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Short-term Effect of Intensive Insulin Therapy on Incretin Secretion

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

Type 2 Diabetes

Study Type: Observational
Study Design: Observational Model: Case Control
Time Perspective: Prospective
Official Title: Short-term Effect of Intensive Insulin Therapy on Incretin Secretion

Resource links provided by NLM:

Further study details as provided by The Catholic University of Korea:

Primary Outcome Measures:
  • Difference of incretin secretion before and after intensive insulin therapy [ Time Frame: 2 months ]

Secondary Outcome Measures:
  • Difference in incretin secretion according to the duration of diabetes [ Time Frame: basal ]
  • Factors affecting incretin secretion [ Time Frame: basal ]

Biospecimen Retention:   Samples Without DNA
plasma serum

Estimated Enrollment: 30
Study Start Date: October 2008
Study Completion Date: December 2009
Primary Completion Date: December 2009 (Final data collection date for primary outcome measure)
Early diabetes
Poorly controlled diabetic patients


Ages Eligible for Study:   20 Years to 70 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
  1. Subjects with normal glucose tolerance
  2. Early diabetic patients with disease duration of less than 5years
  3. Uncontrolled diabetic patients

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
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Please refer to this study by its identifier: NCT00776243

Korea, Republic of
Division of Endocrinology and Metabolism, St.Vincent's Hospital
Suwon, Kyonggi-do, Korea, Republic of, 442-723
Division of Endocrinology and Metabolism, Kangnam St.Mary's Hospital
Seoul, Korea, Republic of, 137-701
Sponsors and Collaborators
The Catholic University of Korea
Principal Investigator: Kun-Ho Yoon, M.D., Ph.D. The Catholic University of Korea
  More Information