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Short-term Effect of Intensive Insulin Therapy on Incretin Secretion

This study has been completed.
Sponsor:
Information provided by:
The Catholic University of Korea
ClinicalTrials.gov Identifier:
NCT00776243
First received: October 20, 2008
Last updated: May 10, 2010
Last verified: October 2009
History of Changes

October 20, 2008
May 10, 2010
October 2008
December 2009   (final data collection date for primary outcome measure)
Difference of incretin secretion before and after intensive insulin therapy [ Time Frame: 2 months ] [ Designated as safety issue: No ]
Same as current
Complete list of historical versions of study NCT00776243 on ClinicalTrials.gov Archive Site
  • Difference in incretin secretion according to the duration of diabetes [ Time Frame: basal ] [ Designated as safety issue: No ]
  • Factors affecting incretin secretion [ Time Frame: basal ] [ Designated as safety issue: No ]
Same as current
Not Provided
Not Provided
 
Short-term Effect of Intensive Insulin Therapy on Incretin Secretion
Short-term Effect of Intensive Insulin Therapy on Incretin Secretion

In type 2 diabetic patients, abnormality in secretion or action of incretin(GLP-1, GIP) is observed. Although controversy still exists, the secretion of GLP-1 is thought to be reduced by 20-30% while GIP secretion is normal or slightly elevated, in type 2 diabetic patients. Various parameters such as the duration of diabetes, the amount of meal and their constitution, gastric bypass surgery, and some antidiabetic drugs affect the secretion of incretin. However, the secretion of GLP-1 and GIP in glucotoxic condition and whether they recover after improvement of glycemic status is not known. The investigators aim to study the effect of intensive insulin treatment in uncontrolled diabetic patients.
Not Provided
Observational
Observational Model: Case Control
Time Perspective: Prospective
Not Provided
Retention:   Samples Without DNA
Description:

plasma serum
Non-Probability Sample
  1. Subjects with normal glucose tolerance
  2. Early diabetic patients with disease duration of less than 5years
  3. Uncontrolled diabetic patients
Type 2 Diabetes
Not Provided
  • wDM
    Early diabetes
  • pDM
    Poorly controlled diabetic patients

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Completed
30
December 2009
December 2009   (final data collection date for primary outcome measure)

Inclusion Criteria:

  • type 2 diabetic patients with disease duration of less than 15years
  • age of 20-70 years
  • BMI 22-27
  • HbA1c 9-13%
  • patients willing to receive intensive glucose control

  • patients who are able to monitor their glucose level at home

    • for normal glucose tolerance group : NGT subjects with same range of age and BMI
    • for early diabetes group : patients with diabetic duration of less than 5 years and HbA1c level less than 7.5% for at least last 6 months

Exclusion Criteria:

  • previous history of insulin treatment
  • patients taking alpha-glucosidase inhibitor or thiazolidinedione
  • serum creatinine >= 1.5 mg/dL
  • hemoglobin < 10 g/dL
  • AST/ALT greater than 3 times normal range
  • ischemic heart disease, congestive heart failure (NYHA grade >=2)
  • chronic renal failure, proliferative diabetic retinopathy, CVA
  • patients with gastroparesis or taking medications altering gastric motility
  • usage of steroid or other agents affecting glucose metabolism
  • pregnant or breast-feeding women
Both
20 Years to 70 Years
Yes
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
 
NCT00776243
KCMC08MI168, VCMC08OT066
No
Kun-Ho Yoon, Kangnam St.Mary's hospital
The Catholic University of Korea
Not Provided
Principal Investigator: Kun-Ho Yoon, M.D., Ph.D. The Catholic University of Korea
The Catholic University of Korea
October 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP