NCT00776243

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
30

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2008

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2008

Completed
19 days until next milestone

First Submitted

Initial submission to the registry

October 20, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

October 21, 2008

Completed
1.1 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2009

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2009

Completed
Last Updated

May 12, 2010

Status Verified

October 1, 2009

Enrollment Period

1.2 years

First QC Date

October 20, 2008

Last Update Submit

May 10, 2010

Conditions

Type 2 Diabetes

Keywords

incretinGLP-1GIPintensive insulin therapy

Outcome Measures

Primary Outcomes (1)

  • Difference of incretin secretion before and after intensive insulin therapy

    2 months

Secondary Outcomes (2)

  • Difference in incretin secretion according to the duration of diabetes

    basal

  • Factors affecting incretin secretion

    basal

Study Arms (2)

wDM

Early diabetes

pDM

Poorly controlled diabetic patients

Eligibility Criteria

Age20 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Division of Endocrinology and Metabolism, St.Vincent's Hospital

Suwon, Kyonggi-do, 442-723, South Korea

Location

Division of Endocrinology and Metabolism, Kangnam St.Mary's Hospital

Seoul, 137-701, South Korea

Location

Related 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. No abstract available.

    PMID: 18725906BACKGROUND

  • 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. doi: 10.2337/db07-1124. Epub 2007 Dec 5.

    PMID: 18057091BACKGROUND

  • 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. doi: 10.2337/diabetes.53.suppl_3.s190.

    PMID: 15561910BACKGROUND

  • 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. doi: 10.1210/jcem.86.8.7750.

    PMID: 11502801BACKGROUND

Biospecimen

Retention: SAMPLES WITHOUT DNA

plasma serum

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Kun-Ho Yoon, M.D., Ph.D.

    The Catholic University of Korea

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER

Study Record Dates

First Submitted

October 20, 2008

First Posted

October 21, 2008

Study Start

October 1, 2008

Primary Completion

December 1, 2009

Study Completion

December 1, 2009

Last Updated

May 12, 2010

Record last verified: 2009-10

Locations

KR(2)