Study of the in Vivo Expression of MU Opioid Receptors Using PET and the Selective Tracer [C-11] Carfentanil in Normal Weight and Obese Subjects

NCT06180200 | Completed

• 1 other identifier: CARF-2
• Study Type: observational
• Target: 16
• Locations: 0 countries
• Sites: N/A

Brief Summary

Positron emission tomography (PET) is a nuclear medicine technique that allows the measurement, in vivo in humans, with a non-invasive method, of the regional distribution of substances marked with positron emission isotopes such as C-11, in different districts bodily. Using this method it is therefore possible to directly measure at the level of the brain the distribution of receptors, enzymes, reuptake sites, as well as their interaction with various classes of drugs and the related modifications that may be present during the pathology. The evaluation of the endogenous opiate receptor system will be implemented by comparing the in vivo binding maps of 11C carfentanil in the two groups of subjects under examination (normal weight, NOR and obese, OB, based on body mass index, BMI); in fact, experimental data deriving from previous studies support the hypothesis that the basis of obesity and incorrect eating behaviors is a dysregulation of the endogenous ligand-mu opioid receptor interaction. The comparison of the data deriving from the analysis of the PET exams performed on the two groups of subjects will therefore allow us to evaluate the alterations of the opioid system possibly present in obese subjects.

Conditions

Nuclear Medicine

Outcome Measures

Primary Outcomes (1)

• PET with 11C CARFENTANIL for the analysis of the expression of mu opioid receptors.

  Study of the expression of mu opioid receptors in normal weight and obese subjects

  3 years

Interventions

PET for the analysis of mu opioid receptor expression. DIAGNOSTIC_TEST

PET for the analysis of the expression of mu opioid receptors and to directly measure the distribution of the receptors and enzyme reuptake sites at the brain level.

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: male
• Age Groups: Adult (18-64)
• Sampling Method: Probability Sample

Study Population

For the study, 10 normal male subjects and 10 obese subjects not affected by mental or physical pathological alterations will be recruited.

You may qualify if:

• aged between 18 and 40 years;
• structured sports activity \< 2 hours per week

You may not qualify if:

• drug allergy;
• clinical evidence of neuropsychiatric pathologies.

Sponsors & Collaborators

• IRCCS San Raffaele: lead

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor in Diagnostic Imaging and Radiotherapy Faculty of Medicine and Surgery, Vita-Salute San Raffaele University Director, Department of Nuclear Medicine, IRCCS Ospedale San Raffaele

Study Record Dates

• First Submitted: December 12, 2023
• First Posted: December 22, 2023
• Study Start: October 22, 2004
• Primary Completion: December 1, 2007
• Study Completion: December 1, 2007
• Last Updated: March 6, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share