Opioid System Cerebral Activity in Endurance Sportswomen - Addiction or Denutrition ? [11C]Diprenorphine PET Study

NCT ID: NCT02112695

Last Updated: 2018-10-29

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

35 participants

Study Classification

INTERVENTIONAL

Study Start Date

2014-09-15

Study Completion Date

2017-07-07

Brief Summary

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Abnormal opioid system have been identified in addictive behavior and activity of the opioid system has also shown a strong link with the nutritional balance. A significant increase in endorphin levels was noticed after exercise, proportional to the duration and intensity of this activity. One brain imaging study showed an increase in opioid activity in athletes after endurance training. However , a decrease in opioid tone related to receptor desensitization in the brain has been raised in the sport and it is possible to feel like , the subject must perform physical exercise more frequently . Consequently, in order to deepen the hypothesis of addiction in high-level sport , the brain opioid activity should be assessed pre- training compared to a group of sedentary control subjects .

Preliminary results of a previous study the investigators are conducting on anorexia nervosa (AN ) show abnormalities that appear to be involved in self addiction anorexia nervosa and the regulation of gonadal function. However, the relation of cause and effect between these anomalies and undernutrition remains to be determined . Given the addictive component in the endurance sport and the variability of the nutritional status of its practitioners , evaluation of brain activity in these subjects could provide additional answers.

Detailed Description

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Conditions

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Sports Nutritional Sciences

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

DIAGNOSTIC

Blinding Strategy

NONE

Study Groups

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sportswomen

3 micrograms \[11C\]diprenorphine

Group Type EXPERIMENTAL

[11C]diprenorphine

Intervention Type OTHER

3 micrograms \[11C\]diprenorphine - intravenous use - 1 time

control subjects

3 micrgrams \[11C\]diprenorphine

Group Type EXPERIMENTAL

[11C]diprenorphine

Intervention Type OTHER

3 micrograms \[11C\]diprenorphine - intravenous use - 1 time

Interventions

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[11C]diprenorphine

3 micrograms \[11C\]diprenorphine - intravenous use - 1 time

Intervention Type OTHER

Other Intervention Names

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radiopharmacentical precursor solution

Eligibility Criteria

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Inclusion Criteria

For High-level sportswomen :

* 18-35-year-old
* High-level sportswomen
* BMI\>19kg/m2
* Absence of eating disorders
* In pre-competition period
* Signature of written consent

For controls :

* 18-35-year-old
* Sedentary normal weight women
* BMI\>19kg/m2
* Normal nutritional markers
* Absence of eating disorders or other psychiatric or organic diseases

Exclusion Criteria

* Oral contraception
* Heart failure
* Neuroleptics, antiparkinson drugs, alpha-methyl-dopa, beta blockers, inhibitors of monoamine oxidase-A or MOA-B, tricyclic antidepressants, selective serotonin reuptake inhibitor, thyme-regulators (lithium), anticonvulsant drugs, codeine, morphine, drugs containing tramadol, dopaminergic drugs
Minimum Eligible Age

18 Years

Maximum Eligible Age

35 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Ministry of Health, France

OTHER_GOV

Sponsor Role collaborator

Centre Hospitalier Universitaire de Saint Etienne

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Bruno Estour, PU-PH

Role: PRINCIPAL_INVESTIGATOR

CHU SAINT-ETIENNE

Locations

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Service d'Endocrinologie - CHU Saint-Etienne

Saint-Etienne, , France

Site Status

Countries

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France

Other Identifiers

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2013-004733-32

Identifier Type: EUDRACT_NUMBER

Identifier Source: secondary_id

1208051

Identifier Type: -

Identifier Source: org_study_id

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