Maturity-onset Diabetes of the YoungNCT05586594
Identifying Maturity-onset Diabetes of the Young in Emirati Patients
A study testing Genetic testing for 4 MODY genes (GCK, HNF1A, HNF4A, HNF1B) in people with Maturity-onset Diabetes of the Young and Monogenic Diabetes, run by United Arab Emirates University.
Trial summary
Diabetes Mellitus is a disease that affects nearly 1 in 5 people in United Arab Emirates and is one of leading causes of death and disability. The main reason for this condition is either relative or near complete deficiency of essential hormone made by our pancreas called "insulin", which is required to utilize blood… Read more about this study
- Who is it for?
- Ages 12 to 45 years
- Conditions the study is for
- Maturity-onset Diabetes of the Young, Monogenic Diabetes, MODY
- What is being tested?
- Genetic testing for 4 MODY genes (GCK, HNF1A, HNF4A, HNF1B)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- Mar 2024to Jun 2026
- Phase
- Interventional
- 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 12 to 45 years
- All sexes
- No healthy volunteers
- Child, Adult
Who may be able to join
- Age > 11; both male or female, Emirati patients only
- Diagnosed to have Type 1 or Type 2 Diabetes Mellitus diagnosed before the age of 40 and after the age of 6 months.
- Attended Tawam hospital during the last 1 year.
- All previous antibodies testing being negative.
- Absence of ketoacidosis / significant ketosis in the past medical records
Who cannot join
- BMI of 40 or above (class 3 / severe obesity)
- History of Secondary diabetes (e.g. Diabetes following pancreatitis)
- Absent/Decreased C-peptide activity suggestive of Type 1 Diabetes
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Identifying Maturity-onset Diabetes of the Young in Susceptible Emirati Patients Who Are Currently Treated as Type 1 or Type 2 Diabetes Mellitus
Diabetes Mellitus is a disease that affects nearly 1 in 5 people in United Arab Emirates and is one of leading causes of death and disability. The main reason for this condition is either relative or near complete deficiency of essential hormone made by our pancreas called "insulin", which is required to utilize blood sugar (glucose), and insulin shortage leads to increased blood glucose. The common types of this condition include type 2 Diabetes Mellitus (the most common with almost 90% of all diabetes patients having this condition), which is related to mismatch of body requirements and production of essential hormone called insulin (relative deficiency) and type 1 diabetes, in which body's own defense system causes of destruction of insulin producing cells in the pancreas (near complete deficiency of insulin). However, in younger age group (below the age of 35) there is another type of diabetes which affects nearly 1 out 1000 people and is Maturity onset diabetes of the young (MODY). MODY is a condition passed by parents in 50% of the kids due to an affected single gene and most common forms of MODY do not require any Insulin treatment. However as type 1 Diabetes is generally identified in younger age group, 80% of patient who have MODY cannot be diagnosed and are labelled with other forms of diabetes instead, and may receive unnecessary insulin injections. Although, there has been a lot of research done in the west on prevalence of MODY in white/Caucasian population, the studies in Middle East are minimal. Also, in the white/Caucasian population, a reliable risk calculator has been developed that predicts the risk of having MODY, which if found to be high, is then confirmed by genetic testing for MODY. There is no study available on presence of MODY or on the reliability of the MODY risk calculator among young Emirati population. There is also no data on MODY being misdiagnosed as other forms of diabetes in Emirati population.
This study proposal aims to address this gap of knowledge and assess the reliability of MODY calculator in young Emirati patients with diabetes and to see if any MODY patient exist in Diabetes clinics of Tawam hospital Abu Dhabi, who may have been misdiagnosed as type 1 or type 2.
