Genetic Association of Glucocorticoid Receptor Gene Polymorphisms With Binge Eating

Sponsor

Corporacion Parc Tauli (Other)

Overall Status

Completed

CT.gov ID

NCT04786054

Collaborator

(none)

Enrollment

Location

Arms

Actual Duration (Months)

3.6

Patients Per Site Per Month

Study Details

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.

Condition or Disease	Intervention/Treatment	Phase
Binge-Eating Disorder Eating Disorders Obesity Diabetes Type 2 Adolescent Behavior	Diagnostic Test: BED Questionnaire	N/A

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

Study Type:

Interventional

Actual Enrollment :

91 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Screening

Official Title:

Genetic Association of Glucocorticoid Receptor Gene Polymorphisms With Binge Eating Disorders in Type 2 Diabetic Obese Female Adolescents

Actual Study Start Date :

Jan 1, 2019

Actual Primary Completion Date :

Jan 1, 2021

Actual Study Completion Date :

Feb 1, 2021

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Group BED Those who are diagnosed with having Binge Eating disorder. These individuals qualified after the questionnaire was administered.	Diagnostic Test: BED Questionnaire BED Questionnaire
No Intervention: Group Non-BED Those who are not diagnosed with having Binge Eating disorder

Arm

Intervention/Treatment

Active Comparator: Group BED

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

Diagnostic Test: BED Questionnaire

BED Questionnaire

No Intervention: Group Non-BED

Those who are not diagnosed with having Binge Eating disorder

Outcome Measures

Primary Outcome Measures

BED [Baseline]
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) [Six months into the study after identifying all individuals who scored high on the BEDS7 Questionnaire]
Presence of variants of the GR gene (rs56149945; rs41423247)

Eligibility Criteria

Criteria

Ages Eligible for Study:

10 Years to 19 Years

Sexes Eligible for Study:

Female

Accepts 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

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Zainab Khan	Lahore	Punjab	Pakistan

Sponsors and Collaborators

Corporacion Parc Tauli

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Dr Zainab Khan, Chief Resident, Corporacion Parc Tauli

ClinicalTrials.gov Identifier:

NCT04786054

Other Study ID Numbers:

BEDCAI37628

First Posted:

Mar 8, 2021

Last Update Posted:

Mar 9, 2021

Last Verified:

Mar 1, 2021

Individual Participant Data (IPD) Sharing Statement:

Plan to Share IPD:

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Diabetes Mellitus, Type 2

Disease

Bulimia

Feeding and Eating Disorders

Binge-Eating Disorder

Study Results

No Results Posted as of Mar 9, 2021