Genetic Association of Glucocorticoid Receptor Gene Polym... | NCT04786054

Studies
Genetic Association of Glucocorticoid Receptor Gene Polymorphisms With Binge Eating

NCT04786054

Sponsor

Corporacion Parc Tauli

Status

Completed

Last Update Posted

Mar 9, 2021Actual

Enrollment

91Actual

Phase

Not Applicable

Conditions

Binge-Eating Disorder
Eating Disorders
Obesity
Diabetes Type 2
Adolescent Behavior

Interventions

BED Questionnaire

Countries

Pakistan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2021

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jan 1, 2019Actual

Primary Completion Date

Jan 1, 2021Actual

Completion Date

Feb 1, 2021Actual

First Submitted Date

Feb 26, 2021

First Submission Date that Met QC Criteria

Mar 3, 2021

First Posted Date

Mar 8, 2021Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Mar 7, 2021

Last Update Posted Date

Mar 9, 2021Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Not Applicable

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

91Actual

Arms/Interventions Module

Arm Groups

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

Interventions

Name	Type	Description	Arm Group Labels	Other Names
BED Questionnaire	Diagnostic Test	BED Questionnaire	Group BED

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Measure	Description	Time Frame
NR3C1 Presence of variants of the GR gene (rs56149945; rs41423247)	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

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

Female

Sex/Gender Based

Yes

Sex/Gender Description

Biological female

Minimum Age

10 Years

Maximum Age

19 Years

Standard Ages

ChildAdult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Zainab Khan		Lahore	Punjab Province		Pakistan

IPD Sharing Statement Module

Plan to Share IPD

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D056912	Binge-Eating Disorder
D001068	Feeding and Eating Disorders
D009765	Obesity
D003924	Diabetes Mellitus, Type 2
D000294	Adolescent Behavior

Ancestor Terms

ID	Term
D001523	Mental Disorders
D012817	Signs and Symptoms, Digestive
D012816	Signs and Symptoms
D013568	Pathological Conditions, Signs and Symptoms

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