Eating DisordersDTINCT05026411
Food Reward Circuit Change by Orthodontics
A study testing T 0 Diffusion Tensor MR, T 1 Diffusion Tensor MR and T 2 Diffusion Tensor MR in people with Eating Disorders and Eating Behavior, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 60 yearsHealthy volunteers can take part
- Conditions the study is for
- Eating Disorders, Eating Behavior, Eating Habit
- What is being tested?
- T 0 Diffusion Tensor MR, T 1 Diffusion Tensor MR and T 2 Diffusion Tensor MR
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 20 participants
- Where
- 1 siteTurkey (Türkiye)
- Study dates
- 1 Sep 2019to 1 Nov 2022
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 60 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Assessment of Food Reward Circuit Change in Individuals Receiving Orthodontic Treatment With Diffusion Tensor Imaging
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.
Read the detailed description
The incidence of eating disorders in society is increasing day by day and is becoming an increasingly serious problem. Overweight people are suggested to exhibit eating behavior to cope with anxiety, depressed mood, anger and other negative emotions. Studies in humans and animals have shown that obesity is associated with changes in dopaminergic neurotransmission. Changes in brain locations associated with satiety and hunger centers (hypothalamus, hippocampal gyrus, amygdala, insula, cerebellum and midbrain) of obese patients have been shown. It has been reported that cognitive control strategies that can lead to more effective impulse control behaviors should be applied for obesity treatment, which is considered as an addiction in which food is perceived as a reward nowadays.
During the first week of fixed orthodontic treatment, all the patients have pain and various discomforts with food, and after each appointment, the pain occurs while chewing. Patients declare having prolonged eating times due to difficulty in chewing, food impaction under the brackets and complains about not being able to consume sugar-containing foods due to maintain oral hygen. It is known that individuals who have eating disorders have a disturbance in their food rewarding properties and eating behavior. They eat in response to emotions rather than to meet energy needs. Pharmacological and bariatric surgical interventions are more successful than dietary lifestyle interventions because these interventions reduced not only the hunger but also the reward value of the homeostatic and hedonic brain regions of the foods. However, there is no study of whether enjoying from the food, perceiving food as a reward or individuals eating habits can be changed. The hypothesis of this study is that as a result of orthodontic treatment in which individuals experience negative emotions during each meal for two years there will be a change in the way of individuals' interpretation of food.
In order to investigate this hypothesis, eating attitudes and eating habit questionnaires will be applied to healthy volunteers with a body mass index of 25 and above chosen from patients who applied to our clinic for fixed orthodontic treatment. Thus, individuals with emotional eating, externally induced eating, restrained eating disorders and eating habits of these individuals will be identified. 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. By means of magnetic resonance imaging (MRI) and diffusion tensor imaging (DTG), the microstructural changes in axonal and myelin structures in the tracts of the selected appetite and satiety centers in the brain will be defined. The presence of changes by the orthodontic treatment in nutritional perceptions will be measured.
- Being tested
- T 0 Diffusion Tensor MR, T 1 Diffusion Tensor MR, T 2 Diffusion Tensor MR
- Medical subject headings
- Feeding and Eating Disorders, Feeding Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
T 0 Diffusion Tensor MRDiagnostic test
Magnetic resonance images has been taken from 20 individuals with eating disorders before fixed orthodontic treatment
T 1 Diffusion Tensor MRDiagnostic test
Magnetic resonance images will be taken from 20 individuals with eating disorders after 12 months of orthodontic treatment.
T 2 Diffusion Tensor MRDiagnostic test
Magnetic resonance images will be taken from 20 individuals with eating disorders 6 months after orthodontic treatment finished
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: Diagnostic Test: T 0 Diffusion Tensor MR; Diagnostic Test: T 1 Diffusion Tensor MR; Diagnostic Test: T 2 Diffusion Tensor MR |
What is being measured
The primary outcome is the main question the study is designed to answer.
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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 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)
Measured: 6 months
Secondary outcomes (4)
T0-T1 Dutch Eating Behaviour Questionnaire Score Change
33 items, which measures emotional (13 items), external, and restrained eating (both 10 items) rated on a five-point scale from 1 (never) to 5 (very often) will be evaluated.
