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Completed

NCT Number: NCT00776243

Short-term Effect of Intensive Insulin Therapy on Incretin Secretion

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.

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Key information

Conditions

Type 2 Diabetes Diabetes Mellitus Diabetes Mellitus, Type 2 Endocrine System Diseases Glucose Metabolism Disorders Metabolic Diseases Nutritional and Metabolic Diseases

Age range

20 year–70 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Division of Endocrinology and Metabolism, St.Vincent's Hospital, Suwon, Kyonggi-do, South Korea

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Primary outcomes

  1. Difference of incretin secretion before and after intensive insulin therapy

    Time frame: 2 months

Secondary outcomes

  1. Difference in incretin secretion according to the duration of diabetes

    Time frame: basal

  2. Factors affecting incretin secretion

    Time frame: basal

Sponsors and collaborators

Lead sponsor

The Catholic University of Korea

Other

Registry information

Important dates

Study start
2008
Primary completion
2009
Study completion
2009
First posted
Oct 21, 2008
Registry last updated
May 12, 2010

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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