Genetic Causes of Gestational Diabetes in the Emirati Population

June 24, 2020 updated by: Imperial College London Diabetes Centre
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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 Type

Observational

Enrollment (Anticipated)

600

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • United Arab Emirates
      • Abu Dhabi, United Arab Emirates, 48338
        • Recruiting
        • Imperial College London Diabetes Centre

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 50 years (ADULT)

Accepts Healthy Volunteers

No

Genders Eligible for Study

Female

Sampling Method

Non-Probability Sample

Study Population

Pregnant women diagnosed with GDM, through Imperial College London Diabetes Centre (ICLDC) gestational diabetes clinic.

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

Cohorts and Interventions

Group / Cohort
Intervention / Treatment
GDM Current

Currently pregnant women diagnosed with GDM.

Next generation sequencing (NGS) methodologies will used on individuals suspected of genetic diabetes.
Genetic: Next generation sequencing (NGS)
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.
Genetic: Next generation sequencing (NGS)
NGS Panel, Whole exome/genome sequencing

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
GDM Identification
Time Frame: 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.
through study completion, an average of 2 year

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Next Generation Sequencing (NGS)
Time Frame: 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.
through study completion, an average of 2 year
Novel diabetes genes
Time Frame: through study completion, an average of 2 year
Identifying novel diabetes genes in the Emirati women with GDM by performing whole exome sequencing.
through study completion, an average of 2 year
Genetic test results validation
Time Frame: 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.
through study completion, an average of 2 year
Potential biomarkers
Time Frame: 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.
through study completion, an average of 2 year
Prevalence of MODY
Time Frame: through study completion, an average of 2 year
Determining the prevalence of MODY in women with GDM in the UAE.
through study completion, an average of 2 year
Clinical outcomes determination
Time Frame: 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
through study completion, an average of 2 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Imperial College London Diabetes Centre

Investigators

  • Principal Investigator: Torben Hansen, MD PhD, University of Copenhagen

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

January 1, 2017

Primary Completion (ANTICIPATED)

December 31, 2020

Study Completion (ANTICIPATED)

December 31, 2020

Study Registration Dates

First Submitted

July 2, 2018

First Submitted That Met QC Criteria

July 16, 2018

First Posted (ACTUAL)

July 17, 2018

Study Record Updates

Last Update Posted (ACTUAL)

June 25, 2020

Last Update Submitted That Met QC Criteria

June 24, 2020

Last Verified

June 1, 2020

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • IREC032

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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