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

Primary Purpose

Sports Nutritional Sciences

Status
Completed
Phase
Not Applicable
Locations
France
Study Type
Interventional
Intervention
[11C]diprenorphine
Sponsored by
Centre Hospitalier Universitaire de Saint Etienne
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional diagnostic trial for Sports Nutritional Sciences focused on measuring endurance sportswomen, addiction, undernutrition, [11C]diprenorphine Pet, pituitary region

Eligibility Criteria

18 Years - 35 Years (Adult)FemaleAccepts Healthy Volunteers

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

Sites / Locations

  • Service d'Endocrinologie - CHU Saint-Etienne

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

sportswomen

control subjects

Arm Description

3 micrograms [11C]diprenorphine

3 micrgrams [11C]diprenorphine

Outcomes

Primary Outcome Measures

[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

Secondary Outcome Measures

correlation [11C]diprenorphine BP
Correlation between [11C]Diprenorphine binding potential and plasma endogenous opioid levels
correlation [11C]diprenorphine BP
Correlation between [11C]Diprenorphine binding potential and psychometric score evaluating addictive behavior, reward and positive reinforcement
correlation [11C]diprenorphine BP
Correlation between [11C]Diprenorphine binding potential and appetite regulating hormones
correlation [11C]diprenorphine BP
Correlation between [11C]Diprenorphine binding potential and LH response during GnRH test

Full Information

First Posted
April 10, 2014
Last Updated
October 25, 2018
Sponsor
Centre Hospitalier Universitaire de Saint Etienne
Collaborators
Ministry of Health, France
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1. Study Identification

Unique Protocol Identification Number
NCT02112695
Brief Title
Opioid System Cerebral Activity in Endurance Sportswomen - Addiction or Denutrition ? [11C]Diprenorphine PET Study
Official Title
Opioid System Cerebral Activity in Endurance Sportswomen - Addiction or Denutrition ? [11C]Diprenorphine PET Study
Study Type
Interventional

2. Study Status

Record Verification Date
October 2017
Overall Recruitment Status
Completed
Study Start Date
September 15, 2014 (Actual)
Primary Completion Date
July 6, 2017 (Actual)
Study Completion Date
July 7, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Centre Hospitalier Universitaire de Saint Etienne
Collaborators
Ministry of Health, France

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Sports Nutritional Sciences
Keywords
endurance sportswomen, addiction, undernutrition, [11C]diprenorphine Pet, pituitary region

7. Study Design

Primary Purpose
Diagnostic
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
35 (Actual)

8. Arms, Groups, and Interventions

Arm Title
sportswomen
Arm Type
Experimental
Arm Description
3 micrograms [11C]diprenorphine
Arm Title
control subjects
Arm Type
Experimental
Arm Description
3 micrgrams [11C]diprenorphine
Intervention Type
Other
Intervention Name(s)
[11C]diprenorphine
Other Intervention Name(s)
radiopharmacentical precursor solution
Intervention Description
3 micrograms [11C]diprenorphine - intravenous use - 1 time
Primary Outcome Measure Information:
Title
[11C]diprenorphine binding potential
Description
Value of [11C]diprenorphin binding potential in predifined brains regions. [11C]diprenorphin BP will be evaluated by brain positron emission tomography and MRI exam
Time Frame
2 weeks
Secondary Outcome Measure Information:
Title
correlation [11C]diprenorphine BP
Description
Correlation between [11C]Diprenorphine binding potential and plasma endogenous opioid levels
Time Frame
2 weeks
Title
correlation [11C]diprenorphine BP
Description
Correlation between [11C]Diprenorphine binding potential and psychometric score evaluating addictive behavior, reward and positive reinforcement
Time Frame
2 weeks
Title
correlation [11C]diprenorphine BP
Description
Correlation between [11C]Diprenorphine binding potential and appetite regulating hormones
Time Frame
2 weeks
Title
correlation [11C]diprenorphine BP
Description
Correlation between [11C]Diprenorphine binding potential and LH response during GnRH test
Time Frame
2 weeks

10. Eligibility

Sex
Female
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
35 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Bruno Estour, PU-PH
Organizational Affiliation
CHU Saint-Etienne
Official's Role
Principal Investigator
Facility Information:
Facility Name
Service d'Endocrinologie - CHU Saint-Etienne
City
Saint-Etienne
ZIP/Postal Code
42055
Country
France

12. IPD Sharing Statement

Plan to Share IPD
No

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

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