Short-term Effect of Intensive Insulin Therapy on Incretin Secretion

NCT ID: NCT00776243

Last Updated: 2010-05-12

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2008-10-31

Study Completion Date

2009-12-31

Brief Summary

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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.

Detailed Description

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Conditions

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Type 2 Diabetes

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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wDM

Early diabetes

No interventions assigned to this group

pDM

Poorly controlled diabetic patients

No interventions assigned to this group

Eligibility Criteria

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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
Minimum Eligible Age

20 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes

Sponsors

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The Catholic University of Korea

OTHER

Sponsor Role lead

Responsible Party

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Kangnam St.Mary's hospital

Principal Investigators

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Kun-Ho Yoon, M.D., Ph.D.

Role: PRINCIPAL_INVESTIGATOR

The Catholic University of Korea

Locations

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Division of Endocrinology and Metabolism, St.Vincent's Hospital

Suwon, Kyonggi-do, South Korea

Site Status

Division of Endocrinology and Metabolism, Kangnam St.Mary's Hospital

Seoul, , South Korea

Site Status

Countries

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South Korea

References

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Meier JJ, Nauck MA. Is secretion of glucagon-like peptide-1 reduced in type 2 diabetes mellitus? Nat Clin Pract Endocrinol Metab. 2008 Nov;4(11):606-7. doi: 10.1038/ncpendmet0946. Epub 2008 Aug 26. No abstract available.

Reference Type BACKGROUND
PMID: 18725906 (View on PubMed)

Vollmer K, Holst JJ, Baller B, Ellrichmann M, Nauck MA, Schmidt WE, Meier JJ. Predictors of incretin concentrations in subjects with normal, impaired, and diabetic glucose tolerance. Diabetes. 2008 Mar;57(3):678-87. doi: 10.2337/db07-1124. Epub 2007 Dec 5.

Reference Type BACKGROUND
PMID: 18057091 (View on PubMed)

Nauck MA, Baller B, Meier JJ. Gastric inhibitory polypeptide and glucagon-like peptide-1 in the pathogenesis of type 2 diabetes. Diabetes. 2004 Dec;53 Suppl 3:S190-6. doi: 10.2337/diabetes.53.suppl_3.s190.

Reference Type BACKGROUND
PMID: 15561910 (View on PubMed)

Toft-Nielsen MB, Damholt MB, Madsbad S, Hilsted LM, Hughes TE, Michelsen BK, Holst JJ. Determinants of the impaired secretion of glucagon-like peptide-1 in type 2 diabetic patients. J Clin Endocrinol Metab. 2001 Aug;86(8):3717-23. doi: 10.1210/jcem.86.8.7750.

Reference Type BACKGROUND
PMID: 11502801 (View on PubMed)

Other Identifiers

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VCMC08OT066

Identifier Type: -

Identifier Source: secondary_id

KCMC08MI168

Identifier Type: -

Identifier Source: org_study_id

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