NCT04815122

Brief Summary

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
38

participants targeted

Target at P25-P50 for all trials

Timeline
Completed

Started Apr 2021

Shorter than P25 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

March 5, 2021

Completed
19 days until next milestone

First Posted

Study publicly available on registry

March 24, 2021

Completed
8 days until next milestone

Study Start

First participant enrolled

April 1, 2021

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2021

Completed
Last Updated

March 24, 2021

Status Verified

March 1, 2021

Enrollment Period

7 months

First QC Date

March 5, 2021

Last Update Submit

March 23, 2021

Conditions

Obesity

Keywords

ObesityGenetic polymorphismDopamine

Outcome Measures

Primary Outcomes (1)

  • Density of Dopaminergic transporters (DAT)

    The primary outcome is to compare the density of dopaminergic transporters (DAT) in the 3 dopaminergic pathways: via nigroestrital, mesolimbic and mesocortical in obese women with and without COMT Val158Met polymorphism.

    During the procedure

Study Arms (2)

Carriers of the Met allele of the COMT Val158Met polymorphism

Women with obesity carriers of the Met allele of the COMT Val158Met polymorphism

Radiation: SPECT TRODAT-1

Non-carriers of the Met allele of the COMT Val158Met polymorphism

Women with obesity non-carriers of the Met allele of the COMT Val158Met polymorphism

Radiation: SPECT TRODAT-1

Interventions

SPECT TRODAT-1RADIATION

The Single-photon Emission Tomography (SPECT) TRODAT-1 will be performed after the voluntary rest in a dark and silent room for 30 minutes, to eliminate possible influences from external stimuli; the radiopharmaceutical \[99mTC\] -TRODAT-1 will be injected through the venous access previously established, 4 hours after the injection of the radiopharmaceutical, the acquisition of cerebral SPECT will be performed in the two groups of obese women, with and without COMT Val158Met polymorphism. The images will be acquired on Philips BrightView XCT equipment, equipped with a double detector.

Carriers of the Met allele of the COMT Val158Met polymorphismNon-carriers of the Met allele of the COMT Val158Met polymorphism

Eligibility Criteria

Age20 Years - 40 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

Young women with obesity (BMI 30-35kg/m2), with and without COMT Val158Met polymorphism who participated in a previous study registered at clinicaltrials.gov (NCT02953353).

You may qualify if:

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

You may not qualify if:

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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Clinical Hospital of Ribeirão Preto Medical School

Ribeirão Preto, São Paulo, 14048-900, Brazil

RECRUITING

Related Publications (11)

  • Avsar O, Kuskucu A, Sancak S, Genc E. Are dopaminergic genotypes risk factors for eating behavior and obesity in adults? Neurosci Lett. 2017 Jul 27;654:28-32. doi: 10.1016/j.neulet.2017.06.023. Epub 2017 Jun 16.

    PMID: 28629779BACKGROUND

  • Barnett JH, Scoriels L, Munafo MR. Meta-analysis of the cognitive effects of the catechol-O-methyltransferase gene Val158/108Met polymorphism. Biol Psychiatry. 2008 Jul 15;64(2):137-44. doi: 10.1016/j.biopsych.2008.01.005. Epub 2008 Mar 14.

    PMID: 18339359BACKGROUND

  • Chen PS, Yang YK, Yeh TL, Lee IH, Yao WJ, Chiu NT, Lu RB. Correlation between body mass index and striatal dopamine transporter availability in healthy volunteers--a SPECT study. Neuroimage. 2008 Mar 1;40(1):275-9. doi: 10.1016/j.neuroimage.2007.11.007. Epub 2007 Nov 21.

    PMID: 18096411BACKGROUND

  • Fassini PG, Das SK, Suen VMM, Magerowski G, Marchini JS, da Silva Junior WA, Changyu S, Alonso-Alonso M. Appetite effects of prefrontal stimulation depend on COMT Val158Met polymorphism: A randomized clinical trial. Appetite. 2019 Sep 1;140:142-150. doi: 10.1016/j.appet.2019.05.015. Epub 2019 May 13.

