Short-term Effect of Intensive Insulin Therapy on Incretin Secretion - Full Text View

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:

Drug Information available for: Insulin Insulin human

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 ]

Secondary Outcome Measures:

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

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 (Adult, Senior)
Sexes Eligible for Study:	All
Accepts Healthy Volunteers:	Yes
Sampling Method:	Non-Probability Sample

Study Population

Subjects with normal glucose tolerance
Early diabetic patients with disease duration of less than 5years
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

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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:

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
Study First Received:	October 20, 2008
Last Updated:	May 10, 2010

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

ClinicalTrials.gov processed this record on July 21, 2017