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Genetic Association of Glucocorticoid Receptor Gene Polymorphisms With Binge Eating

Primary Purpose

Binge-Eating Disorder, Eating Disorders, Obesity

Status
Completed
Phase
Not Applicable
Locations
Pakistan
Study Type
Interventional
Intervention
BED Questionnaire
Sponsored by
Corporacion Parc Tauli
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional screening trial for Binge-Eating Disorder

Eligibility Criteria

10 Years - 19 Years (Child, Adult)FemaleDoes not accept healthy volunteers

Inclusion Criteria:

  • 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).

Exclusion Criteria:

  • Presence of psychosis, major psychiatric or neurocognitive disorder
  • Substance use
  • Untreated attention-deficit hyperactivity disorder
  • Use of psychopharmacological medications or psychotherapy
  • Class III obesity

Sites / Locations

  • Zainab Khan

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

Group BED

Group Non-BED

Arm Description

Those who are diagnosed with having Binge Eating disorder. These individuals qualified after the questionnaire was administered.

Those who are not diagnosed with having Binge Eating disorder

Outcomes

Primary Outcome Measures

BED
Presence of BED detected by individuals who score high on the BEDS7 Questionnaire administered

Secondary Outcome Measures

NR3C1 Presence of variants of the GR gene (rs56149945; rs41423247)
Presence of variants of the GR gene (rs56149945; rs41423247)

Full Information

First Posted
February 26, 2021
Last Updated
March 7, 2021
Sponsor
Corporacion Parc Tauli
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1. Study Identification

Unique Protocol Identification Number
NCT04786054
Brief Title
Genetic Association of Glucocorticoid Receptor Gene Polymorphisms With Binge Eating
Official Title
Genetic Association of Glucocorticoid Receptor Gene Polymorphisms With Binge Eating Disorders in Type 2 Diabetic Obese Female Adolescents
Study Type
Interventional

2. Study Status

Record Verification Date
March 2021
Overall Recruitment Status
Completed
Study Start Date
January 1, 2019 (Actual)
Primary Completion Date
January 1, 2021 (Actual)
Study Completion Date
February 1, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Corporacion Parc Tauli

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. Study Description

Brief 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 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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Binge-Eating Disorder, Eating Disorders, Obesity, Diabetes Type 2, Adolescent Behavior

7. Study Design

Primary Purpose
Screening
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
91 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Group BED
Arm Type
Active Comparator
Arm Description
Those who are diagnosed with having Binge Eating disorder. These individuals qualified after the questionnaire was administered.
Arm Title
Group Non-BED
Arm Type
No Intervention
Arm Description
Those who are not diagnosed with having Binge Eating disorder
Intervention Type
Diagnostic Test
Intervention Name(s)
BED Questionnaire
Intervention Description
BED Questionnaire
Primary Outcome Measure Information:
Title
BED
Description
Presence of BED detected by individuals who score high on the BEDS7 Questionnaire administered
Time Frame
Baseline
Secondary Outcome Measure Information:
Title
NR3C1 Presence of variants of the GR gene (rs56149945; rs41423247)
Description
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

10. Eligibility

Sex
Female
Gender Based
Yes
Gender Eligibility Description
Biological female
Minimum Age & Unit of Time
10 Years
Maximum Age & Unit of Time
19 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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). Exclusion Criteria: Presence of psychosis, major psychiatric or neurocognitive disorder Substance use Untreated attention-deficit hyperactivity disorder Use of psychopharmacological medications or psychotherapy Class III obesity
Facility Information:
Facility Name
Zainab Khan
City
Lahore
State/Province
Punjab
Country
Pakistan

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Genetic Association of Glucocorticoid Receptor Gene Polymorphisms With Binge Eating

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