The presence of changes at eating behaviour by the orthodontic treatment in nutritional perceptions will be measured. A decrease in DEBQ scores will be perceived as a positive improvement.
Measured: 12 months
T1-T2 Dutch Eating Behaviour Questionnaire Score Change
33 items, which measures emotional (13 items), external, and restrained eating (both 10 items) rated on a five-point scale from 1 (never) to 5 (very often) will be evaluated.
If there is a presence of changes at eating behavior by the orthodontic treatment we will be able to measure if they are stable or not. A decrease in DEBQ scores or a stabilization of the dropped score will be perceived as a positive development.
Measured: 6 months after the end of fixed orthodontic treatment
T0-T1 Eating Attitude Test Score Change
It includes 40 items in which the frequencies of attitudes and beliefs are rated using 6-point scale. A score of 30 and above is commonly used as a cut-off point to identify individuals with anorexia or bulimia. The presence of changes at eating attitude by the orthodontic treatment in nutritional perceptions will be measured. A decrease in Eating Attitude Test scores will be perceived as a positive development.
Measured: 12 months
T1-T2 Eating Attitude Test Score Change
It includes 40 items in which the frequencies of attitudes and beliefs are rated using 6-point scale. A score of 30 and above is commonly used as a cut-off point to identify individuals with anorexia or bulimia. If there is a presence of changes at eating attitude by the orthodontic treatment we will be able to measure if they are stable or not. Eating Attitude Test scors falling or remaining stable will be perceived as a positive development.
Measured: 6 Months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Aug 2021
- Study start1 Sep 2019
- Primary completion1 Apr 2022 (estimated)
- Study completion1 Nov 2022 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for Eating DisordersStudies of the same condition, open and under way.
- More trials run by Bezmialem Vakif UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Model description
- 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.
- Masking
- None (open label)
- Enrolment
- 20 participants (actual)
Sponsor and investigators
- Lead sponsor
- Bezmialem Vakif University
- Sponsor type
- University, hospital or other
- Collaborators
- Muğla Sıtkı Koçman University, The Scientific and Technological Research Council of Turkey, Balikli greek hospital foundation
- Responsible party
- Principal investigator, Banu Kılıç, Bezmialem Vakif University
- Investigators
- Banu Kılıç, Study director, Bezmialem Vakif University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05026411
- Sponsor's protocol ID
- bkilic002
- Other IDs
- 119S125
- Acronym
- DTI
- Status last verified
- Aug 2021
- First submitted
- 1 Apr 2021
- Last updated
- 30 Aug 2021
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 21277923Kroemer 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.
PubMed 27085908Alkan 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.
PubMed 18063337Garcia-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.
PubMed 25263466Sergl 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.
PubMed 9844209
Study at a glance
From the registry record, last updated by the sponsor on 30 Aug 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Assessment of Food Reward Circuit Change in Individuals Receiving Orthodontic Treatment With Diffusion Tensor Imaging
- ClinicalTrials.gov ID
- NCT05026411
- Acronym / sponsor ID
- DTI / bkilic002
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 20 participants (actual)
- Lead sponsor
- Bezmialem Vakif UniversityUniversity, hospital or other
- Collaborators
- Muğla Sıtkı Koçman University, The Scientific and Technological Research Council of Turkey, Balikli greek hospital foundation
- Study start
- 1 Sep 2019 (actual)
- Primary completion
- 1 Apr 2022 (estimated)
- Study completion
- 1 Nov 2022 (estimated)
- First posted
- 30 Aug 2021 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
The incidence of eating disorders in society is increasing day by day and is becoming an increasingly serious problem. Overweight people are suggested to exhibit eating behavior to cope with anxiety, depressed mood, anger and other negative emotions. Studies in humans and animals have shown that obesity is associated with changes in dopaminergic neurotransmission. Changes in brain locations associated with satiety and hunger centers (hypothalamus, hippocampal gyrus, amygdala, insula, cerebellum and midbrain) of obese patients have been shown. It has been reported that cognitive control strategies that can lead to more effective impulse control behaviors should be applied for obesity treatment, which is considered as an addiction in which food is perceived as a reward nowadays.
