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

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ClinicalTrials.gov Identifier: NCT01588743
Recruitment Status : Unknown
Verified April 2012 by Li Guangwei, China-Japan Friendship Hospital.
Recruitment status was:  Active, not recruiting
First Posted : May 1, 2012
Last Update Posted : May 1, 2012
Sponsor:
Information provided by (Responsible Party):

Study Description
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.

Condition or disease Intervention/treatment
Type 2 Diabetes Mellitus Drug: insulin aspart

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 130 participants
Intervention Model: Single Group Assignment
Masking: None (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
Study Start Date : October 2008
Estimated Primary Completion Date : December 2012

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arms and Interventions

Intervention Details:
    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.

Outcome Measures

Primary Outcome Measures :
  1. 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 ]

Secondary Outcome Measures :
  1. 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 ]

Eligibility Criteria

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Ages Eligible for Study:   25 Years to 60 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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.
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01588743


Sponsors and Collaborators
Li Guangwei
Investigators
Principal Investigator: Guangwei Li China-Japan Friendship Hospital
More Information

Responsible Party: Li Guangwei, Professor, China-Japan Friendship Hospital
ClinicalTrials.gov Identifier: NCT01588743     History of Changes
Other Study ID Numbers: Prof. Li Guangwei
First Posted: May 1, 2012    Key Record Dates
Last Update Posted: May 1, 2012
Last Verified: April 2012

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin, Globin Zinc
Insulin
Insulin Aspart
Hypoglycemic Agents
Physiological Effects of Drugs