Precision Medicine in Chinese Patients With Young Onset Diabetes

Type 2 Diabetes Clinical Trial

Official title: Precision Medicine to Redefine Insulin Secretion and Monogenic Diabetes (PRISM) in Chinese Patients With Young Onset Diabetes

Status Active, not recruiting

Clinical Trial 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 adherence and frequent default. The investigator's previous studies indicate that provision of biogenetic information improved satisfaction, reduced ambiguity and improved self-efficacy in patients with T2D. Provision of personalized information using the web-based Joint Asia Diabetes Evaluation (JADE) Technology with risk stratification and decision support empowers better self care and medical intervention with improved control of risk factors. To further improve the precision of diagnosis for individualizing care, the use of CP, GADA, genetic risk scores (GRS) or rare genetic variants of maturity onset of diabetes (MODY) can help doctors select the most appropriate therapy in a timely manner. While patients with low CP, GADA and high GRS will benefit from early insulin therapy, some MODY variants are associated with good response to insulin-releasing oral drugs (e.g. sulphonylurea) which may spare the use of insulin with reduced patient distress and over-insulinization. By contrast, patients with high CP often due to obesity-associated insulin resistance should undergo intensive lifestyle modification and use of drugs with weight-reducing or neutral effects to avoid weight gain due to excessive dose of insulin.

Clinical Trial 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 adherence and frequent default. The investigator's previous studies indicate that provision of biogenetic information improved satisfaction, reduced ambiguity and improved self-efficacy in patients with T2D. Provision of personalized information using the web-based Joint Asia Diabetes Evaluation (JADE) Technology with risk stratification and decision support empowers better self care and medical intervention with improved control of risk factors. To further improve the precision of diagnosis for individualizing care, the use of CP, GADA, genetic risk scores (GRS) or rare genetic variants of maturity onset of diabetes (MODY) can help doctors select the most appropriate therapy in a timely manner. While patients with low CP, GADA and high GRS will benefit from early insulin therapy, some MODY variants are associated with good response to insulin-releasing oral drugs (e.g. sulphonylurea) which may spare the use of insulin with reduced patient distress and over-insulinization. By contrast, patients with high CP often due to obesity-associated insulin resistance should undergo intensive lifestyle modification and use of drugs with weight-reducing or neutral effects to avoid weight gain due to excessive dose of insulin.

PART 1:

Objective: To characterize Chinese patients diabetes classified by fasting CP and GADA positivity and their prognostic significance.

Methods: Fasting CP levels and GADA in stored biosamples of 4000 patients in the Hong Kong Diabetes Register (HKDR) followed up since 1995.

PART 2:

Objective: To uncover genetic variants/sequences associated with familial YOD. Methods: Whole genome sequencing (WGS) in stored DNA of 100-120 sibpairs of YOD after 13 years of follow-up for imputation with exome data of case-control cohort of YOD and genome wide association studies (GWAS) data of 200 YOD families and 6000 T2D patients.

PART 3:

Objectives: To examine the impacts of precision medicine augmented by information technology and biogenetic markers (JADEPRISM) on attainment of cardiometabolic targets at 1 year and clinical outcomes at 3 year (n=440), compared with JADE-augmented care (n=440) in YOD.

Deliverables A catalogue of biogenetic markers to guide precision medicine augmented by the JADE-Technology to optimize clinical outcomes in YOD. ;

Related Conditions & MeSH terms

• Diabetes Mellitus
• Diabetes Mellitus, Type 2
• Type 2 Diabetes

• NCT number: NCT04049149
• Study type: Interventional
• Source: Chinese University of Hong Kong
• Status: Active, not recruiting
• Phase: N/A
• Start date: January 14, 2020
• Completion date: December 31, 2024