof. Li Guangwei
|Study First Received:
||April 27, 2012
||April 30, 2012
||China: Ethics Committee
Additional relevant MeSH terms:
ClinicalTrials.gov processed this record on June 18, 2013
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Endocrine System Diseases
Physiological Effects of Drugs