Effects of Short-term Intensive Insulin Therapy in Newly Diagnosed Type 2 Diabetes Patients

NCT ID: NCT01588743

Last Updated: 2012-05-01

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 130 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2008-10-31

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.

Conditions

Type 2 Diabetes Mellitus

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Interventions

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.

Intervention Type: DRUG

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.

• Minimum Eligible Age: 25 Years
• Maximum Eligible Age: 60 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Li Guangwei

OTHER

Sponsor Role: lead

Responsible Party

Li Guangwei

Professor

Responsibility Role: SPONSOR_INVESTIGATOR

Principal Investigators

Guangwei Li

Role: PRINCIPAL_INVESTIGATOR

China-Japan Friendship Hospital

References

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.

Reference Type: DERIVED

PMID: 30629195 (View on PubMed)

Other Identifiers

Prof. Li Guangwei

Identifier Type: -

Identifier Source: org_study_id