Short-term Effect of Intensive Insulin Therapy on Incretin Secretion

Study Description

Go to 

Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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 Design

Go to 

Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Groups and Cohorts

Go to 

Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Group/Cohort
wDM; Early diabetes
pDM; Poorly controlled diabetic patients

Outcome Measures

Go to 

Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Eligibility Criteria

Go to 

Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Contacts and Locations

Go to 

Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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

Go to 

Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Publications:

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.

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.

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.

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.

Responsible Party:	Kun-Ho Yoon, Kangnam St.Mary's hospital
ClinicalTrials.gov Identifier:	NCT00776243 History of Changes
Other Study ID Numbers:	KCMC08MI168; VCMC08OT066
First Posted:	October 21, 2008
Last Update Posted:	May 12, 2010
Last Verified:	October 2009

Keywords provided by The Catholic University of Korea:

incretin; GLP-1; GIP; intensive insulin therapy

Additional relevant MeSH terms:

Insulin; Incretins; Hypoglycemic Agents	Physiological Effects of Drugs; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists