The Effect of Maximum Body Weight in Lifetime on the Deve... | NCT00816608

Studies
The Effect of Maximum Body Weight in Lifetime on the Development of Type 2 Diabetes

NCT00816608

Sponsor

Seoul National University Bundang Hospital

Status

Completed

Last Update Posted

Oct 25, 2013Estimated

Enrollment

3,000Actual

Phase

Not provided

Conditions

Diabetes
Prediabetes

Interventions

Not provided

Countries

South Korea

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

Oct 2013

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

Aug 2006

Primary Completion Date

Dec 2012Actual

Completion Date

Sep 2013Actual

First Submitted Date

Dec 31, 2008

First Submission Date that Met QC Criteria

Dec 31, 2008

First Posted Date

Jan 1, 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

Oct 24, 2013

Last Update Posted Date

Oct 25, 2013Estimated

Sponsor/Collaborators Module

Responsible Party, by Official Title

Soo Lim, Professor, Seoul National University Bundang HospitalPrincipal Investigator

Lead Sponsor

Seoul National University Bundang HospitalOTHER

Collaborators

Not provided

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

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

Detailed Description

Obesity is well recognized risk factor for type 2 diabetes. Recent studies reported that weight change, especially severe weight gain was associated with an increased risk of type 2 diabetes. The aim of this study is to investigate whether the maximum body weight of lifetime is associated with the early onset of type 2 diabetes or an increased risk of type 2 diabetes in Korean.

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

3,000Actual

Label	Type	Description	Intervention Names
type 2 diabetes

Measure	Description	Time Frame
The development of diabetes		Five years

Measure	Description	Time Frame
DM complication		5 years

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

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

Exclusion Criteria:

Malignancy except thyroid cancer
Active tuberculosis

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

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

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Soo Lim	Seoul National University Bundang Hospital	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Seoul National University Bundang Hospital		Seongnam	Bundang-gu	463-707	South Korea

Condition Browse Module

MeSH Terms

ID	Term
D003920	Diabetes Mellitus
D011236	Prediabetic State
D018149	Glucose Intolerance
D001835	Body Weight

Ancestor Terms

ID	Term
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided