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

Sports Nutritional Sciences Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02112695
• Other study ID #: 1208051
• Secondary ID: 2013-004733-32
• Status: Completed
• Phase: N/A
• Start date: September 15, 2014
• Est. completion date: July 7, 2017

Study information

• Verified date: October 2017
• Source: Centre Hospitalier Universitaire de Saint Etienne
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 35
• Est. completion date: July 7, 2017
• Est. primary completion date: July 6, 2017
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 35 Years

Eligibility

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

Related Conditions & MeSH terms

• Behavior, Addictive
• Sports Nutritional Sciences

Intervention

Other:
• [11C]diprenorphine
3 micrograms [11C]diprenorphine - intravenous use - 1 time

Locations

Country	Name	City	State
France	Service d'Endocrinologie - CHU Saint-Etienne	Saint-Etienne

Sponsors (2)

Lead Sponsor	Collaborator
Centre Hospitalier Universitaire de Saint Etienne	Ministry of Health, France

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	[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	correlation [11C]diprenorphine BP	Correlation between [11C]Diprenorphine binding potential and plasma endogenous opioid levels	2 weeks
Secondary	correlation [11C]diprenorphine BP	Correlation between [11C]Diprenorphine binding potential and psychometric score evaluating addictive behavior, reward and positive reinforcement	2 weeks
Secondary	correlation [11C]diprenorphine BP	Correlation between [11C]Diprenorphine binding potential and appetite regulating hormones	2 weeks
Secondary	correlation [11C]diprenorphine BP	Correlation between [11C]Diprenorphine binding potential and LH response during GnRH test	2 weeks