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

L

Li Guangwei

Status

Unknown

Conditions

Type 2 Diabetes Mellitus

Treatments

Drug: insulin aspart

Study type

Interventional

Funder types

Other

Identifiers

NCT01588743
Prof. Li Guangwei

Details and patient eligibility

About

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.

Enrollment

130 estimated patients

Sex

All

Ages

25 to 60 years old

Volunteers

No Healthy Volunteers

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.

Trial design

Primary purpose

Treatment

Allocation

N/A

Interventional model

Single Group Assignment

Masking

None (Open label)

Trial contacts and locations

0

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Data sourced from clinicaltrials.gov

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