Brown Adipose Tissue Activation: Effect of Exercise Train... | NCT03359824

Studies
Brown Adipose Tissue Activation: Effect of Exercise Training and Irisin

NCT03359824

Sponsor

Turku University Hospital

Status

Completed

Last Update Posted

Jan 22, 2019Actual

Enrollment

11Actual

Phase

Not Applicable

Conditions

Physical Activity

Interventions

Exercise

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

Jan 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

Sep 17, 2013Actual

Primary Completion Date

May 27, 2015Actual

Completion Date

May 27, 2015Actual

First Submitted Date

Nov 27, 2017

First Submission Date that Met QC Criteria

Nov 30, 2017

First Posted Date

Dec 2, 2017Actual

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

Jan 18, 2019

Last Update Posted Date

Jan 22, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Pirjo Nuutila, MD., Ph.D., Turku University HospitalPrincipal Investigator

Lead Sponsor

Turku University HospitalOTHER_GOV

Collaborators

Not provided

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

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

This study investigates the brown adipose tissue (BAT) activation and metabolism using positron emission tomography (PET) imaging before and after exercise training intervention at fasting state under normal room temperature and during cold stimulation.The investigators hypothesize that BAT glucose uptake is increased after exercise and BAT becomes metabolically more active.

Understanding the mechanisms of BAT activation and the role of exercise in humans is crucial to combat epidemic of obesity and diabetes.

Detailed Description

Exercise training has been suggested to activate and recruit human BAT through the activation of sympathetic nervous system and contracting skeletal muscles by the release of myokines such as lactate and irisin that signal WAT to induce expression of beige adipocytes. It has been also suggested that exercise training could enhance the metabolism of already existed functional BAT by increasing uncoupling protein-1 (UCP-1) gene transcription, mitochondrial biogenesis and hyperplasia. This is of clinical relevance because brown fat activation has been found to improve metabolic factors linked to obesity and diabetes.

In this study the investigators use a PET radiotracer 2-[18F] flouro-2-deoxy-D-glucose (FDG) to quantify the glucose uptake in BAT, whie adipose tissue and the muscle.The participants are scanned thrice at fast in this study once at room temperature, second at cold exposure and third after six weeks of exercise at cold exposure. This study will provide an insight about the role of exercise in activation of BAT metabolism.

Design Module

Study Type

Interventional

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 Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

11Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Exercise	Other	Arm: Exercise: Combination of moderate intensity continuous training, high intensity interval training and endurance training 5 times per week for a total of 6 weeks. Out of 5 sessions three were supervised by trainer and two sessions were performed by subjects on their own.The duration of the exercise was increased progressively. The first two weeks was 30 minutes that increased to 45 minutes in the third and fourth week. It was 60 minutes for the last two weeks.	Other: Exercise

Interventions

Name	Type	Description	Arm Group Labels	Other Names
Exercise	Other		Exercise

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Cold-induced glucose uptake in BAT after exercise	Glucose uptake of brown adipose tissue acquired with PET under cold exposure after exercise intervention. PET imaging is used to quantify glucose uptake in tissues	Within one study day

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Healthy sedentary volunteer
1. BMI 20-25 kg/m2
2. Age: 18-45 years
3. No chronic diseases

Exclusion Criteria:

BMI < 20 kg/m2 or BMI > 25 kg/m2
Mental disorder or poor compliance
Eating disorder or excessive use of alcohol or tobacco smoking
Any chronic disease
Past dose of radiation
Presence of any ferromagnetic objects that would make MR imaging contraindicated
Physically disability which rule out the physical fitness tests or participation in the exercise training intervention
Any other condition that in the opinion of the investigator could create a hazard to the subject safety, endanger the study procedures or interfere with the interpretation of study results

Accepts Healthy Volunteers

Yes

Sex

Male

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Pirjo Nuutila, MD, PhD	Turku UH	Principal Investigator

Locations

Not provided

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

ID	Term
D001519	Behavior

Intervention Browse Module

MeSH Terms

ID	Term
D015444	Exercise

Ancestor Terms

ID	Term
D009043	Motor Activity
D009068	Movement
D009142	Musculoskeletal Physiological Phenomena
D055687	Musculoskeletal and Neural Physiological Phenomena

Browse Leaves

Not provided

Browse Branches

Not provided