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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified April 2012 by China-Japan Friendship Hospital.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by (Responsible Party):
Li Guangwei, China-Japan Friendship Hospital
ClinicalTrials.gov Identifier:
NCT01588743
First received: April 27, 2012
Last updated: April 30, 2012
Last verified: April 2012
  Purpose

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 Intervention
Type 2 Diabetes Mellitus
Drug: insulin aspart

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: 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

Resource links provided by NLM:


Further study details as provided by China-Japan Friendship Hospital:

Primary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ] [ Designated as safety issue: No ]

Estimated Enrollment: 130
Study Start Date: October 2008
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
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.
  Eligibility

Ages Eligible for Study:   25 Years to 60 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01588743

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

No publications provided

Responsible Party: Li Guangwei, Professor, China-Japan Friendship Hospital
ClinicalTrials.gov Identifier: NCT01588743     History of Changes
Other Study ID Numbers: Prof. Li Guangwei
Study First Received: April 27, 2012
Last Updated: April 30, 2012
Health Authority: China: Ethics Committee

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

ClinicalTrials.gov processed this record on November 24, 2014