NCT03607604

Brief Summary

The study aims to investigate the validity of 2 hour post-prandial UCPCR test in paediatric and adult patients with diabetes duration greater than 2 and 5 years, respectively, for the purposes of distinguishing between patients with type 1 diabetes and MODY in the UAE population.

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
778

participants targeted

Target at P75+ for all trials

Timeline
Completed

Started Apr 2015

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

April 1, 2015

Completed
3.2 years until next milestone

First Submitted

Initial submission to the registry

June 26, 2018

Completed
1 month until next milestone

First Posted

Study publicly available on registry

July 31, 2018

Completed
3.4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

December 31, 2021

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

December 31, 2021

Completed
Last Updated

August 19, 2020

Status Verified

August 1, 2020

Enrollment Period

6.8 years

First QC Date

June 26, 2018

Last Update Submit

August 18, 2020

Conditions

Diabetes Mellitus, Type 1Diabetes Mellitus, Type 2Maturity-onset Diabetes of the Young

Keywords

MODYDiabetes MellitusUCPCRMonogenic Diabetes

Outcome Measures

Primary Outcomes (1)

  • Urinary C-peptide Creatinine Ratio (UCPCR)

    Measuring UCPCR in our study cohort and testing if a cutoff of 0.7nmol/mmol in children and 0.2nmol/mmol in adults will apply to our population of interest (ie UAE population).

    2 hours post-prandial

Secondary Outcomes (6)

  • Receiver operating characteristic (ROC) curve

    through study completion, an average of 1 year

  • Genetic analysis

    through study completion, an average of 2 year

  • Positive genetic result analysis

    through study completion, an average of 2 year

  • Novel MODY genes and mutations

    through study completion, an average of 2 year

  • UCPCR measurements

    through study completion, an average of 2 year

  • +1 more secondary outcomes

Study Arms (3)

Autoantibody Negative

Patients who are autoantibody negative (could potentially be either MODY or type 2 diabetes patients) Suspected MODY patients will be candidates for next generation sequencing (NGS)

Genetic: Next generation sequencing (NGS)

Diabetes Mellitus, Type 1

Patients diagnosed with type 1 diabetes mellitus Patients with positive UCPCR and negative autoantibodies results will be suspected with MODY and will be candidates for next generation sequencing (NGS)

Genetic: Next generation sequencing (NGS)

Non Diabetic

Individuals not diagnosed with any type of diabetes (but could be diagnosed with IFG and/or IGT)

Interventions

Next generation sequencing (NGS)GENETIC

Patients will be tested for known MODY genes with specific focus on HNF1A, GCK and HNF4A genes. Furthermore, gene panel testing may be performed for any known diabetes genes.If the results are negative, WES/WGS will be performed in patients suspected of having MODY for identification of novel MODY mutations.

Also known as: NGS panel, Whole exome/genome sequencing (WES/WGS)
Autoantibody NegativeDiabetes Mellitus, Type 1

Eligibility Criteria

Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-Probability Sample
Study Population

Patients attending Imperial College London Diabetes Centre, UAE.

You may qualify if:

  • patients with age and age of diabetes onset of \<18 years
  • patients with age of ≥18 years and age of diabetes onset of ≤30 years

You may not qualify if:

  • \- patients with age of ≥18 years and age of diabetes onset of \>30 years

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Imperial College London Diabetes Centre

Abu Dhabi, 48338, United Arab Emirates

Location

Biospecimen

Retention: SAMPLES WITH DNA

DNA will be extracted from collected blood samples for genetic analysis (suspected MODY cases)

MeSH Terms

Conditions

Diabetes Mellitus, Type 1Diabetes Mellitus, Type 2Mason-Type DiabetesDiabetes Mellitus

Interventions

High-Throughput Nucleotide Sequencing

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System DiseasesAutoimmune DiseasesImmune System Diseases

Intervention Hierarchy (Ancestors)

Sequence AnalysisGenetic TechniquesInvestigative Techniques

Study Officials

  • Nader Lessan, MBBS FRCP MD

    Imperial College London Diabetes Centre

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
CROSS SECTIONAL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 26, 2018

First Posted

July 31, 2018

Study Start

April 1, 2015

Primary Completion

December 31, 2021

Study Completion

December 31, 2021

Last Updated

August 19, 2020

Record last verified: 2020-08

Locations

AE(1)