Effects of Short-term Intensive Insulin Therapy in Newly Diagnosed Type 2 Diabetes Patients
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Purpose
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.
| Condition | Intervention |
|---|---|
|
Type 2 Diabetes Mellitus |
Drug: insulin aspart |
| Study Type: | Interventional |
| Study Design: | Intervention Model: Single Group Assignment Masking: Open Label Primary Purpose: Treatment |
| 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 |
- 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 ]
- 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: | 130 |
| Study Start Date: | October 2008 |
| Estimated Primary Completion Date: | December 2012 (Final data collection date for primary outcome measure) |
-
Drug: insulin aspart
Eligibility| Ages Eligible for Study: | 25 Years to 60 Years |
| Genders Eligible for Study: | Both |
| Accepts Healthy Volunteers: | No |
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.
Contacts and Locations More Information
No publications provided
| Responsible Party: | Li Guangwei, Professor, China-Japan Friendship Hospital |
| ClinicalTrials.gov Identifier: | NCT01588743 History of Changes |
| Other Study ID Numbers: | Prof. Li Guangwei |
| Study First Received: | April 27, 2012 |
| Last Updated: | April 30, 2012 |
| Health Authority: | China: Ethics Committee |
Additional relevant MeSH terms:
|
Diabetes Mellitus Diabetes Mellitus, Type 2 Glucose Metabolism Disorders Metabolic Diseases Endocrine System Diseases |
Insulin aspart Insulin Hypoglycemic Agents Physiological Effects of Drugs Pharmacologic Actions |
ClinicalTrials.gov processed this record on June 18, 2013