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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
  Purpose

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
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:

U.S. FDA Resources

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 ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • 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 ]

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)
Groups/Cohorts
wDM
Early diabetes
pDM
Poorly controlled diabetic patients

  Eligibility

Ages Eligible for Study:   20 Years to 70 Years
Genders Eligible for Study:   Both
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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: 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
  More Information

Publications:

Responsible Party: Kun-Ho Yoon, Kangnam St.Mary's hospital
ClinicalTrials.gov Identifier: NCT00776243     History of Changes
Other Study ID Numbers: KCMC08MI168, VCMC08OT066
Study First Received: October 20, 2008
Last Updated: May 10, 2010
Health Authority: South Korea: Institutional Review Board

Keywords provided by The Catholic University of Korea:
incretin
GLP-1
GIP
intensive insulin therapy

Additional relevant MeSH terms:
Diabetes Mellitus, Type 2
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Insulin
 Incretins
Hypoglycemic Agents
Physiological Effects of Drugs
Pharmacologic Actions
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists

ClinicalTrials.gov processed this record on May 23, 2013