Short-term Effect of Intensive Insulin Therapy on Incretin Secretion

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT00776243

Enrollment

Registered

2008-10-21

Start date

2008-10-31

Completion date

2009-12-31

Last updated

2010-05-12

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Type 2 Diabetes

Keywords

incretin, GLP-1, GIP, intensive insulin therapy

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.

Interventions

None listed

Study design

Observational model

CASE_CONTROL

Time perspective

PROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

20 Years to 70 Years

Healthy volunteers

Yes

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

Design outcomes

Primary

Measure	Time frame
Difference of incretin secretion before and after intensive insulin therapy	2 months

Secondary

Measure	Time frame
Difference in incretin secretion according to the duration of diabetes	basal
Factors affecting incretin secretion	basal

Countries

South Korea

Outcome results