- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01588743
Effects of Short-term Intensive Insulin Therapy in Newly Diagnosed Type 2 Diabetes Patients
April 30, 2012 updated by: Li Guangwei
Effects of Short-term Intensive Insulin Therapy on Insulin Resistance and Insulin Secretion in Newly Diagnosed Lean and Obese Type 2 Diabetes Patients
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.
Study Overview
Study Type
Interventional
Enrollment (Anticipated)
130
Phase
- Not Applicable
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
25 years to 60 years (Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: N/A
- Interventional Model: Single Group Assignment
- Masking: None (Open Label)
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
after 2 weeks insulin pump intensive therapy, and one-year follow-up after termination of treatments
|
Secondary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
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
|
after 2 weeks insulin pump intensive therapy, and one-year follow-up after termination of treatments
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Investigators
- Principal Investigator: Guangwei Li, China-Japan Friendship Hospital
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
October 1, 2008
Primary Completion (Anticipated)
December 1, 2012
Study Registration Dates
First Submitted
April 27, 2012
First Submitted That Met QC Criteria
April 30, 2012
First Posted (Estimate)
May 1, 2012
Study Record Updates
Last Update Posted (Estimate)
May 1, 2012
Last Update Submitted That Met QC Criteria
April 30, 2012
Last Verified
April 1, 2012
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- Prof. Li Guangwei
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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