Read the detailed description
Background:
Diabetes Mellitus (DM) affects more than half a billion people world-over, and there are nearly 72 million patients with diabetes in Middle East \& North Africa (MENA) region with United Arab Emirates having nearly a million of them.1 The most common type of DM is type 2 DM (nearly 90%) with impaired insulin secretion and usually associated with resistance to insulin actions, while others include gestational diabetes, DM secondary to pancreatic injury, immune mediated type 1 DM and monogenic diabetes. Monogenic diabetes encompasses previously termed maturity onset diabetes of the young as well as neonatal and mitochondrial disease all resulting from single gene defect. The prevalence of Monogenic Diabetes in European and North American population (mainly Caucasians) is 1/10,000 among adults, but for glucokinase (GCK) variant the prevalence can be as high as 1/1000. The prevalence of Monogenic Diabetes / MODY in Middle East population is not known with only two studies of more than 50 patients is Israel and Jordan mainly on GCK subtype. At present over 80% of Monogenic Diabetes patient are misdiagnosed and treated as either Type 1 or Type 2 diabetes mellitus. The commonest forms of treatment-requiring MODY are HNF4-alpha and HNF1-alpha, which do not necessarily require insulin, hence correct diagnosis can be life changing of these patients. There is MODY risk calculator developed by Exeter University that helps predict the presence of Monogenic diabetes but it is validated for Caucasian population only with no data on Emirati population. There are no studies at present on either assessing the presence of MODY in United Arab Emirates population or on identifying MODY patients who are already misdiagnosed with other forms of diabetes.
The aim of this study to assess the presence of common forms of Monogenic diabetes by genetic testing in susceptible adolescents/adults (based on MODY calculator risk factors \& antibody testing) who are already diagnosed with Diabetes Mellitus (either type 1 or Type 2)
Objective:
Primary:
To assess the frequency of MODY monogenic diabetes (commonest subtypes) among patients already labelled as Type 1 or Type 2 Diabetes (who have negative autoimmunity, lack of significant ketosis and either family history of diabetes in one parent or BMI<40).
Secondary:
- To assess the validity of MODY risk calculator for prediction of monogenic diabetes in Emirati patients
- To assess the validity of Insulin antibodies in ruling out monogenic diabetes
- To assess the validity of C-peptide activity level in differentiating type 1 diabetes from type 2 diabetes and monogenic diabetes
Data Collection:
The paediatric and adult diabetes clinics in Tawam Hospital Diabetes clinics and clinicians therein will be contacted and any patient meeting the above-mentioned selection criteria will be identified. An informed consent will take from patient and/or parent/guardian explaining the risks and benefits of the study. The patient without insulin antibody testing will undergo testing and only those patients who have negative antibodies will undergo C-peptide activity level (either non-stimulated serum C-peptide or 2-hour post prandial urinary C-peptide creatinine ratio) and only those with absent/reduced C-peptide levels will be excluded. Demographic details and clinical parameters like BMI, duration of diabetes, treatment history and co-morbidities will be obtained. The patient's routine diabetes related blood tests including (HbA1c, liver function tests, albumin, bilirubin, Prothrombin time, albumin, creatinine) done in the last 3months and demographic data (non-identifiable) will be initially gathered on a data collection sheet which will then be transferred to electronic data in Microsoft Excel sheet and stored on a secure server. The MODY risk score will be calculated using the published formula (available at website https://www.diabetesgenes.org/exeter-diabetes-app/ModyCalculator).
The patient will be seen as per routine clinical care and on the next set of blood work additional vials of blood sample will be taken for monogenic testing. No separate venesection or additional visit for the patient will be required. Copy of the monogenic testing will be provided to the clinician in-charge of the patient to help with any clinical decisions.
Confidentiality:
No patient specific identifiable data will be stored in this study. All other data stored will be on United Arab Emirates University secure server. The proposal will be sent to the Research and Ethics committee Tawam for approval as well as to UAEU human ethics committee.
Funding:
There will be funding required for this study for additional testing (including C-peptide activity/antibody testing and genetic testing) as well as for research assistant for 2 years.
