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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT04786054
Other study ID # BEDCAI37628
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date January 1, 2019
Est. completion date February 1, 2021

Study information

Verified date March 2021
Source Corporacion Parc Tauli
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical 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 females in Pakistan, South Asia.


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.


Recruitment information / eligibility

Status Completed
Enrollment 91
Est. completion date February 1, 2021
Est. primary completion date January 1, 2021
Accepts healthy volunteers No
Gender Female
Age group 10 Years to 19 Years
Eligibility 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 Design


Intervention

Diagnostic Test:
BED Questionnaire
BED Questionnaire

Locations

Country Name City State
Pakistan Zainab Khan Lahore Punjab

Sponsors (1)

Lead Sponsor Collaborator
Corporacion Parc Tauli

Country where clinical trial is conducted

Pakistan, 

Outcome

Type Measure Description Time frame Safety issue
Primary BED Presence of BED detected by individuals who score high on the BEDS7 Questionnaire administered Baseline
Secondary 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
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