Longitudinal Follow-up of Brown Adipose Tissue Function a... | NCT01985503

Studies
Longitudinal Follow-up of Brown Adipose Tissue Function and Structure

NCT01985503

Sponsor

Turku University Hospital

Status

Completed

Last Update Posted

May 6, 2019Actual

Enrollment

95Estimated

Phase

Not provided

Conditions

Obesity

Interventions

Not provided

Countries

Finland

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

ID	Type	Description	Link
BATFOLLOWUP	Other Identifier	PET Centre, Turku University

Status Module

Record Verification Date

May 2019

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

Jan 2015Actual

Primary Completion Date

Dec 31, 2017Actual

Completion Date

Dec 31, 2017Actual

First Submitted Date

Nov 4, 2013

First Submission Date that Met QC Criteria

Nov 8, 2013

First Posted Date

Nov 15, 2013Estimated

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

May 2, 2019

Last Update Posted Date

May 6, 2019Actual

Oversight Module

Has Data Monitoring Committee (DMC)

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

In Turku PET Centre, there have been 3 positron emission tomography studies on brown adipose tissue (BAT) activity in healthy adults. BATPET was performed between 2008 and 2009. FATBAT started in 2011 and Dixon-BAT in 2012 and they are both currently ongoing. In the current study, participants of BATPET, FATBAT and Dixon-BAT studies are recruited for a follow-up study to examine associations between obesity, cardiovascular risk factors, serum metabolic profile and BAT structure at baseline and during follow-up several years later. 43 BATPET participants will be called for follow-up in 2013 with a follow-up period of 5 years and 52 FATBAT and Dixon-BAT participants in years 2014 and 2015 with a follow-up period of 3 years. The aim of this study is to examine longitudinal associations between BAT function and structure, liver adiposity and cardiovascular risk factors at baseline and during follow-up.

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

Yes

Target Follow-Up Duration

5 Years

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

Retention

Enrollment

95Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Phase 1 group		Subjects were studied in 2009 and their follow-up is in 2014.
Phase 2 group		Subjects were studied in 2011 and their follow-up is in 2016.

Interventions

Not provided

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Correlation between baseline brown adipose tissue activity according to PET imaging and serum lipoprotein concentrations at follow-up 5 years later	Brown adipose tissue activity is determined with FDG-PET imaging at baseline in 43 subjects and 5 years later the subjects participate a follow-up visit where lipoprotein levels are measured in mmol/l from serum samples. Correlation between brown adipose tissue activity and serum lipoproteins are examined with Pearson's correlation.	5 years

Secondary Outcomes

Measure	Description	Time Frame
Association between brown adipose tissue structure at baseline and at follow-up		5 years

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

All study subjects have been screened prior to acceptance in BATPET, FATBAT and Dixon-BAT studies and no screening for inclusion is required in the current study.

Exclusion Criteria:

1) Smoking 2) Blood pressure > 160/100 mmHg 3) Pregnancy or lactation 4) Medication (expected effect on study variables)

Accepts Healthy Volunteers

Yes

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

22 Years

Maximum Age

55 Years

Standard Ages

Adult

Study Population

Study subjects are healthy 22-55-year-old Caucasians. Population contains both lean and obese subjects.

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Juho RH Raiko, MD, PhD	PET Centre, Turku Univesity	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
PET Centre, Turku University		Turku		20100	Finland

Condition Browse Module

MeSH Terms

ID	Term
D009765	Obesity
D002318	Cardiovascular Diseases

Ancestor Terms

ID	Term
D050177	Overweight
D044343	Overnutrition
D009748	Nutrition Disorders
D009750	Nutritional and Metabolic Diseases

Browse Leaves

Not provided

Browse Branches

Not provided