During the first week of fixed orthodontic treatment, all the patients have pain and various discomforts with food, and after each appointment, the pain occurs while chewing. Patients declare having prolonged eating times due to difficulty in chewing, food impaction under the brackets and complains about not being able to consume sugar-containing foods due to maintain oral hygen. It is known that individuals who have eating disorders have a disturbance in their food rewarding properties and eating behavior. They eat in response to emotions rather than to meet energy needs. Pharmacological and bariatric surgical interventions are more successful than dietary lifestyle interventions because these interventions reduced not only the hunger but also the reward value of the homeostatic and hedonic brain regions of the foods. However, there is no study of whether enjoying from the food, perceiving food as a reward or individuals eating habits can be changed. The hypothesis of this study is that as a result of orthodontic treatment in which individuals experience negative emotions during each meal for two years there will be a change in the way of individuals' interpretation of food.
In order to investigate this hypothesis, eating attitudes and eating habit questionnaires will be applied to healthy volunteers with a body mass index of 25 and above chosen from patients who applied to our clinic for fixed orthodontic treatment. Thus, individuals with emotional eating, externally induced eating, restrained eating disorders and eating habits of these individuals will be identified. 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. By means of magnetic resonance imaging (MRI) and diffusion tensor imaging (DTG), the microstructural changes in axonal and myelin structures in the tracts of the selected appetite and satiety centers in the brain will be defined. The presence of changes by the orthodontic treatment in nutritional perceptions will be measured.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Orthodontic patients | Other | Diagnostic Test: T 0 Diffusion Tensor MR, Diagnostic Test: T 1 Diffusion Tensor MR, Diagnostic Test: T 2 Diffusion Tensor MRMagnetic 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 |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (7 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| T 0 Diffusion Tensor MRMagnetic resonance images has been taken from 20 individuals with eating disorders before fixed orthodontic treatment | Diagnostic test | Orthodontic patients |
| T 1 Diffusion Tensor MRMagnetic resonance images will be taken from 20 individuals with eating disorders after 12 months of orthodontic treatment. | Diagnostic test | Orthodontic patients |
| T 2 Diffusion Tensor MRMagnetic resonance images will be taken from 20 individuals with eating disorders 6 months after orthodontic treatment finished | Diagnostic test | Orthodontic patients |
Primary outcome
T0 -T1 DTMR fractional anisotropy change
Time frame: 12 months
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)
T1-T2 DTMR fractional anisotropy change
Time frame: 6 months after the end of fixed orthodontic treatment
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)
T0 -T1 DTMR apparent diffusion coefficient change
Time frame: 12 months
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)
T1-T2 DTMR Apparent diffusion coefficient change
Time frame: 6 months
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)
T0 -T1 DTMR mean diffusivity change
Time frame: 12 months
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)
T1-T2 DTMR mean diffusivity change
Time frame: 6 months
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)
T0 -T1 DTMR Radial diffusivity change
Time frame: 12 months
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)
T1-T2 DTMR radial diffusivity change
Time frame: 6 months
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)
4 secondary outcomes
T0-T1 Dutch Eating Behaviour Questionnaire Score Change
Time frame: 12 months
T1-T2 Dutch Eating Behaviour Questionnaire Score Change
Time frame: 6 months after the end of fixed orthodontic treatment
T0-T1 Eating Attitude Test Score Change
Time frame: 12 months
T1-T2 Eating Attitude Test Score Change
Time frame: 6 Months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Aug 2021.
- Background: PubMed 21277923Bozan 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.
- Background: PubMed 27085908Kroemer 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.
- Background: PubMed 18063337Alkan 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.
- Background: PubMed 25263466Garcia-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.
- Background: PubMed 9844209Sergl 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.
- Individual participant dataSharing planned: No
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Healthy Volunteer, Obestity
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Banu Kılıç study director
Bezmialem Vakif University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing T 0 Diffusion Tensor MR, T 1 Diffusion Tensor MR and T 2 Diffusion Tensor MR in people with Eating Disorders and Eating Behavior, run by Bezmialem Vakif University at 1 site in Turkey (Türkiye).
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 30 Aug 2021. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Turkey (Türkiye). Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
T0 -T1 DTMR fractional anisotropy change (time frame: 12 months). The study lists 8 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05026411, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Aug 2021.