UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000022458
Receipt number R000025846
Scientific Title PET study on change of neurotransmitter release induced by exercise
Date of disclosure of the study information 2016/05/25
Last modified on 2019/04/02 20:30:10

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Basic information

Public title

PET study on change of neurotransmitter release induced by exercise

Acronym

Exercise PET on neurotransmitter release

Scientific Title

PET study on change of neurotransmitter release induced by exercise

Scientific Title:Acronym

Exercise PET on neurotransmitter release

Region

Japan


Condition

Condition

healthy volunteers

Classification by specialty

Adult

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

In the present study, we measure with positron emission tomography (PET) neuroreceptor density in the brain of healhty volunteers during the exercise and in the resting condition. We plan to evaluate the intrabrain release change in dopamin and histamine. IN addition, we plan to measure subjective such as fatigue, frank, quality of life (QOL) and cognitive functions, using questionnaires and computer test. All data will be examined to see correlations among factors.

Basic objectives2

Pharmacokinetics

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Others

Developmental phase

Not applicable


Assessment

Primary outcomes

*binding potential values that is reflecting receptor density for dopamin D2 receptor (11C-raclopride)
*binding potential values that is reflecting receptor density for histamine receptor (11C-doxepin)

Key secondary outcomes

*subjective feeling such as fatigue and frank measured with POMS as well as quality of life (QOL)
*autonomic nervous function
*blood chemistry (endocrine and immue)


Base

Study type

Interventional


Study design

Basic design

Single arm

Randomization

Non-randomized

Randomization unit


Blinding

Open -no one is blinded

Control

Self control

Stratification

NO

Dynamic allocation

NO

Institution consideration

Institution is not considered as adjustment factor.

Blocking

NO

Concealment

No need to know


Intervention

No. of arms

1

Purpose of intervention

Treatment

Type of intervention

Medicine Behavior,custom

Interventions/Control_1

Exercise load with an ergometer bicycle continuing up to 50 min (VO2max 55%). PET scanning starts during the exercise loading and pharmacokinetic information of 11C-raclopride (dopamin D2 receptor) measurement is done. The results are compared to those obtained under resting state.

Interventions/Control_2


Interventions/Control_3


Interventions/Control_4


Interventions/Control_5


Interventions/Control_6


Interventions/Control_7


Interventions/Control_8


Interventions/Control_9


Interventions/Control_10



Eligibility

Age-lower limit

20 years-old <=

Age-upper limit

30 years-old >=

Gender

Male

Key inclusion criteria

(1) right handed men with a habit of regular exercise of 1 or 2 days a week
(2) those who were judged as suitable for the current study by physical strength tests

Key exclusion criteria

(1) abnormality of brain structure shown by MRI
(2) any cardiac problems such as arrhythmia
(3) severe allergy
(4) regular administration of any therapeutic drugs

Target sample size

20


Research contact person

Name of lead principal investigator

1st name Manabu
Middle name
Last name Tashiro

Organization

Tohoku University Cyclotron and Radioisotope Center

Division name

Div. of Cyclotron Nuclear Medicine

Zip code

980-8578

Address

6-3 AzaAoba Aramaki Aoba-ku Sendai-shi Myagi-ken 980-8578 Japan

TEL

022-795-7797

Email

mtashiro@m.tohoku.ac.jp


Public contact

Name of contact person

1st name Kazuko
Middle name
Last name Takeda

Organization

Cyclotron and Radioisotope Center, Tohoku Univeristy

Division name

Div. of Cyclotron Nuclear Medicine

Zip code

980-8578

Address

6-3 AzaAoba Aramaki Aoba-ku Sendai-shi Myagi-ken 980-8578 Japan

TEL

022-795-4438

Homepage URL


Email

driving@cyric.tohoku.ac.jp


Sponsor or person

Institute

Tohoku University

Institute

Department

Personal name



Funding Source

Organization

Society for the promotion of science

Organization

Division

Category of Funding Organization

Japanese Governmental office

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor

University of Electro-Communications

Name of secondary funder(s)



IRB Contact (For public release)

Organization

Ethics comittee of Graduate School of Medicine, Tohoku University

Address

1-1 Seiryocho Aoba-ku Sendai-shi Miyagi-ken

Tel

0227178007

Email

med-kenkyo@grp.tohoku.ac.jp


Secondary IDs

Secondary IDs

YES

Study ID_1

2011-621

Org. issuing International ID_1

Clinical research ethics comittee of Tohoku University Hospital

Study ID_2


Org. issuing International ID_2


IND to MHLW



Institutions

Institutions

東北大学サイクロトロン・RIセンター


Other administrative information

Date of disclosure of the study information

2016 Year 05 Month 25 Day


Related information

URL releasing protocol


Publication of results

Unpublished


Result

URL related to results and publications


Number of participants that the trial has enrolled

17

Results

[11C]racloprinde PET measurements were done in Japanese young healthy volunteers in resting and exercise loading conditions. In comparison to resting condition, significantly better performance was observed in exercise loading condition. And increased dopamine release in the brain was also observed in PET images.

Results date posted

2019 Year 04 Month 02 Day

Results Delayed


Results Delay Reason


Date of the first journal publication of results


Baseline Characteristics


Participant flow


Adverse events


Outcome measures


Plan to share IPD


IPD sharing Plan description



Progress

Recruitment status

Completed

Date of protocol fixation

2016 Year 05 Month 25 Day

Date of IRB

2016 Year 05 Month 18 Day

Anticipated trial start date

2016 Year 05 Month 25 Day

Last follow-up date

2018 Year 12 Month 19 Day

Date of closure to data entry

2018 Year 12 Month 19 Day

Date trial data considered complete

2019 Year 02 Month 28 Day

Date analysis concluded

2019 Year 03 Month 20 Day


Other

Other related information



Management information

Registered date

2016 Year 05 Month 25 Day

Last modified on

2019 Year 04 Month 02 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000025846


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name