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Status:

UNKNOWN

Precision Medicine in Chinese Patients With Young Onset Diabetes

Lead Sponsor:

Chinese University of Hong Kong

Conditions:

Type 2 Diabetes

Eligibility:

All Genders

18-50 years

Phase:

NA

Brief Summary

Patients with young onset diabetes (YOD) are one of the most challenging groups of patients due to their long disease duration, complex causes, delayed interventions, psychosocial stress, poor adheren...

Detailed Description

Patients with young onset diabetes (YOD) are one of the most challenging groups of patients due to their long disease duration, complex causes, delayed interventions, psychosocial stress, poor adheren...

Eligibility Criteria

Inclusion

  • Part 1: Prospective cohort of Chinese with type 2 diabetes
  • Between 1995 and December 2004, 10,129 patients were assessed using structured protocol to esetablish the HKDR and of them, we have measured GADA and CP in 1400 patients with YOD. In this study, we shall measure CP and GADA in 4000 subjects from the HKDR with available GWAS data irrespective of their age of diagnosis. These samples were linked to our various databases by a unique identification code which will enable us to track the clinical outcomes including development of complications.
  • Part 2: Family-based cohort of first-degree relatives of diabetic probands
  • We shall utilize the resource of the HKDFS and control subjects to discover novel genetic variants of YOD. Subjects will be selected based on their status with or without diabetes. In 2012-2013, we ascertained the glycemic status of 365 siblings in the HKDFS and 452 participants of the community-based LKS cohort (aged 18-55 years) without diabetes at baseline (1998-2002).
  • In this cohort, 167 participants (53.7%) with a family history of YOD, 68 participants (30.1%) with a family history of late onset diabetes and 40 (14.4%) participants without family history of diabetes developed diabetes. Amongst the 313 siblings with family history of YOD, 167 had diabetes at baseline or developed diabetes during follow up and 146 did not develop diabetes after 13 years giving 100-120 sibpairs for linkage analysis. These sequence data will be imputed with 500 YOD patients and 500 control subjects with exome data as well as 6000 patients in the HKDR with GWAS data for analysis for validation purpose.
  • Part 3: RCT (PRISM)
  • Non-type 1 diabetes (T1D)
  • Chinese ethnicity
  • Age between 18-50 years inclusive
  • Age at diabetes diagnosis 40 years
  • Able to understand study requirements and voluntarily agree to participate by providing written informed consent

Exclusion

  • Part 1/2:
  • Subjects in the HKDR, HKFDS and LKS cohorts without or insuffiicent amount of biosamples for assays or sequencing.
  • Part 3:
  • T1D, defined by presentation with diabetic ketoacidosis or insulin requirement within 6 months of diagnosis.
  • Reduced life expectancy due to terminal illness or otherwise deemed not appropriate per discretion of the investigator

Key Trial Info

Start Date :

January 14 2020

Trial Type :

INTERVENTIONAL

Allocation :

ACTUAL

End Date :

December 31 2024

Estimated Enrollment :

884 Patients enrolled

Trial Details

Trial ID

NCT04049149

Start Date

January 14 2020

End Date

December 31 2024

Last Update

July 20 2022

Active Locations (1)

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1

The Chinese University of Hong Kong

Shatin, Hong Kong