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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
Sponsor:
Information provided by:
The Catholic University of Korea

Brief Summary:
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.

Condition or disease
Type 2 Diabetes

Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Short-term Effect of Intensive Insulin Therapy on Incretin Secretion
Study Start Date : October 2008
Actual Primary Completion Date : December 2009
Actual Study Completion Date : December 2009

Resource links provided by the National Library of Medicine

Drug Information available for: Insulin
U.S. FDA Resources

Group/Cohort
wDM
Early diabetes
pDM
Poorly controlled diabetic patients



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

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

Biospecimen Retention:   Samples Without DNA
plasma serum


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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
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00776243


Locations
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
Investigators
Principal Investigator: Kun-Ho Yoon, M.D., Ph.D. The Catholic University of Korea