Different Metabolic Characteristics in the Presence of Br... | NCT01430338

Studies
Different Metabolic Characteristics in the Presence of Brown Adipose Tissue in Humans

NCT01430338

Sponsor

Korea University

Status

Completed

Last Update Posted

Mar 17, 2015Estimated

Enrollment

90Actual

Phase

Not provided

Conditions

Metabolic Syndrome

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

Sep 2011

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

Dec 2010

Primary Completion Date

Dec 2011Actual

Completion Date

Not provided

First Submitted Date

Aug 24, 2011

First Submission Date that Met QC Criteria

Sep 7, 2011

First Posted Date

Sep 8, 2011Estimated

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

Mar 16, 2015

Last Update Posted Date

Mar 17, 2015Estimated

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

Functional brown adipose tissue (BAT) exists in adult humans and can be detected by PET and especially during acute cold exposure. It is conceivable that BAT activity might reduce the risk of developing obesity since fat stores are used for thermogenesis, and a directed enhancement of adipocyte metabolism might have value in weight reduction. So it is important to know the different metabolic characteristics in human adults who have detected BAT. Therefore, the purpose of the investigators study is to compare different metabolic characteristics in the presence of brown adipose tissue in humans.

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

Retention

Enrollment

90Actual

Label	Type	Description	Intervention Names
BAT		brown adipose tissue detected, undetected

Measure	Description	Time Frame
presence metabolic syndrome		5 months

Measure	Description	Time Frame
BMI		5 months
visceral fat area		5 months
adipokines

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Patients who underwent 18FDG-PET/CT scan year between 2008-2010

Exclusion Criteria:

History of cardiovascular disease (myocardial infarction, unstable angina, stroke, or cardiovascular revascularization)
Diabetes
Stage 2 hypertension
Severe renal or hepatic disease

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Patients who underwent 18FDG-PET/CT scan year between 2008-2010.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
korea University Guro Hospital		Seoul			South Korea

Condition Browse Module

MeSH Terms

ID	Term
D024821	Metabolic Syndrome

Ancestor Terms

ID	Term
D007333	Insulin Resistance
D006946	Hyperinsulinism
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided