NCT05026411

Brief Summary

It has been described in obese individuals in which decreased basal metabolism as well as dopaminergic changes in the prefrontal cortex and striatum parallels the increased activation of reward brain regions in response to delicious food cues. Our aim is to explore different neurobehavioral dimensions of food choices and motivational processes in the light of this information, and to reveal whether these behaviors can be changed by operant conditioning with neuroimaging methods for phenotypes at risk.

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
20

participants targeted

Target at below P25 for not_applicable

Timeline
Completed

Started Sep 2019

Typical duration for not_applicable

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

Study Start

First participant enrolled

September 1, 2019

Completed
1.6 years until next milestone

First Submitted

Initial submission to the registry

April 1, 2021

Completed
5 months until next milestone

First Posted

Study publicly available on registry

August 30, 2021

Completed
7 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

April 1, 2022

Completed
7 months until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2022

Completed
Last Updated

August 30, 2021

Status Verified

August 1, 2021

Enrollment Period

2.6 years

First QC Date

April 1, 2021

Last Update Submit

August 23, 2021

Conditions

Eating DisordersEating BehaviorEating HabitOrthodontic Appliance Complication

Outcome Measures

Primary Outcomes (8)

  • T0 -T1 DTMR fractional anisotropy change

    The microstructural changes in axonal and myelin structures in the tracts of the selected appetite and satiety centers in the brain will be defined. Fractional anisotropy, apparent diffusion coefficient, mean diffusivity and radial diffusivity parameters from different localizations will be measured. A hierarchical cluster analysis will be performed for centers with differing tensor imaging measurement values and a heatmap will be drawn according to the measurement level, and the brain centers with the most statistically significant difference will be scored and listed. All analyzes will be presented by using open source R packages by visualizing them with the help of tables and graphs. The written codes will be made available to everyone on open source sharing pages (such as github, bitbucket)

    12 months

  • T1-T2 DTMR fractional anisotropy change

    The microstructural changes in axonal and myelin structures in the tracts of the selected appetite and satiety centers in the brain will be defined after orthodontic treatment. Fractional anisotropy parameters from different localizations will be measured. A hierarchical cluster analysis will be performed for centers with differing tensor imaging measurement values and a heatmap will be drawn according to the measurement level, and the brain centers with the most statistically significant difference will be scored and listed. All analyzes will be presented by using open source R packages by visualizing them with the help of tables and graphs. The written codes will be made available to everyone on open source sharing pages (such as github, bitbucket)

    6 months after the end of fixed orthodontic treatment

  • T0 -T1 DTMR apparent diffusion coefficient change

    The microstructural changes in axonal and myelin structures in the tracts of the selected appetite and satiety centers in the brain will be defined. Apparent diffusion coefficient parameters from different localizations will be measured. A hierarchical cluster analysis will be performed for centers with differing tensor imaging measurement values and a heatmap will be drawn according to the measurement level, and the brain centers with the most statistically significant difference will be scored and listed. All analyzes will be presented by using open source R packages by visualizing them with the help of tables and graphs. The written codes will be made available to everyone on open source sharing pages (such as github, bitbucket)

    12 months

  • T1-T2 DTMR Apparent diffusion coefficient change

    The microstructural changes in axonal and myelin structures in the tracts of the selected appetite and satiety centers in the brain will be defined after orthodontic treatment. Apparent diffusion coefficient parameters from different localizations will be measured. A hierarchical cluster analysis will be performed for centers with differing tensor imaging measurement values and a heatmap will be drawn according to the measurement level, and the brain centers with the most statistically significant difference will be scored and listed. All analyzes will be presented by using open source R packages by visualizing them with the help of tables and graphs. The written codes will be made available to everyone on open source sharing pages (such as github, bitbucket)

    6 months

  • T0 -T1 DTMR mean diffusivity change

    The microstructural changes in axonal and myelin structures in the tracts of the selected appetite and satiety centers in the brain will be defined. Mean diffusivity parameters from different localizations will be measured. A hierarchical cluster analysis will be performed for centers with differing tensor imaging measurement values and a heatmap will be drawn according to the measurement level, and the brain centers with the most statistically significant difference will be scored and listed. All analyzes will be presented by using open source R packages by visualizing them with the help of tables and graphs. The written codes will be made available to everyone on open source sharing pages (such as github, bitbucket)

    12 months

  • T1-T2 DTMR mean diffusivity change

    The microstructural changes in axonal and myelin structures in the tracts of the selected appetite and satiety centers in the brain will be defined after orthodontic treatment. Mean diffusivity change parameters from different localizations will be measured. A hierarchical cluster analysis will be performed for centers with differing tensor imaging measurement values and a heatmap will be drawn according to the measurement level, and the brain centers with the most statistically significant difference will be scored and listed. All analyzes will be presented by using open source R packages by visualizing them with the help of tables and graphs. The written codes will be made available to everyone on open source sharing pages (such as github, bitbucket)

    6 months

  • T0 -T1 DTMR Radial diffusivity change

    The microstructural changes in axonal and myelin structures in the tracts of the selected appetite and satiety centers in the brain will be defined. Radial diffusivity parameters from different localizations will be measured. A hierarchical cluster analysis will be performed for centers with differing tensor imaging measurement values and a heatmap will be drawn according to the measurement level, and the brain centers with the most statistically significant difference will be scored and listed. All analyzes will be presented by using open source R packages by visualizing them with the help of tables and graphs. The written codes will be made available to everyone on open source sharing pages (such as github, bitbucket)

    12 months

  • T1-T2 DTMR radial diffusivity change

    The microstructural changes in axonal and myelin structures in the tracts of the selected appetite and satiety centers in the brain will be defined after orthodontic treatment. Radial diffusivity parameters from different localizations will be measured. A hierarchical cluster analysis will be performed for centers with differing tensor imaging measurement values and a heatmap will be drawn according to the measurement level, and the brain centers with the most statistically significant difference will be scored and listed. All analyzes will be presented by using open source R packages by visualizing them with the help of tables and graphs. The written codes will be made available to everyone on open source sharing pages (such as github, bitbucket)

    6 months

Secondary Outcomes (4)

  • T0-T1 Dutch Eating Behaviour Questionnaire Score Change

    12 months

  • T1-T2 Dutch Eating Behaviour Questionnaire Score Change

    6 months after the end of fixed orthodontic treatment

  • T0-T1 Eating Attitude Test Score Change

    12 months

  • T1-T2 Eating Attitude Test Score Change

    6 Months

Study Arms (1)

Orthodontic patients

OTHER

Magnetic resonance images will be taken from 20 individuals with eating disorders before fixed orthodontic treatment, 12 months of orthodontic treatment and 6 months after orthodontic treatment finished

Diagnostic Test: T 0 Diffusion Tensor MRDiagnostic Test: T 1 Diffusion Tensor MRDiagnostic Test: T 2 Diffusion Tensor MR

Interventions

T 0 Diffusion Tensor MRDIAGNOSTIC_TEST

Magnetic resonance images has been taken from 20 individuals with eating disorders before fixed orthodontic treatment

Orthodontic patients
T 1 Diffusion Tensor MRDIAGNOSTIC_TEST

Magnetic resonance images will be taken from 20 individuals with eating disorders after 12 months of orthodontic treatment.

Orthodontic patients
T 2 Diffusion Tensor MRDIAGNOSTIC_TEST

Magnetic resonance images will be taken from 20 individuals with eating disorders 6 months after orthodontic treatment finished

Orthodontic patients

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • Patients thought to have emotional eating, restrained eating and external eating.
  • patients between the ages of 18-60
  • Patients with minor to moderate crowding in the mandibular and maxillary arches not exceeding 7 mm
  • Orthodontic patients who need to be treated with fixed treatment without extraction.
  • Class 1 healthy patients according to the American Society of Anesthesiologists (ASA) criteria 20 individuals selected from amongst will constitute our main sample group.

You may not qualify if:

  • Maxillary expansion apparatus, transpalatal arch, Herbst, Forsus etc. before fixed treatment. Patients who require fixed non-treatment devices such as fixed devices will not be included in the study.
  • Patients who require constant use of devices containing materials that may contain steel other than tubes and brackets as orthodontic materials will not be included.
  • Although it could not be detected at the beginning of the treatment if any of the treatment methods (extraction, etc.) other than the standardized protocol are required in the future, the patient will be excluded from the study.
  • Before the patients start orthodontic treatment, a consultation will be requested from the Department of Mental Health and Diseases and the patients who are not found suitable will be excluded from the study by the initiative of the psychiatrist who examines the patient without asking a reason for the doctor-patient confidentiality.
  • Before the patients start orthodontic treatment, a consultation will be requested from the dietician and the patients who are not found suitable will be excluded from the study by the initiative of the dietician who examines the patient without asking a reason for the doctor-patient confidentiality.
  • Before the patients start orthodontic treatment, a consultation will be requested from the internal medicine doctor if there is any doubt that there may be an organic basis for patients to have a high BMI. The patients who are not found suitable will be excluded from the study by the initiative of the internal medicine doctor who examines the patient without asking a reason for the doctor-patient confidentiality.
  • Patients using medical treatment due to a known disease before orthodontic treatment will be excluded from the study.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Banu Kilic

Istanbul, Fatih, 34844, Turkey (Türkiye)

Location

Related Publications (5)

  • Bozan N, Bas M, Asci FH. Psychometric properties of Turkish version of Dutch Eating Behaviour Questionnaire (DEBQ). A preliminary results. Appetite. 2011 Jun;56(3):564-6. doi: 10.1016/j.appet.2011.01.025. Epub 2011 Jan 26.

    PMID: 21277923BACKGROUND

  • Kroemer NB, Small DM. Fuel not fun: Reinterpreting attenuated brain responses to reward in obesity. Physiol Behav. 2016 Aug 1;162:37-45. doi: 10.1016/j.physbeh.2016.04.020. Epub 2016 Apr 13.

    PMID: 27085908BACKGROUND

  • Alkan A, Sahin I, Keskin L, Cikim AS, Karakas HM, Sigirci A, Erdem G. Diffusion-weighted imaging features of brain in obesity. Magn Reson Imaging. 2008 May;26(4):446-50. doi: 10.1016/j.mri.2007.10.004. Epub 2007 Dec 11.

    PMID: 18063337BACKGROUND

  • Garcia-Garcia I, Horstmann A, Jurado MA, Garolera M, Chaudhry SJ, Margulies DS, Villringer A, Neumann J. Reward processing in obesity, substance addiction and non-substance addiction. Obes Rev. 2014 Nov;15(11):853-69. doi: 10.1111/obr.12221. Epub 2014 Sep 29.

    PMID: 25263466BACKGROUND

  • Sergl HG, Klages U, Zentner A. Pain and discomfort during orthodontic treatment: causative factors and effects on compliance. Am J Orthod Dentofacial Orthop. 1998 Dec;114(6):684-91. doi: 10.1016/s0889-5406(98)70201-x.

    PMID: 9844209BACKGROUND

MeSH Terms

Conditions

Feeding and Eating DisordersFeeding Behavior

Condition Hierarchy (Ancestors)

Signs and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and SymptomsMental DisordersBehavior, AnimalBehavior

Study Officials

  • Banu Kılıç

    Bezmialem Vakif University

    STUDY DIRECTOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Masking Details
The radiologist will be blinded to who the films are from and at what stage of the treatment they were taken.
Purpose
DIAGNOSTIC
Intervention Model
SINGLE GROUP
Model Details: Diffusion tensor imagings will be taken from the patients at the beginning of the orthodontic treatment, in the first year of treatment and 6 months after the treatment ends.
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Assistant Professor

Study Record Dates

First Submitted

April 1, 2021

First Posted

August 30, 2021

Study Start

September 1, 2019

Primary Completion

April 1, 2022

Study Completion

November 1, 2022

Last Updated

August 30, 2021

Record last verified: 2021-08

Data Sharing

IPD Sharing
Will not share

Locations

TU(1)