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

NCT01588743 | Unknown

• 1 other identifier: Prof. Li Guangwei
• Study Type: interventional
• Target: 130
• Locations: 0 countries
• Sites: N/A

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

Outcome Measures

Primary Outcomes (1)

• AUC75-120 of Glucose Infusion Rate (GIR)

  after 2 weeks insulin pump intensive therapy, and one-year follow-up after termination of treatments

Secondary Outcomes (1)

• AUC0-10 of Acute Insulin Response (AIR) during IVGTT

  after 2 weeks insulin pump intensive therapy, and one-year follow-up after termination of treatments

Interventions

insulin aspart DRUG

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.

Eligibility Criteria

• Age: 25 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Li Guangwei: lead

Related Publications (1)

• 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.

  PMID: 30629195 DERIVED

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Interventions

Insulin Aspart

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Insulin, Short-Acting; Insulins; Pancreatic Hormones; Peptide Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; Peptides; Amino Acids, Peptides, and Proteins

Study Officials

• Guangwei Li

  China-Japan Friendship Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: April 27, 2012
• First Posted: May 1, 2012
• Study Start: October 1, 2008
• Primary Completion: December 1, 2012
• Last Updated: May 1, 2012

Record last verified: 2012-04