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Correlation Between COMT Val158Met Polymorphism and Dopaminergic Transporter Density (DAT) in Obese Women

U

University of Sao Paulo

Status

Unknown

Conditions

Obesity

Treatments

Radiation: SPECT TRODAT-1

Study type

Observational

Funder types

Other

Identifiers

NCT04815122
Process HCRP 3.844.428

Details and patient eligibility

About

The present study aims to evaluate the correlation between the presence of COMT Val158Met polymorphism and the density of dopaminergic transporters (DAT) in young obese women.

Full description

The prevalence of obesity remains increasingly alarming in Brazil and worldwide. The most widely recommended therapy for obesity is lifestyle modification, however, implementing these changes that can lead to weight loss is difficult and maintaining a long-term weight loss is even more challenging. Consequently, an academic effort is required to understand the pathophysiology and treat obesity for the establishment of new approaches to reducing food intake.

Recent evidence in the field of obesity and brain-based integration indicates a potential for designing new therapeutic interventions. Noninvasive neuromodulation of brain activity has been shown to be a technique that can help reduce food cravings and food intake and, more recently, body weight, offering a new way to treat obesity. However, recent studies have shown that this biomedical intervention could have a paradoxical effect related to COMT Val158Met polymorphism, which impacts dopamine levels in the prefrontal cortex. The potential mechanisms underlying this effect are unclear and future studies are needed to promote this clarification.

This study aims to verify the influence of the COMT Val158Met polymorphism on the density of dopaminergic transporters in the presynaptic membrane of dopaminergic neurons, exploring the 3 dopaminergic pathways: via nigroestrital, mesolimbic and mesocortical. This investigation will be carried out through the cerebral SPECT using the radiopharmaceutical 99mTecnécio-TRODAT-1 in young obese women with and without COMT Val158Met polymorphism. In baseline conditions, the investigators will compare the SPECT 99mTc-TRODAT-1 of obese women with and without the COMT Val158Met polymorphism with a database of non-obese volunteers.

Our hypothesis is that the study will facilitate understanding of the variability of the individual response of carriers and non-carriers of the Met allele of the COMT Val158Met polymorphism, affecting dopamine levels in the brain and to design, in the future, for the treatment of obesity based on the individuals' genotypic differences.

Enrollment

38 estimated patients

Sex

Female

Ages

20 to 40 years old

Volunteers

No Healthy Volunteers

Inclusion criteria

  • Women with obesity (BMI 30-35kg/m2), with and without COMT Val158Met polymorphism.

Exclusion criteria

  • pregnancy
  • any active psychiatric or neurological condition at the time of joining the study
  • any other significant medical condition

Trial design

38 participants in 2 patient groups

Carriers of the Met allele of the COMT Val158Met polymorphism
Description:
Women with obesity carriers of the Met allele of the COMT Val158Met polymorphism
Treatment:
Radiation: SPECT TRODAT-1
Non-carriers of the Met allele of the COMT Val158Met polymorphism
Description:
Women with obesity non-carriers of the Met allele of the COMT Val158Met polymorphism
Treatment:
Radiation: SPECT TRODAT-1

Trial contacts and locations

1

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Central trial contact

Priscila G Fassini, PhD

Data sourced from clinicaltrials.gov

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