Blood-based sEV Proteins for Early Detection of 2 Diabetes
Trial statusNot yet recruiting
Trial phaseNot listed
Trial typeObservational
Biological sexAll
Age40-59
SponsorHong Kong Baptist University
About this trial
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.
Eligibility criteria
This trial accepts healthy volunteersQualifiers
Hong Kong citizens;
Male or female;
Aged 40-59 years;
Able and willing to provide written informed consent;
Disqualifiers
Cardiovascular disease.
Cancer.
History of surgery, as specified in the study protocol.
Infectious disease.
Trial population
The study population will consist of Hong Kong residents aged 40 to 59 years recruited from the Hong Kong Baptist University Mr. \& Mrs. Chan Hon Yin Chinese Medicine Specialty Clinic and Good Clinical Practice Centre, as well as through recruitment posters and social media announcements. Participants will be classified into four groups according to BMI and glycemic status: non-overweight/non-obese participants without prediabetes or type 2 diabetes, overweight/obese participants without prediabetes or type 2 diabetes, non-overweight/non-obese participants with prediabetes or type 2 diabetes, and overweight/obese participants with prediabetes or type 2 diabetes. Approximately 30 participants will be enrolled in each group.
Trial design
Design model
Case-control
Time perspective
Cross-sectional
Treatments tested in this trial
Not listed
Trial groups
120 Participants
are grouped into 4 trial groupsGroup A: Normal Weight Without Prediabetes or T2D
Group B: Overweight or Obesity Without Prediabetes or T2D
Group C: Normal Weight With Prediabetes or T2D
Group D: Overweight or Obesity With Prediabetes or T2D
Trial outcomes
Primary outcomes
1
Integrin-β2, ECM1 (and the protein candidates in our contingency plan) in circulating sEVs
The protein level of integrin-β2, ECM1 (and the protein candidates in our contingency plan) in circulating sEVs will be measured. Protein levels will be compared among the four groups.
Time frame
At enrollment (single fasting blood collection)Sponsors and contacts
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Source ClinicalTrials.gov
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