Identifying Maturity-onset Diabetes of the Young in Emirati Patients

NCT05586594 | Not Yet Recruiting

• 1 other identifier: UAEU_CMHS_TWM_IM_MODY_2022
• Study Type: interventional
• Target: 150
• Locations: 0 countries
• Sites: N/A

Brief 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 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.

Conditions

Maturity-onset Diabetes of the Young; Monogenic Diabetes; MODY

Keywords

Maturity-onset Diabetes of the Young (MODY); Diabetes Mellitus; Diagnosis; Precision Medicine

Outcome Measures

Primary Outcomes (1)

• 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).

  24 months

Secondary Outcomes (3)

• To compare the value of MODY risk calculator and genetic testing outcome in Emirati patients

  24 months

• To see if C-peptide activity helps in differentiating monogenic diabetes from type 1

  24 months

• To find out the antibodies present in young patient with diabetes and if they are helpful in ruling out monogenic diabetes

  24 months

Study Arms (1)

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). • .

Diagnostic Test: Genetic testing for 4 MODY genes (GCK, HNF1A, HNF4A, HNF1B)

Interventions

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

patients labelled as Type 1 or Type 2 Diabetes

Eligibility Criteria

• Age: 12 Years - 45 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• United Arab Emirates University: lead

Related Publications (3)

• 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.

  PMID: 29473506 BACKGROUND

• Shields 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.

  PMID: 22218698 BACKGROUND

• Hattersley 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.

  PMID: 28314945 BACKGROUND

MeSH Terms

Conditions

Mason-Type Diabetes; Diabetes Mellitus, Type 2; Diabetes Mellitus; Disease

Interventions

Genetic Testing

Condition Hierarchy (Ancestors)

Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Clinical Laboratory Techniques; Diagnostic Techniques and Procedures; Diagnosis; Investigative Techniques; Genetic Techniques; Genetic Services; Health Services; Health Care Facilities Workforce and Services; Diagnostic Services; Preventive Health Services

Study Officials

• Adnan Agha

  United Arab Emirates University, College of Medicine & Health Sciences

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Adnan Agha

CONTACT

+971-3-7673333; adnanagha@uaeu.ac.ae

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: DIAGNOSTIC
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor, Internal Medicine, College of Medicine and Health Sciences, United Arab Emirates University

Study Record Dates

• First Submitted: October 14, 2022
• First Posted: October 19, 2022
• Study Start: March 1, 2024
• Primary Completion: December 1, 2025
• Study Completion (Estimated): June 1, 2026
• Last Updated: January 11, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share