NCT00816608

Brief Summary

Hypothesis : The maximum body weight in lifetime is associated with the onset of development of type 2 diabetes.

Trial Health

87
On Track

Trial Health Score

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

Enrollment
3,000

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Aug 2006

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

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

August 1, 2006

Completed
2.4 years until next milestone

First Submitted

Initial submission to the registry

December 31, 2008

Completed
1 day until next milestone

First Posted

Study publicly available on registry

January 1, 2009

Completed
3.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 1, 2012

Completed
9 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2013

Completed
Last Updated

October 25, 2013

Status Verified

October 1, 2013

Enrollment Period

6.3 years

First QC Date

December 31, 2008

Last Update Submit

October 24, 2013

Conditions

DiabetesPrediabetes

Keywords

diabetesprediabetesimpaired fasting glucose (IFG)impaired glucose tolerance (IGT)body weight

Outcome Measures

Primary Outcomes (1)

  • The development of diabetes

    Five years

Secondary Outcomes (1)

  • DM complication

    5 years

Study Arms (1)

type 2 diabetes

Eligibility Criteria

Age20 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Korean with type 2 diabetes Korean with confirmed IFG or IGT Korean with NGT

You may qualify if:

  • Korean with type 2 diabetes
  • Korean with confirmed IFG or IGT
  • Korean with NGT

You may not qualify if:

  • Malignancy except thyroid cancer
  • Active tuberculosis

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Seoul National University Bundang Hospital

Seongnam, Bundang-gu, 463-707, South Korea

Location

MeSH Terms

Conditions

Diabetes MellitusPrediabetic StateGlucose IntoleranceBody Weight

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesHyperglycemiaSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Soo Lim

    Seoul National University Bundang Hospital

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
CASE ONLY
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor

Study Record Dates

First Submitted

December 31, 2008

First Posted

January 1, 2009

Study Start

August 1, 2006

Primary Completion

December 1, 2012

Study Completion

September 1, 2013

Last Updated

October 25, 2013

Record last verified: 2013-10

Locations

KR(1)