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Short-term Effect of Intensive Insulin Therapy on Incretin Secretion

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ClinicalTrials.gov Identifier: NCT00776243
Recruitment Status : Completed
First Posted : October 21, 2008
Last Update Posted : May 12, 2010
Information provided by:
The Catholic University of Korea

October 20, 2008
October 21, 2008
May 12, 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 ]
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 ]
  • Factors affecting incretin secretion [ Time Frame: basal ]
Same as current
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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.
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Observational Model: Case Control
Time Perspective: Prospective
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Retention:   Samples Without DNA
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
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  • 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.
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
Sexes Eligible for Study: All
20 Years to 70 Years   (Adult, Senior)
Contact information is only displayed when the study is recruiting subjects
Korea, Republic of
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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