Gestational DiabetesNCT03589092
Genetic Causes of Gestational Diabetes in the Emirati Population
An observational study of Gestational Diabetes and GDM, run by Imperial College London Diabetes Centre at 1 site in United Arab Emirates.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 50 years, women only
- Conditions the study is for
- Gestational Diabetes, GDM, Maturity-onset Diabetes of the Young
- What is being tested?
- Next generation sequencing (NGS)
- How many people
- 600 participants
- Where
- 1 siteUnited Arab Emirates
- Study dates
- 1 Jan 2017to 31 Dec 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 50 years
- Women only
- No healthy volunteers
- Adult
Study population: Pregnant women diagnosed with GDM, through Imperial College London Diabetes Centre (ICLDC) gestational diabetes clinic.
Who may be able to join
- Currently pregnant women diagnosed with GDM.
- Women with history of GDM (with negative GAD/IA2 antibodies if results available).
Who cannot join
- Women with positive GAD/IA2 antibodies (if results available)
- Women genetically diagnosed as MODY
Trial locations and contacts
1 site in 1 country.
United Arab Emirates1 site, 1 recruiting
- Recruiting
Imperial College London Diabetes Centre
Abu Dhabi, 48338
Hinda Daggag, PhD, +971 2 404 0800, hdaggag@icldc.ae
About this study
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.
Read the 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.
- Conditions
- Gestational Diabetes, GDM, Maturity-onset Diabetes of the Young, MODY
- Being tested
- Next generation sequencing (NGS)
- Keywords
- GDM, MODY, Genetic testing, Next Generation Sequencing, NGS
- Medical subject headings
- Diabetes, Gestational, Mason-Type Diabetes, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Next generation sequencing (NGS)Genetic
NGS Panel, Whole exome/genome sequencing
| Study group | Role | What they receive |
|---|---|---|
| GDM Current | Currently pregnant women diagnosed with GDM.
Next generation sequencing (NGS) methodologies will used on individuals suspected of genetic diabetes. Receives: 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. Receives: Genetic: Next generation sequencing (NGS) |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: through study completion, an average of 2 year
Secondary outcomes (6)
Next Generation Sequencing (NGS)
Next Generation Sequencing (NGS) technology will be applied to perform genetic testing, analysing 13 previously published MODY genes and potentially identifying novel causative mutations.
Measured: through study completion, an average of 2 year
Novel diabetes genes
Identifying novel diabetes genes in the Emirati women with GDM by performing whole exome sequencing.
Measured: through study completion, an average of 2 year
Genetic test results validation
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.
Measured: through study completion, an average of 2 year
Potential biomarkers
Identifying potential biomarkers in women with MODY and who are developing GDM, to assist the selection of women suitable for genetic screening.
Measured: through study completion, an average of 2 year
Prevalence of MODY
Determining the prevalence of MODY in women with GDM in the UAE.
Measured: through study completion, an average of 2 year
Clinical outcomes determination
Determining the short and the long-term clinical outcomes of MODY in women with GDM in the UAE
Measured: through study completion, an average of 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted17 Jul 2018
- Study start1 Jan 2017
- Primary completion31 Dec 2020 (estimated)
- Study completion31 Dec 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Gestational DiabetesStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 600 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Imperial College London Diabetes Centre
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Maha Barakat, PhD FRCP, Principal investigator, Imperial College London Diabetes CentreTorben Hansen, MD PhD, Principal investigator, University of Copenhagen
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT03589092
- Sponsor's protocol ID
- IREC032
- Status last verified
- Jun 2020
- First submitted
- 2 Jul 2018
- Last updated
- 25 Jun 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Jun 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Genetic Causes of Gestational Diabetes in the Emirati Population
- ClinicalTrials.gov ID
- NCT03589092
- Acronym / sponsor ID
- IREC032
- Conditions
- Gestational Diabetes, GDM, Maturity-onset Diabetes of the Young, MODY
- Keywords
- GDM, MODY, Genetic testing, Next Generation Sequencing, NGS
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 600 participants (estimated)
- Lead sponsor
- Imperial College London Diabetes CentreUniversity, hospital or other
- Study start
- 1 Jan 2017 (actual)
- Primary completion
- 31 Dec 2020 (estimated)
- Study completion
- 31 Dec 2020 (estimated)
- First posted
- 17 Jul 2018 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GDM Current | – | Genetic: Next generation sequencing (NGS)Currently pregnant women diagnosed with GDM. Next generation sequencing (NGS) methodologies will used on individuals suspected of genetic diabetes. |
| GDM History | – | Genetic: Next generation sequencing (NGS)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. |
Who may qualify
- Ages
- 18 to 50 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
- Study population
- Pregnant women diagnosed with GDM, through Imperial College London Diabetes Centre (ICLDC) gestational diabetes clinic.
Key inclusion criteria (2 listed)
- Currently pregnant women diagnosed with GDM.
- Women with history of GDM (with negative GAD/IA2 antibodies if results available).
Key exclusion criteria (2 listed)
- Women with positive GAD/IA2 antibodies (if results available)
- Women genetically diagnosed as MODY
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Next generation sequencing (NGS)NGS Panel, Whole exome/genome sequencing | Genetic | GDM Current, GDM History |
Primary outcome
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.
6 secondary outcomes
Next Generation Sequencing (NGS)
Time frame: through study completion, an average of 2 year
Novel diabetes genes
Time frame: through study completion, an average of 2 year
Genetic test results validation
Time frame: through study completion, an average of 2 year
Potential biomarkers
Time frame: through study completion, an average of 2 year
Prevalence of MODY
Time frame: through study completion, an average of 2 year
Clinical outcomes determination
Time frame: through study completion, an average of 2 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 Jun 2020.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Maha Barakat, PhD FRCP principal investigator
Imperial College London Diabetes Centre
Torben Hansen, MD PhD principal investigator
University of Copenhagen
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Gestational Diabetes and GDM, run by Imperial College London Diabetes Centre at 1 site in United Arab Emirates.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 25 Jun 2020. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United Arab Emirates. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Hinda Daggag, PhD (+971 2 404 0800, hdaggag@icldc.ae), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
GDM Identification (time frame: through study completion, an average of 2 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Jun 2020.