Genetic Association of Glucocorticoid Receptor Gene Polymorphisms With Binge Eating

March 7, 2021 updated by: Dr Zainab Khan, Corporacion Parc Tauli

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

91

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Pakistan
    • Punjab
      • Lahore, Punjab, Pakistan
        • Zainab Khan

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

10 years to 19 years (ADULT, CHILD)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: SCREENING
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
BED
Time Frame: Baseline
Presence of BED detected by individuals who score high on the BEDS7 Questionnaire administered
Baseline

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Corporacion Parc Tauli

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2019

Primary Completion (ACTUAL)

January 1, 2021

Study Completion (ACTUAL)

February 1, 2021

Study Registration Dates

First Submitted

February 26, 2021

First Submitted That Met QC Criteria

March 3, 2021

First Posted (ACTUAL)

March 8, 2021

Study Record Updates

Last Update Posted (ACTUAL)

March 9, 2021

Last Update Submitted That Met QC Criteria

March 7, 2021

Last Verified

March 1, 2021

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • BEDCAI37628

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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