Binge-Eating DisorderNCT04786054
Genetic Association of Glucocorticoid Receptor Gene Polymorphisms With Binge Eating
A study testing BED Questionnaire in people with Binge-Eating Disorder and Eating Disorders, run by Corporacion Parc Tauli at 1 site in Pakistan.
Trial summary
The aim of the present study was to specifically screen obese diabetic adolescent female individuals for BED, checking the variants of the GR gene (rs56149945; rs41423247) amongst identified individuals, and this led to assessing the impact of binge eating disorders on glycaemic control in obese diabetic adolescent… Read more about this study
- Who is it for?
- Ages 10 to 19 years, women only
- Conditions the study is for
- Binge-Eating Disorder, Eating Disorders, Obesity
- What is being tested?
- BED Questionnaire
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 91 participants
- Where
- 1 sitePakistan
- Study dates
- 1 Jan 2019to 1 Feb 2021
- 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 10 to 19 years
- Women only
- No healthy volunteers
- Child, Adult
Who may be able to join
- Unmarried females diagnosed with Type 2 diabetes > 12 months
- Age 10-19 years
- Obesity class I and II (based on BMI range of 30 - 40).
Who cannot join
- Presence of psychosis, major psychiatric or neurocognitive disorder
- Substance use
- Untreated attention-deficit hyperactivity disorder
- Use of psychopharmacological medications or psychotherapy
- Class III obesity
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Genetic Association of Glucocorticoid Receptor Gene Polymorphisms With Binge Eating Disorders in Type 2 Diabetic Obese Female Adolescents
The aim of the present study was to specifically screen obese diabetic adolescent female individuals for BED, checking the variants of the GR gene (rs56149945; rs41423247) amongst identified individuals, and this led to assessing the impact of binge eating disorders on glycaemic control in obese diabetic adolescent females in Pakistan, South Asia.
Read the detailed description
Challenges in eating for diabetic adolescents can be categorized as eating disorders (ED) and disordered eating symptoms (DES). Binge-eating disorder (BED) is defined as recurrent episodes of binge eating at least once a week over a three-month time period and it is accompanied by feeling the lack of control and marked distress over one's eating behaviour. The aim of the present study was to specifically screen obese diabetic adolescent female individuals for BED, checking the variants of the GR gene (rs56149945; rs41423247) amongst identified individuals, and this led to assessing the impact of binge eating disorders on glycaemic control in obese diabetic adolescent females in Pakistan, South Asia.
- Being tested
- BED Questionnaire
- Medical subject headings
- Binge-Eating Disorder, Feeding and Eating Disorders, Obesity, Diabetes Mellitus, Type 2, Adolescent Behavior
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
BED QuestionnaireDiagnostic test
BED Questionnaire
| Study group | Role | What they receive |
|---|---|---|
| Group BED | Active comparator | Those who are diagnosed with having Binge Eating disorder. These individuals qualified after the questionnaire was administered. Receives: Diagnostic Test: BED Questionnaire |
| Group Non-BED | No intervention | Those who are not diagnosed with having Binge Eating disorder |
What is being measured
The primary outcome is the main question the study is designed to answer.
BED
Presence of BED detected by individuals who score high on the BEDS7 Questionnaire administered
Measured: Baseline
Secondary outcomes (1)
NR3C1 Presence of variants of the GR gene (rs56149945; rs41423247)
Presence of variants of the GR gene (rs56149945; rs41423247)
Measured: Six months into the study after identifying all individuals who scored high on the BEDS7 Questionnaire
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted8 Mar 2021
- Study start1 Jan 2019
- Primary completion1 Jan 2021
- Study completion1 Feb 2021
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Binge-Eating DisorderStudies of the same condition, open and under way.
