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

Primary Purpose

Type 2 Diabetes Mellitus

Status
Unknown status
Phase
Not Applicable
Locations
Study Type
Interventional
Intervention
insulin aspart
Sponsored by
Li Guangwei
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an interventional treatment trial for Type 2 Diabetes Mellitus

Eligibility Criteria

25 Years - 60 Years (Adult)All SexesDoes not accept 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.

Sites / Locations

    Outcomes

    Primary Outcome Measures

    AUC75-120 of Glucose Infusion Rate (GIR)

    Secondary Outcome Measures

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

    Full Information

    First Posted
    April 27, 2012
    Last Updated
    April 30, 2012
    Sponsor
    Li Guangwei
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    1. Study Identification

    Unique Protocol Identification Number
    NCT01588743
    Brief Title
    Effects of Short-term Intensive Insulin Therapy in Newly Diagnosed Type 2 Diabetes Patients
    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 Type
    Interventional

    2. Study Status

    Record Verification Date
    April 2012
    Overall Recruitment Status
    Unknown status
    Study Start Date
    October 2008 (undefined)
    Primary Completion Date
    December 2012 (Anticipated)
    Study Completion Date
    undefined (undefined)

    3. Sponsor/Collaborators

    Responsible Party, by Official Title
    Sponsor-Investigator
    Name of the Sponsor
    Li Guangwei

    4. Oversight

    5. 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.

    6. Conditions and Keywords

    Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
    Type 2 Diabetes Mellitus

    7. Study Design

    Primary Purpose
    Treatment
    Study Phase
    Not Applicable
    Interventional Study Model
    Single Group Assignment
    Masking
    None (Open Label)
    Allocation
    N/A
    Enrollment
    130 (Anticipated)

    8. Arms, Groups, and Interventions

    Intervention Type
    Drug
    Intervention Name(s)
    insulin aspart
    Intervention Description
    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.
    Primary Outcome Measure Information:
    Title
    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 Measure Information:
    Title
    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

    10. Eligibility

    Sex
    All
    Minimum Age & Unit of Time
    25 Years
    Maximum Age & Unit of Time
    60 Years
    Accepts Healthy Volunteers
    No
    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.
    Overall Study Officials:
    First Name & Middle Initial & Last Name & Degree
    Guangwei Li
    Organizational Affiliation
    China-Japan Friendship Hospital
    Official's Role
    Principal Investigator

    12. IPD Sharing Statement

    Citations:
    PubMed Identifier
    30629195
    Citation
    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.
    Results Reference
    derived

    Learn more about this trial

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

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