Short-term Effect of Intensive Insulin Therapy on Incretin Secretion

Type 2 Diabetes Clinical Trial

Official title:

Short-term Effect of Intensive Insulin Therapy on Incretin Secretion

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00776243
• Other study ID #: KCMC08MI168
• Secondary ID: VCMC08OT066
• Status: Completed
• Phase: N/A
• First received: October 20, 2008
• Last updated: May 10, 2010
• Start date: October 2008
• Est. completion date: December 2009

Study information

• Verified date: October 2009
• Source: The Catholic University of Korea
• Contact: n/a
• Is FDA regulated: No
• Health authority: South Korea: Institutional Review Board
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: December 2009
• Est. primary completion date: December 2009
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 20 Years to 70 Years

Eligibility

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 Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Type 2 Diabetes

Locations

Country	Name	City	State
Korea, Republic of	Division of Endocrinology and Metabolism, Kangnam St.Mary's Hospital	Seoul
Korea, Republic of	Division of Endocrinology and Metabolism, St.Vincent's Hospital	Suwon	Kyonggi-do

Sponsors (1)

Lead Sponsor	Collaborator
The Catholic University of Korea

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (4)

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. — View Citation

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. Review. — View Citation

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. — View Citation

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. Epub 2007 Dec 5. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference of incretin secretion before and after intensive insulin therapy		2 months	No
Secondary	Difference in incretin secretion according to the duration of diabetes		basal	No
Secondary	Factors affecting incretin secretion		basal	No