Conflict of interest:
None
Financial disclosure:
None
- Being tested
- Genetic testing for 4 MODY genes (GCK, HNF1A, HNF4A, HNF1B)
- Keywords
- Maturity-onset Diabetes of the Young (MODY), Diabetes Mellitus, Diagnosis, Precision Medicine
- Medical subject headings
- Mason-Type Diabetes, Diabetes Mellitus, Type 2, Diabetes Mellitus, Disease
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Genetic testing for 4 MODY genes (GCK, HNF1A, HNF4A, HNF1B)Diagnostic test
Genetic testing for 4 MODY genes (GCK, HNF1A, HNF4A, HNF1B) to look for common non-syndromic MODY in Emirati population
| Study group | Role | What they receive |
|---|---|---|
| patients labelled as Type 1 or Type 2 Diabetes | Other | paediatric or adult patients already diagnosed with either type 1 or type 2 diabetes mellitus, following up with Tawam Hospital Diabetes clinics for at least 1 year, (who have negative autoimmunity, lack of significant ketosis and either family history of diabetes in one parent or BMI<40).
Patient with age > 11; both male or female, Emirati patients only, who attended Diabetes clinic Tawam hospital during the last 1 year AND Diagnosed to have Type 1 or Type 2 Diabetes Mellitus diagnosed before the age of 40 and after the age of 6 months (to exclude neonatal diabetes).
• . Receives: Diagnostic Test: Genetic testing for 4 MODY genes (GCK, HNF1A, HNF4A, HNF1B) |
What is being measured
The primary outcome is the main question the study is designed to answer.
To see how many patient with diabetes diagnosed at early age with features not suggestive of type 1 or type 2 are found to have MODY monogenic diabetes (commonest subtypes) among young Emirati patients
To assess the frequency of MODY monogenic diabetes (commonest subtypes) among patients already labelled as Type 1 or Type 2 Diabetes (who have negative autoimmunity, lack of significant ketosis and either family history of diabetes in one parent or BMI<40).
Measured: 24 months
Secondary outcomes (3)
To compare the value of MODY risk calculator and genetic testing outcome in Emirati patients
To assess the validity of MODY risk calculator for prediction of monogenic diabetes in Emirati patients
Measured: 24 months
To see if C-peptide activity helps in differentiating monogenic diabetes from type 1
To assess the validity of C-peptide activity level in differentiating type 1 diabetes from type 2 diabetes and monogenic diabetes
Measured: 24 months
To find out the antibodies present in young patient with diabetes and if they are helpful in ruling out monogenic diabetes
To assess the validity of Insulin antibodies (anti-GAD65, IAA2, Anti-Zn8) in ruling out monogenic diabetes
Measured: 24 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2022
- Study startMar 2024 (estimated)
- Primary completionDec 2025 (estimated)
- Study completionJun 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for Maturity-onset Diabetes of the YoungStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- United Arab Emirates University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr Adnan Agha, United Arab Emirates University
- Investigators
- Adnan Agha, Principal investigator, United Arab Emirates University, College of Medicine & Health Sciences
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05586594
- Sponsor's protocol ID
- UAEU_CMHS_TWM_IM_MODY_2022
- Status last verified
- Jan 2024
- First submitted
- 14 Oct 2022
- Last updated
- 11 Jan 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: At the end of the study datasheet with clinical and biochemical parameters including antibody, MODY risk calculation, C-peptide activity and genetic testing results (with no personal identifiable information) could be shared.
Publications
Taneera J, Mussa B, Saber-Ayad M, Dhaiban S, Aljaibeji H, Sulaiman N. Maturity-Onset Diabetes of the Young: An Overview with Focus on the Middle East. Curr Mol Med. 2017;17(8):549-562. doi: 10.2174/1566524018666180222121158.
PubMed 29473506Shields BM, McDonald TJ, Ellard S, Campbell MJ, Hyde C, Hattersley AT. The development and validation of a clinical prediction model to determine the probability of MODY in patients with young-onset diabetes. Diabetologia. 2012 May;55(5):1265-72. doi: 10.1007/s00125-011-2418-8. Epub 2012 Jan 5.
