Blood-based sEV Proteins for Early Detection of 2 Diabetes | NCT07728591

NCT07728591

Overview

NCT ID: NCT07728591
Lead Sponsor: Hong Kong Baptist UniversityOTHER
Official Title: Identification of Blood-based sEV Proteins for Early Detection of At-risk Obese Individuals for Type 2 Diabetes
Brief Summary: 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.

Status and Timeline

Status: Not yet recruiting
Last Update Posted: Jul 30, 2026Actual
Start Date: Oct 2026Estimated
Primary Completion Date: Sep 2028Estimated
Completion Date

Participation Criteria

Ages Eligible for Study: Adult (18-64)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: Yes
Eligibility Criteria: Inclusion Criteria:

Hong Kong citizens;

Male or female;

Aged 40-59 years;

Able and willing to provide written informed consent;

Willing to undergo BMI assessment and fasting blood collection after an overnight fast of at least 8 hours.

Exclusion Criteria:

Cardiovascular disease.

Cancer.

History of surgery, as specified in the study protocol.

Infectious disease.

Osteoarthritis.

Genetic disease.

Pregnancy or breastfeeding.

Suspected pregnancy.

Study Plan

Study Type: Observational
Phase: No data available
Enrollment: 120Estimated
Primary Purpose: No data available
Allocation: No data available
Interventional Model: No data available
Masking: No data available

Contacts and Locations

Central Contacts: ProfessorContact
hykwan@hkbu.edu.hk+852 34112016

Similar Studies

Participant Group/Arms

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.

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

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.

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.