Progression to Impaired Glucose Tolerance and Type 2 Diab... | NCT01034826

Studies
Progression to Impaired Glucose Tolerance and Type 2 Diabetes in the Korean People-based KNDP Study

NCT01034826

Sponsor

Korea University Guro Hospital

Status

Completed

Last Update Posted

Jun 9, 2010Estimated

Enrollment

500Estimated

Phase

Not provided

Conditions

Impaired Glucose Tolerance
Diabetes

Interventions

Not provided

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Dec 2009

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2007

Primary Completion Date

Dec 2009Actual

Completion Date

May 2010Actual

First Submitted Date

Dec 17, 2009

First Submission Date that Met QC Criteria

Dec 17, 2009

First Posted Date

Dec 18, 2009Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 8, 2010

Last Update Posted Date

Jun 9, 2010Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Yes

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

Impaired glucose tolerance is a metabolic state between normal glucose homeostasis and diabetes. Previously, prospective studies have shown higher progression rates from IGT to diabetes in other country. But There is no prospective-multicenter based reports in Korea. Therefore, the purpose of this study is to estimate the progression rates to impair glucose regulation and diabetes in the Korean population-based Korea national Diabetes program.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

500Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
life style modification		everyone in this study was advised about their life style, diet, exercise habits.

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
fasting serum glucose, fasting plasma insulin,post prandial serum glucose, post prandial plasma insulin, hbA1c		0.1.3.5 year

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

fastic serum glucose >100 and/or pp2 serum glucose <200

Exclusion Criteria:

known diabetes
organ failure(For example, liver, kidney)
known malignancy

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

80 Years

Standard Ages

AdultOlder Adult

Study Population

patients who vist the endocrinology department due to impaired fasting glucose or impaired glucose tolerance, or both.

Sampling Method

Probability Sample

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
22837306	Derived	Choi KM, Hwang SY, Hong HC, Yang SJ, Choi HY, Yoo HJ, Lee KW, Nam MS, Park YS, Woo JT, Kim YS, Choi DS, Youn BS, Baik SH. C1q/TNF-related protein-3 (CTRP-3) and pigment epithelium-derived factor (PEDF) concentrations in patients with type 2 diabetes and metabolic syndrome. Diabetes. 2012 Nov;61(11):2932-6. doi: 10.2337/db12-0217. Epub 2012 Jul 26.

ID	Term
D018149	Glucose Intolerance
D003920	Diabetes Mellitus

ID	Term
D006943	Hyperglycemia
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases