Genetic Causes of Gestational Diabetes in the Emirati Population

• Conditions: GDM; Gestational Diabetes; Maturity-onset Diabetes of the Young; MODY
• Interventions: Genetic: Next generation sequencing (NGS)

• Registration Number: NCT03589092
• Lead Sponsor: Imperial College London Diabetes Centre

Brief 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.

Detailed 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.

Study Timeline

• Study Start: 2017-01-01
• Study First Submitted: 2018-07-02
• Study First Submitted QC: 2018-07-16
• Study First Posted: 2018-07-17
• Status Verified: 2020-06
• Last Update Submitted: 2020-06-24
• Last Update Posted: 2020-06-25
• Primary Completion: 2020-12-31
• Study Completion: 2020-12-31

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: Female
• Target Recruitment: 600

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

Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Arm && Interventions

Group	Intervention	Description
GDM Current	Next generation sequencing (NGS)	Currently pregnant women diagnosed with GDM. Next generation sequencing (NGS) methodologies will used on individuals suspected of genetic diabetes.
GDM History	Next generation sequencing (NGS)	Women with history of GDM (with negative GAD/IA2 antibodies if results available). Next generation sequencing (NGS) methodologies will used on individuals suspected of genetic diabetes.

Primary Outcome Measures

Name	Time	Method
GDM Identification	through study completion, an average of 2 year	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.

Secondary Outcome Measures

Name	Time	Method
Prevalence of MODY	through study completion, an average of 2 year	Determining the prevalence of MODY in women with GDM in the UAE.
Next Generation Sequencing (NGS)	through study completion, an average of 2 year	Next Generation Sequencing (NGS) technology will be applied to perform genetic testing, analysing 13 previously published MODY genes and potentially identifying novel causative mutations.
Genetic test results validation	through study completion, an average of 2 year	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.
Potential biomarkers	through study completion, an average of 2 year	Identifying potential biomarkers in women with MODY and who are developing GDM, to assist the selection of women suitable for genetic screening.
Novel diabetes genes	through study completion, an average of 2 year	Identifying novel diabetes genes in the Emirati women with GDM by performing whole exome sequencing.
Clinical outcomes determination	through study completion, an average of 2 year	Determining the short and the long-term clinical outcomes of MODY in women with GDM in the UAE

Trial Locations

Locations (1)

Imperial College London Diabetes Centre; 🇦🇪 Abu Dhabi, United Arab Emirates