Opioid System Cerebral Activity in Endurance Sportswomen... | NCT02112695

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

NCT02112695

Sponsor

Centre Hospitalier Universitaire de Saint Etienne

Status

Completed

Last Update Posted

Oct 29, 2018Actual

Enrollment

35Actual

Phase

Not Applicable

Conditions

Sports Nutritional Sciences

Interventions

[11C]diprenorphine

Countries

France

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
2013-004733-32	EudraCT Number

Status Module

Record Verification Date

Oct 2017

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 15, 2014Actual

Primary Completion Date

Jul 6, 2017Actual

Completion Date

Jul 7, 2017Actual

First Submitted Date

Apr 10, 2014

First Submission Date that Met QC Criteria

Apr 11, 2014

First Posted Date

Apr 14, 2014Estimated

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

Oct 25, 2018

Last Update Posted Date

Oct 29, 2018Actual

Name	Class
Ministry of Health, France	OTHER_GOV

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

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

Not provided

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

35Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
sportswomen	Experimental	3 micrograms [11C]diprenorphine	Other: [11C]diprenorphine
control subjects	Experimental	3 micrgrams [11C]diprenorphine	Other: [11C]diprenorphine

Interventions

Name	Type	Description	Arm Group Labels	Other Names
[11C]diprenorphine	Other	3 micrograms [11C]diprenorphine - intravenous use - 1 time	control subjects sportswomen

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
[11C]diprenorphine binding potential	Value of [11C]diprenorphin binding potential in predifined brains regions. [11C]diprenorphin BP will be evaluated by brain positron emission tomography and MRI exam	2 weeks

Secondary Outcomes

Measure	Description	Time Frame
correlation [11C]diprenorphine BP	Correlation between [11C]Diprenorphine binding potential and plasma endogenous opioid levels	2 weeks
correlation [11C]diprenorphine BP	Correlation between [11C]Diprenorphine binding potential and psychometric score evaluating addictive behavior, reward and positive reinforcement

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

35 Years

Standard Ages

Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Bruno Estour, PU-PH	Centre Hospitalier Universitaire de Saint Etienne	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Service d'Endocrinologie - CHU Saint-Etienne		Saint-Etienne		42055	France

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

Condition Browse Module

MeSH Terms

ID	Term
D016739	Behavior, Addictive
D044342	Malnutrition

Ancestor Terms

ID	Term
D003192	Compulsive Behavior
D007175	Impulsive Behavior
D001519	Behavior
D009748	Nutrition Disorders

Browse Leaves

Not provided

Browse Branches

Not provided