- 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
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 91 participants (actual)
Sponsor and investigators
- Lead sponsor
- Corporacion Parc Tauli
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Zainab Khan, Corporacion Parc Tauli
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04786054
- Sponsor's protocol ID
- BEDCAI37628
- Status last verified
- Mar 2021
- First submitted
- 26 Feb 2021
- Last updated
- 9 Mar 2021
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Mar 2021. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genetic Association of Glucocorticoid Receptor Gene Polymorphisms With Binge Eating Disorders in Type 2 Diabetic Obese Female Adolescents
- ClinicalTrials.gov ID
- NCT04786054
- Acronym / sponsor ID
- BEDCAI37628
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 91 participants (actual)
- Lead sponsor
- Corporacion Parc TauliUniversity, hospital or other
- Study start
- 1 Jan 2019 (actual)
- Primary completion
- 1 Jan 2021 (actual)
- Study completion
- 1 Feb 2021 (actual)
- First posted
- 8 Mar 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.
The aim of the present study was to specifically screen obese diabetic adolescent female individuals for BED, checking the variants of the GR gene (rs56149945; rs41423247) amongst identified individuals, and this led to assessing the impact of binge eating disorders on glycaemic control in obese diabetic adolescent females in Pakistan, South Asia.
Detailed description
Challenges in eating for diabetic adolescents can be categorized as eating disorders (ED) and disordered eating symptoms (DES). Binge-eating disorder (BED) is defined as recurrent episodes of binge eating at least once a week over a three-month time period and it is accompanied by feeling the lack of control and marked distress over one's eating behaviour. The aim of the present study was to specifically screen obese diabetic adolescent female individuals for BED, checking the variants of the GR gene (rs56149945; rs41423247) amongst identified individuals, and this led to assessing the impact of binge eating disorders on glycaemic control in obese diabetic adolescent females in Pakistan, South Asia.
Study design
- Primary purpose
- Screening
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Group BED | Active comparator | Diagnostic Test: BED QuestionnaireThose who are diagnosed with having Binge Eating disorder. These individuals qualified after the questionnaire was administered. |
| Group Non-BED | No intervention | –Those who are not diagnosed with having Binge Eating disorder |
Who may qualify
- Ages
- 10 to 19 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (3 listed)
- Unmarried females diagnosed with Type 2 diabetes > 12 months
- Age 10-19 years
- Obesity class I and II (based on BMI range of 30 - 40).
Key exclusion criteria (5 listed)
- Presence of psychosis, major psychiatric or neurocognitive disorder
- Substance use
- Untreated attention-deficit hyperactivity disorder
- Use of psychopharmacological medications or psychotherapy
- Class III obesity
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 |
|---|---|---|
| BED QuestionnaireBED Questionnaire | Diagnostic test | Group BED |
Primary outcome
BED
Time frame: Baseline
Presence of BED detected by individuals who score high on the BEDS7 Questionnaire administered
1 secondary outcome
NR3C1 Presence of variants of the GR gene (rs56149945; rs41423247)
Time frame: Six months into the study after identifying all individuals who scored high on the BEDS7 Questionnaire
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Mar 2021.
- Individual participant dataSharing planned: No
Related trials for Binge-Eating Disorder
Not yet recruiting
Be Body Brave: Digital Written Exposure Therapy for Eating Disorders
Eating Disorders
Enrolling by invitationPhase 3
A Study to Assess the Long-term Safety and Efficacy of Solriamfetol in Subjects With Binge Eating Disorder
Binge-Eating Disorder
Not yet recruiting
Effectiveness of a 10-week Multicomponent Intervention Combined With Parent Education on Binge Eating Behavior in Children and Adolescents
Binge Eating Disorder, Binge Eating
Enrolling by invitation
Sleep and Activity For Eating Disorders
Eating Disorders, Anorexia Nervosa
Active, not recruiting
Project VIBE: Virtual Intervention for Binge Eating in Adolescents
Obesity, Binge-Eating Disorder
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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing BED Questionnaire in people with Binge-Eating Disorder and Eating Disorders, run by Corporacion Parc Tauli at 1 site in Pakistan.
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 3 inclusion and 5 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: finished, as of the sponsor's last update on 9 Mar 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 Pakistan. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
BED (time frame: Baseline). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 9 Mar 2021.