Blood-based sEV Proteins for Early Detection of 2 Diabetes

Sponsor
Hong Kong Baptist University
Study ID
NCT07728591
Status
Not Yet Recruiting

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Conditions

  • Obesity & Overweight
  • Prediabetes / Type 2 Diabetes

Eligibility Criteria

Sex
ALL
Age
40 Years - 59 Years
Healthy Volunteers
Accepted

Study Details

The prevalence of diabetes in China is a significant concern. In 2019, 116.4 million adults were living with diabetes, a number expected to climb to 147.2 million by 2045. Type 2 diabetes (T2D) constitutes 95% of these cases . In Hong Kong, T2D affects an estimated 700,000 people, with prevalence keeps rising. Epidemiology data clearly show that obesity and T2D are closely associated. A previous study conducted by the investigators found that integrin-β2 protein levels are significantly increased in the circulating small extracellular vesicles (sEVs) of obese/overweight individuals. Given the well-known association between integrin/ECM and the development of insulin resistance, The study hypothesis is that integrin-β2 and ECM1 proteins in the circulating sEVs can be used for the early detection of obese individuals at risk for T2D.This proposed study is critical to provide supporting data for the implementation of a subsequent prospective cohort study to validate whether integrin β2/ECM1 proteins in circulating sEVs can be used for the early detection of obese individuals at risk for T2D.

Key Dates

First listed
Jul 27, 2026
Start date
Oct 31, 2026
Status verified
Jul 2026
Primary completion
Sep 30, 2028
Completion
Dec 31, 2028

Study Design

Enrollment
120 participants (estimated)

Arms

  • Arm: Normal Weight Without Prediabetes or T2D
    Participants with a BMI of 18.8 to 22.9 who do not meet the study criteria for prediabetes or type 2 diabetes.
  • Arm: Overweight or Obesity Without Prediabetes or T2D
    Participants who are overweight or obese, with a BMI of 23.0 or higher, and who do not meet the study criteria for prediabetes or type 2 diabetes
  • Arm: Normal Weight With Prediabetes or T2D
    Participants with a BMI of 18.8 to 22.9, who meet the study criteria for prediabetes or type 2 diabetes based on fasting plasma glucose and HbA1c measurements.
  • Arm: Overweight or Obesity With Prediabetes or T2D
    Participants who are overweight or obese, with a BMI of 23.0 or higher, and who meet the study criteria for prediabetes or type 2 diabetes based on fasting plasma glucose and HbA1c measurements.

Primary Outcome Measure

Integrin-β2, ECM1 (and the protein candidates in our contingency plan) in circulating sEVs [ Time Frame: At enrollment (single fasting blood collection) ]

Central Contacts

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