Short-term Effect of Intensive Insulin Therapy on Incretin Secretion

May 10, 2010 updated by: The Catholic University of Korea
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.

Study Overview

Status

Completed

Conditions

Study Type

Observational

Enrollment (Anticipated)

30

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Korea, Republic of
      • Seoul, Korea, Republic of, 137-701
        • Division of Endocrinology and Metabolism, Kangnam St.Mary's Hospital
    • Kyonggi-do
      • Suwon, Kyonggi-do, Korea, Republic of, 442-723
        • Division of Endocrinology and Metabolism, St.Vincent's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

20 years to 70 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
wDM
Early diabetes
pDM
Poorly controlled diabetic patients

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Difference of incretin secretion before and after intensive insulin therapy
Time Frame: 2 months
2 months

Secondary Outcome Measures

Outcome Measure
Time Frame
Difference in incretin secretion according to the duration of diabetes
Time Frame: basal
basal
Factors affecting incretin secretion
Time Frame: basal
basal

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

The Catholic University of Korea

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

October 1, 2008

Primary Completion (ACTUAL)

December 1, 2009

Study Completion (ACTUAL)

December 1, 2009

Study Registration Dates

First Submitted

October 20, 2008

First Submitted That Met QC Criteria

October 20, 2008

First Posted (ESTIMATE)

October 21, 2008

Study Record Updates

Last Update Posted (ESTIMATE)

May 12, 2010

Last Update Submitted That Met QC Criteria

May 10, 2010

Last Verified

October 1, 2009

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • KCMC08MI168
  • VCMC08OT066

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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