Genetic Causes of Gestational Diabetes in the Emirati Population

NCT ID: NCT03589092

Last Updated: 2020-06-25

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

600 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-01-01

Study Completion Date

2020-12-31

Brief Summary

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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

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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.

Conditions

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Gestational Diabetes GDM Maturity-onset Diabetes of the Young MODY

Study Design

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Observational Model Type

COHORT

Study Time Perspective

CROSS_SECTIONAL

Study Groups

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GDM Current

Currently pregnant women diagnosed with GDM.

Next generation sequencing (NGS) methodologies will used on individuals suspected of genetic diabetes.

Next generation sequencing (NGS)

Intervention Type GENETIC

NGS Panel, Whole exome/genome sequencing

GDM History

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.

Next generation sequencing (NGS)

Intervention Type GENETIC

NGS Panel, Whole exome/genome sequencing

Interventions

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Next generation sequencing (NGS)

NGS Panel, Whole exome/genome sequencing

Intervention Type GENETIC

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

50 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

No

Sponsors

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Imperial College London Diabetes Centre

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Maha Barakat, PhD FRCP

Role: PRINCIPAL_INVESTIGATOR

Imperial College London Diabetes Centre

Torben Hansen, MD PhD

Role: PRINCIPAL_INVESTIGATOR

University of Copenhagen

Locations

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Imperial College London Diabetes Centre

Abu Dhabi, , United Arab Emirates

Site Status RECRUITING

Countries

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United Arab Emirates

Central Contacts

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Hinda Daggag, PhD

Role: CONTACT

+971 2 404 0800

Facility Contacts

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Hinda Daggag, PhD

Role: primary

+971 2 404 0800

Other Identifiers

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IREC032

Identifier Type: -

Identifier Source: org_study_id

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