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

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.

Study Overview

• Status: Completed
• Conditions: Nuclear Medicine
• Intervention / Treatment: Diagnostic test: PET for the analysis of mu opioid receptor expression.

• Study Type: Observational
• Enrollment (Actual): 16

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult
• Accepts Healthy Volunteers: N/A

• 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.

Description

Inclusion Criteria:

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

Exclusion Criteria:

• drug allergy;
• clinical evidence of neuropsychiatric pathologies.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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

Collaborators and Investigators

• Sponsor: IRCCS San Raffaele

Study record dates

Study Major Dates

• Study Start (Actual): October 22, 2004
• Primary Completion (Actual): December 1, 2007
• Study Completion (Actual): December 1, 2007

Study Registration Dates

• First Submitted: December 12, 2023
• First Submitted That Met QC Criteria: December 21, 2023
• First Posted (Actual): December 22, 2023

Study Record Updates

• Last Update Posted (Actual): March 6, 2024
• Last Update Submitted That Met QC Criteria: March 5, 2024
• Last Verified: March 1, 2024

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Central Nervous System Depressants; Peripheral Nervous System Agents; Analgesics; Sensory System Agents; Narcotics; Analgesics, Opioid
• Other Study ID Numbers: CARF-2

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