Clinical trial NCT03589092: Genetic Causes of Gestational Diabetes in the Emirati Population
Official title: Genetic Causes of Gestational Diabetes in the Emirati Population
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Gestational Diabetes
GDM
Maturity-onset Diabetes of the Young
MODY
Keywords: GDM
MODY
Genetic testing
Next Generation Sequencing
NGS
Lead sponsor: Imperial College London Diabetes Centre
Sponsor class: OTHER
First posted: 2018-07-17
Enrollment: 600
Sex: FEMALE
Minimum age (years): 18
Maximum age (years): 50
Standard ages: ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Pregnant women diagnosed with GDM, through Imperial College London Diabetes Centre (ICLDC) gestational diabetes clinic.

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.

Eligibility criteria: 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

Primary outcomes:
measure: GDM Identification
timeFrame: through study completion, an average of 2 year
Secondary outcomes:
measure: Next Generation Sequencing (NGS)
timeFrame: through study completion, an average of 2 year
measure: Novel diabetes genes
timeFrame: through study completion, an average of 2 year
measure: Genetic test results validation
timeFrame: through study completion, an average of 2 year
measure: Potential biomarkers
timeFrame: through study completion, an average of 2 year
measure: Prevalence of MODY
timeFrame: through study completion, an average of 2 year
measure: Clinical outcomes determination
timeFrame: through study completion, an average of 2 year
Other outcomes:
Locations:
city: Abu Dhabi
country: United Arab Emirates
facility: Imperial College London Diabetes Centre
Study officials:
affiliation: Imperial College London Diabetes Centre
name: Maha Barakat, PhD FRCP
role: PRINCIPAL_INVESTIGATOR
affiliation: University of Copenhagen
name: Torben Hansen, MD PhD
role: PRINCIPAL_INVESTIGATOR
References: