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

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.

Study Overview

• Status: Completed
• Conditions: Sports Nutritional Sciences
• Intervention / Treatment: Other: [11C]diprenorphine

• Study Type: Interventional
• Enrollment (Actual): 35
• Phase: Not Applicable

Contacts and Locations

Study Locations

• France
  • Saint-Etienne, France, 42055
    • Service d'Endocrinologie - CHU Saint-Etienne

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 35 years (Adult)
• Accepts Healthy Volunteers: Yes
• Genders Eligible for Study: Female

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Diagnostic
• Allocation: Non-Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: sportswomen; 3 micrograms [11C]diprenorphine	Other: [11C]diprenorphine; 3 micrograms [11C]diprenorphine - intravenous use - 1 time; Other Names: radiopharmacentical precursor solution
Experimental: control subjects; 3 micrgrams [11C]diprenorphine	Other: [11C]diprenorphine; 3 micrograms [11C]diprenorphine - intravenous use - 1 time; Other Names: radiopharmacentical precursor solution

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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 Outcome Measures

Outcome Measure	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	2 weeks
correlation [11C]diprenorphine BP	Correlation between [11C]Diprenorphine binding potential and appetite regulating hormones	2 weeks
correlation [11C]diprenorphine BP	Correlation between [11C]Diprenorphine binding potential and LH response during GnRH test	2 weeks

Collaborators and Investigators

• Sponsor: Centre Hospitalier Universitaire de Saint Etienne
• Collaborators: Ministry of Health, France
• Investigators: Principal Investigator: Bruno Estour, PU-PH, CHU Saint-Etienne

Study record dates

Study Major Dates

• Study Start (Actual): September 15, 2014
• Primary Completion (Actual): July 6, 2017
• Study Completion (Actual): July 7, 2017

Study Registration Dates

• First Submitted: April 10, 2014
• First Submitted That Met QC Criteria: April 11, 2014
• First Posted (Estimate): April 14, 2014

Study Record Updates

• Last Update Posted (Actual): October 29, 2018
• Last Update Submitted That Met QC Criteria: October 25, 2018
• Last Verified: October 1, 2017

More Information

Terms related to this study

• Keywords: addiction; undernutrition; endurance sportswomen; [11C]diprenorphine Pet; pituitary region
• Additional Relevant MeSH Terms: Compulsive Behavior; Impulsive Behavior; Behavior, Addictive; Physiological Effects of Drugs; Peripheral Nervous System Agents; Sensory System Agents; Narcotic Antagonists; Diprenorphine
• Other Study ID Numbers: 1208051; 2013-004733-32 (EudraCT Number)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No