Genetic Causes of Gestational Diabetes in the Emirati Population
1 other identifier
observational
600
1 country
1
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.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Jan 2017
Longer than P75 for all trials
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
Study Start
First participant enrolled
January 1, 2017
CompletedFirst Submitted
Initial submission to the registry
July 2, 2018
CompletedFirst Posted
Study publicly available on registry
July 17, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 31, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
December 31, 2020
CompletedJune 25, 2020
June 1, 2020
4 years
July 2, 2018
June 24, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
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 Outcomes (6)
Next Generation Sequencing (NGS)
through study completion, an average of 2 year
Novel diabetes genes
through study completion, an average of 2 year
Genetic test results validation
through study completion, an average of 2 year
Potential biomarkers
through study completion, an average of 2 year
Prevalence of MODY
through study completion, an average of 2 year
- +1 more secondary outcomes
Study Arms (2)
GDM Current
Currently pregnant women diagnosed with GDM. Next generation sequencing (NGS) methodologies will used on individuals suspected of genetic diabetes.
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.
Interventions
NGS Panel, Whole exome/genome sequencing
Eligibility Criteria
Pregnant women diagnosed with GDM, through Imperial College London Diabetes Centre (ICLDC) gestational diabetes clinic.
You may qualify if:
- Currently pregnant women diagnosed with GDM.
- Women with history of GDM (with negative GAD/IA2 antibodies if results available).
You may not qualify if:
- Women with positive GAD/IA2 antibodies (if results available)
- Women genetically diagnosed as MODY
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Imperial College London Diabetes Centre
Abu Dhabi, 48338, United Arab Emirates
Biospecimen
DNA will be extracted from collected blood samples for genetic analysis
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Maha Barakat, PhD FRCP
Imperial College London Diabetes Centre
- PRINCIPAL INVESTIGATOR
Torben Hansen, MD PhD
University of Copenhagen
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- CROSS SECTIONAL
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
July 2, 2018
First Posted
July 17, 2018
Study Start
January 1, 2017
Primary Completion
December 31, 2020
Study Completion
December 31, 2020
Last Updated
June 25, 2020
Record last verified: 2020-06