PubMed 22218698Hattersley AT, Patel KA. Precision diabetes: learning from monogenic diabetes. Diabetologia. 2017 May;60(5):769-777. doi: 10.1007/s00125-017-4226-2. Epub 2017 Mar 17.
PubMed 28314945
Study at a glance
From the registry record, last updated by the sponsor on 11 Jan 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identifying Maturity-onset Diabetes of the Young in Susceptible Emirati Patients Who Are Currently Treated as Type 1 or Type 2 Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT05586594
- Acronym / sponsor ID
- UAEU_CMHS_TWM_IM_MODY_2022
- Keywords
- Maturity-onset Diabetes of the Young (MODY), Diabetes Mellitus, Diagnosis, Precision Medicine
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- United Arab Emirates UniversityUniversity, hospital or other
- Study start
- Mar 2024 (estimated)
- Primary completion
- Dec 2025 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 19 Oct 2022 (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.
Diabetes Mellitus is a disease that affects nearly 1 in 5 people in United Arab Emirates and is one of leading causes of death and disability. The main reason for this condition is either relative or near complete deficiency of essential hormone made by our pancreas called "insulin", which is required to utilize blood sugar (glucose), and insulin shortage leads to increased blood glucose. The common types of this condition include type 2 Diabetes Mellitus (the most common with almost 90% of all diabetes patients having this condition), which is related to mismatch of body requirements and production of essential hormone called insulin (relative deficiency) and type 1 diabetes, in which body's own defense system causes of destruction of insulin producing cells in the pancreas (near complete deficiency of insulin). However, in younger age group (below the age of 35) there is another type of diabetes which affects nearly 1 out 1000 people and is Maturity onset diabetes of the young (MODY). MODY is a condition passed by parents in 50% of the kids due to an affected single gene and most common forms of MODY do not require any Insulin treatment. However as type 1 Diabetes is generally identified in younger age group, 80% of patient who have MODY cannot be diagnosed and are labelled with other forms of diabetes instead, and may receive unnecessary insulin injections. Although, there has been a lot of research done in the west on prevalence of MODY in white/Caucasian population, the studies in Middle East are minimal. Also, in the white/Caucasian population, a reliable risk calculator has been developed that predicts the risk of having MODY, which if found to be high, is then confirmed by genetic testing for MODY. There is no study available on presence of MODY or on the reliability of the MODY risk calculator among young Emirati population. There is also no data on MODY being misdiagnosed as other forms of diabetes in Emirati population.
This study proposal aims to address this gap of knowledge and assess the reliability of MODY calculator in young Emirati patients with diabetes and to see if any MODY patient exist in Diabetes clinics of Tawam hospital Abu Dhabi, who may have been misdiagnosed as type 1 or type 2.
Detailed description
Background:
Diabetes Mellitus (DM) affects more than half a billion people world-over, and there are nearly 72 million patients with diabetes in Middle East \& North Africa (MENA) region with United Arab Emirates having nearly a million of them.1 The most common type of DM is type 2 DM (nearly 90%) with impaired insulin secretion and usually associated with resistance to insulin actions, while others include gestational diabetes, DM secondary to pancreatic injury, immune mediated type 1 DM and monogenic diabetes. Monogenic diabetes encompasses previously termed maturity onset diabetes of the young as well as neonatal and mitochondrial disease all resulting from single gene defect. The prevalence of Monogenic Diabetes in European and North American population (mainly Caucasians) is 1/10,000 among adults, but for glucokinase (GCK) variant the prevalence can be as high as 1/1000. The prevalence of Monogenic Diabetes / MODY in Middle East population is not known with only two studies of more than 50 patients is Israel and Jordan mainly on GCK subtype. At present over 80% of Monogenic Diabetes patient are misdiagnosed and treated as either Type 1 or Type 2 diabetes mellitus. The commonest forms of treatment-requiring MODY are HNF4-alpha and HNF1-alpha, which do not necessarily require insulin, hence correct diagnosis can be life changing of these patients. There is MODY risk calculator developed by Exeter University that helps predict the presence of Monogenic diabetes but it is validated for Caucasian population only with no data on Emirati population. There are no studies at present on either assessing the presence of MODY in United Arab Emirates population or on identifying MODY patients who are already misdiagnosed with other forms of diabetes.