    PMID: 31095973BACKGROUND

  • Fassini PG, Das SK, Magerowski G, Marchini JS, da Silva Junior WA, da Silva IR, de Souza Ribeiro Salgueiro R, Machado CD, Suen VMM, Alonso-Alonso M. Noninvasive neuromodulation of the prefrontal cortex in young women with obesity: a randomized clinical trial. Int J Obes (Lond). 2020 Jun;44(6):1279-1290. doi: 10.1038/s41366-020-0545-3. Epub 2020 Feb 19.

    PMID: 32076105BACKGROUND

  • Fonteneau C, Redoute J, Haesebaert F, Le Bars D, Costes N, Suaud-Chagny MF, Brunelin J. Frontal Transcranial Direct Current Stimulation Induces Dopamine Release in the Ventral Striatum in Human. Cereb Cortex. 2018 Jul 1;28(7):2636-2646. doi: 10.1093/cercor/bhy093.

    PMID: 29688276BACKGROUND

  • Horstmann A, Fenske WK, Hankir MK. Argument for a non-linear relationship between severity of human obesity and dopaminergic tone. Obes Rev. 2015 Oct;16(10):821-30. doi: 10.1111/obr.12303. Epub 2015 Jun 22.

    PMID: 26098597BACKGROUND

  • Van Laere K, De Ceuninck L, Dom R, Van den Eynden J, Vanbilloen H, Cleynhens J, Dupont P, Bormans G, Verbruggen A, Mortelmans L. Dopamine transporter SPECT using fast kinetic ligands: 123I-FP-beta-CIT versus 99mTc-TRODAT-1. Eur J Nucl Med Mol Imaging. 2004 Aug;31(8):1119-27. doi: 10.1007/s00259-004-1480-6. Epub 2004 Apr 3.

    PMID: 15064872BACKGROUND

  • Slifstein M, Kolachana B, Simpson EH, Tabares P, Cheng B, Duvall M, Frankle WG, Weinberger DR, Laruelle M, Abi-Dargham A. COMT genotype predicts cortical-limbic D1 receptor availability measured with [11C]NNC112 and PET. Mol Psychiatry. 2008 Aug;13(8):821-7. doi: 10.1038/mp.2008.19. Epub 2008 Mar 4.

    PMID: 18317466BACKGROUND

  • Volkow ND, Wang GJ, Telang F, Fowler JS, Thanos PK, Logan J, Alexoff D, Ding YS, Wong C, Ma Y, Pradhan K. Low dopamine striatal D2 receptors are associated with prefrontal metabolism in obese subjects: possible contributing factors. Neuroimage. 2008 Oct 1;42(4):1537-43. doi: 10.1016/j.neuroimage.2008.06.002. Epub 2008 Jun 13.

    PMID: 18598772BACKGROUND

  • Wang GJ, Volkow ND, Logan J, Pappas NR, Wong CT, Zhu W, Netusil N, Fowler JS. Brain dopamine and obesity. Lancet. 2001 Feb 3;357(9253):354-7. doi: 10.1016/s0140-6736(00)03643-6.

    PMID: 11210998BACKGROUND

MeSH Terms

Conditions

Obesity

Condition Hierarchy (Ancestors)

OverweightOvernutritionNutrition DisordersNutritional and Metabolic DiseasesBody WeightSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Vivian MM Suen, MD, PhD

    University of Sao Paulo

    PRINCIPAL INVESTIGATOR

  • Lauro Winchert-Ana, MD, PhD

    University of Sao Paulo

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Priscila G Fassini, PhD

CONTACT

+55 16 36022366priscilafassini@usp.br

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Professor of Internal Medicine Department at Ribeirão Preto Medical School

Study Record Dates

First Submitted

March 5, 2021

First Posted

March 24, 2021

Study Start

April 1, 2021

Primary Completion

November 1, 2021

Study Completion

November 1, 2021

Last Updated

March 24, 2021

Record last verified: 2021-03

Data Sharing

IPD Sharing
Will not share

Locations

BR(1)