NCT03589092

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

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
600

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Jan 2017

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

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

Completed
1.5 years until next milestone

First Submitted

Initial submission to the registry

July 2, 2018

Completed
15 days until next milestone

First Posted

Study publicly available on registry

July 17, 2018

Completed
2.5 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2020

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2020

Completed
Last Updated

June 25, 2020

Status Verified

June 1, 2020

Enrollment Period

4 years

First QC Date

July 2, 2018

Last Update Submit

June 24, 2020

Conditions

Keywords

GDMMODYGenetic testingNext Generation SequencingNGS

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.

Genetic: Next generation sequencing (NGS)

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)

Interventions

NGS Panel, Whole exome/genome sequencing

GDM CurrentGDM History

Eligibility Criteria

Age18 Years - 50 Years
Sexfemale
Healthy VolunteersNo
Age GroupsAdult (18-64)
Sampling MethodNon-Probability Sample
Study Population

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

RECRUITING

Biospecimen

Retention: SAMPLES WITH DNA

DNA will be extracted from collected blood samples for genetic analysis

MeSH Terms

Conditions

Diabetes, GestationalMason-Type DiabetesDiabetes Mellitus, Type 2

Interventions

High-Throughput Nucleotide Sequencing

Condition Hierarchy (Ancestors)

Pregnancy ComplicationsFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

Sequence AnalysisGenetic TechniquesInvestigative Techniques

Study Officials

  • Maha Barakat, PhD FRCP

    Imperial College London Diabetes Centre

    PRINCIPAL INVESTIGATOR
  • Torben Hansen, MD PhD

    University of Copenhagen

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Hinda Daggag, PhD

CONTACT

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

Locations