The aim of this study to assess the presence of common forms of Monogenic diabetes by genetic testing in susceptible adolescents/adults (based on MODY calculator risk factors \& antibody testing) who are already diagnosed with Diabetes Mellitus (either type 1 or Type 2)
Objective:
Primary:
To assess the frequency of MODY monogenic diabetes (commonest subtypes) among patients already labelled as Type 1 or Type 2 Diabetes (who have negative autoimmunity, lack of significant ketosis and either family history of diabetes in one parent or BMI<40).
Secondary:
- To assess the validity of MODY risk calculator for prediction of monogenic diabetes in Emirati patients
- To assess the validity of Insulin antibodies in ruling out monogenic diabetes
- To assess the validity of C-peptide activity level in differentiating type 1 diabetes from type 2 diabetes and monogenic diabetes
Data Collection:
The paediatric and adult diabetes clinics in Tawam Hospital Diabetes clinics and clinicians therein will be contacted and any patient meeting the above-mentioned selection criteria will be identified. An informed consent will take from patient and/or parent/guardian explaining the risks and benefits of the study. The patient without insulin antibody testing will undergo testing and only those patients who have negative antibodies will undergo C-peptide activity level (either non-stimulated serum C-peptide or 2-hour post prandial urinary C-peptide creatinine ratio) and only those with absent/reduced C-peptide levels will be excluded. Demographic details and clinical parameters like BMI, duration of diabetes, treatment history and co-morbidities will be obtained. The patient's routine diabetes related blood tests including (HbA1c, liver function tests, albumin, bilirubin, Prothrombin time, albumin, creatinine) done in the last 3months and demographic data (non-identifiable) will be initially gathered on a data collection sheet which will then be transferred to electronic data in Microsoft Excel sheet and stored on a secure server. The MODY risk score will be calculated using the published formula (available at website https://www.diabetesgenes.org/exeter-diabetes-app/ModyCalculator).
The patient will be seen as per routine clinical care and on the next set of blood work additional vials of blood sample will be taken for monogenic testing. No separate venesection or additional visit for the patient will be required. Copy of the monogenic testing will be provided to the clinician in-charge of the patient to help with any clinical decisions.
Confidentiality:
No patient specific identifiable data will be stored in this study. All other data stored will be on United Arab Emirates University secure server. The proposal will be sent to the Research and Ethics committee Tawam for approval as well as to UAEU human ethics committee.
Funding:
There will be funding required for this study for additional testing (including C-peptide activity/antibody testing and genetic testing) as well as for research assistant for 2 years.
Conflict of interest:
None
Financial disclosure:
None
Study design
- Primary purpose
- Diagnosis
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| patients labelled as Type 1 or Type 2 Diabetes | Other | Diagnostic Test: Genetic testing for 4 MODY genes (GCK, HNF1A, HNF4A, HNF1B)paediatric or adult patients already diagnosed with either type 1 or type 2 diabetes mellitus, following up with Tawam Hospital Diabetes clinics for at least 1 year, (who have negative autoimmunity, lack of significant ketosis and either family history of diabetes in one parent or BMI<40). Patient with age > 11; both male or female, Emirati patients only, who attended Diabetes clinic Tawam hospital during the last 1 year AND Diagnosed to have Type 1 or Type 2 Diabetes Mellitus diagnosed before the age of 40 and after the age of 6 months (to exclude neonatal diabetes). • . |
Who may qualify
- Ages
- 12 to 45 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult
Key inclusion criteria (5 listed)
- Age > 11; both male or female, Emirati patients only
- Diagnosed to have Type 1 or Type 2 Diabetes Mellitus diagnosed before the age of 40 and after the age of 6 months.
- Attended Tawam hospital during the last 1 year.
- All previous antibodies testing being negative.
- Absence of ketoacidosis / significant ketosis in the past medical records
Key exclusion criteria (3 listed)
- BMI of 40 or above (class 3 / severe obesity)
- History of Secondary diabetes (e.g. Diabetes following pancreatitis)
- Absent/Decreased C-peptide activity suggestive of Type 1 Diabetes
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 |
|---|---|---|
| Genetic testing for 4 MODY genes (GCK, HNF1A, HNF4A, HNF1B)Genetic testing for 4 MODY genes (GCK, HNF1A, HNF4A, HNF1B) to look for common non-syndromic MODY in Emirati population | Diagnostic test | patients labelled as Type 1 or Type 2 Diabetes |
Primary outcome
To see how many patient with diabetes diagnosed at early age with features not suggestive of type 1 or type 2 are found to have MODY monogenic diabetes (commonest subtypes) among young Emirati patients
Time frame: 24 months
To assess the frequency of MODY monogenic diabetes (commonest subtypes) among patients already labelled as Type 1 or Type 2 Diabetes (who have negative autoimmunity, lack of significant ketosis and either family history of diabetes in one parent or BMI<40).
3 secondary outcomes
To compare the value of MODY risk calculator and genetic testing outcome in Emirati patients
Time frame: 24 months
To see if C-peptide activity helps in differentiating monogenic diabetes from type 1
Time frame: 24 months
To find out the antibodies present in young patient with diabetes and if they are helpful in ruling out monogenic diabetes
Time frame: 24 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Jan 2024.
- Background: PubMed 29473506Taneera J, Mussa B, Saber-Ayad M, Dhaiban S, Aljaibeji H, Sulaiman N. Maturity-Onset Diabetes of the Young: An Overview with Focus on the Middle East. Curr Mol Med. 2017;17(8):549-562. doi: 10.2174/1566524018666180222121158.
- Background: PubMed 22218698Shields BM, McDonald TJ, Ellard S, Campbell MJ, Hyde C, Hattersley AT. The development and validation of a clinical prediction model to determine the probability of MODY in patients with young-onset diabetes. Diabetologia. 2012 May;55(5):1265-72. doi: 10.1007/s00125-011-2418-8. Epub 2012 Jan 5.
- Background: PubMed 28314945Hattersley AT, Patel KA. Precision diabetes: learning from monogenic diabetes. Diabetologia. 2017 May;60(5):769-777. doi: 10.1007/s00125-017-4226-2. Epub 2017 Mar 17.
- Individual participant dataSharing planned: No. At the end of the study datasheet with clinical and biochemical parameters including antibody, MODY risk calculation, C-peptide activity and genetic testing results (with no personal identifiable information) could be shared.
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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.
Adnan Agha principal investigator
United Arab Emirates University, College of Medicine & Health Sciences
Questions about this trial
What is this clinical trial studying?
A study testing Genetic testing for 4 MODY genes (GCK, HNF1A, HNF4A, HNF1B) in people with Maturity-onset Diabetes of the Young and Monogenic Diabetes, run by United Arab Emirates University.
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 5 inclusion and 3 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 11 Jan 2024. Status can change between updates, so confirm with the study contact before making plans.
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 Adnan Agha (+971-3-7673333 ext. 7677, adnanagha@uaeu.ac.ae), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To see how many patient with diabetes diagnosed at early age with features not suggestive of type 1 or type 2 are found to have MODY monogenic diabetes (commonest subtypes) among young Emirati patients (time frame: 24 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT05586594, which also lists 3 linked publications.
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 11 Jan 2024.