Genetic Causes of Gestational Diabetes in the Emirati Population

Gestational Diabetes Clinical Trial

Official title:

Genetic Causes of Gestational Diabetes in the Emirati Population

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT03589092
• Other study ID #: IREC032
• Status: Recruiting
• Start date: January 1, 2017
• Est. completion date: December 31, 2020

Study information

• Verified date: June 2020
• Source: Imperial College London Diabetes Centre
• Contact: Hinda Daggag, PhD
• Phone: +971 2 404 0800
• Email: hdaggag[@]icldc.ae
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The study aims to identify the number of MODY patients to be found among Emirati women with GDM as the incidence and prevalence of monogenic diabetes among this group of patients is unknown. This will enable improvements in diagnostics, treatment and the counselling of these women.

Description:

The present study aims to perform systematic genetic screening of genes known as the cause of MODY in women diagnosed with gestational diabetes to estimate the prevalence of MODY. This is important to understand the extent to which monogenic diabetes is encountered for the first time during pregnancy. Once women with MODY developing GDM have been identified, biomarkers to identify these women can be found which will assist the clinical process of performing genetic screening in the right subset of patients. Also for the women participating in the present study, this is of great importance as correct genetic diagnosis will provide them with the needed information to receive optimal treatment, correct plan for follow-up and a more accurate prognosis in relation to risk of future complication and therefore prevention of such.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 600
• Est. completion date: December 31, 2020
• Est. primary completion date: December 31, 2020
• Accepts healthy volunteers: No
• Gender: Female
• Age group: 18 Years to 50 Years

Eligibility

Inclusion Criteria:

• Currently pregnant women diagnosed with GDM.

• Women with history of GDM (with negative GAD/IA2 antibodies if results available).

Exclusion Criteria:

• Women with positive GAD/IA2 antibodies (if results available)

• Women genetically diagnosed as MODY

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Diabetes, Gestational
• GDM
• Gestational Diabetes
• Maturity-onset Diabetes of the Young
• MODY

Intervention

Genetic:
• Next generation sequencing (NGS)
NGS Panel, Whole exome/genome sequencing

Locations

Country	Name	City	State
United Arab Emirates	Imperial College London Diabetes Centre	Abu Dhabi

Sponsors (1)

Lead Sponsor	Collaborator
Imperial College London Diabetes Centre

Country where clinical trial is conducted

United Arab Emirates, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	GDM Identification	Identifying individuals with history of GDM or current diagnosis of GDM and analysing their GTT results and likelihood of MODY. GTT results will be extracted from patient's medical records.	through study completion, an average of 2 year
Secondary	Next Generation Sequencing (NGS)	Next Generation Sequencing (NGS) technology will be applied to perform genetic testing, analysing 13 previously published MODY genes and potentially identifying novel causative mutations.	through study completion, an average of 2 year
Secondary	Novel diabetes genes	Identifying novel diabetes genes in the Emirati women with GDM by performing whole exome sequencing.	through study completion, an average of 2 year
Secondary	Genetic test results validation	Validating positive genetic test results by performing mutational analysis on parental, siblings and relatives samples. Request from parents, siblings and/or relatives to participate in the study will only occur if a novel (potentially pathogenic mutation) is identified and the primary participant agrees to it.	through study completion, an average of 2 year
Secondary	Potential biomarkers	Identifying potential biomarkers in women with MODY and who are developing GDM, to assist the selection of women suitable for genetic screening.	through study completion, an average of 2 year
Secondary	Prevalence of MODY	Determining the prevalence of MODY in women with GDM in the UAE.	through study completion, an average of 2 year
Secondary	Clinical outcomes determination	Determining the short and the long-term clinical outcomes of MODY in women with GDM in the UAE	through study completion, an average of 2 year