ClinicalTrials.gg
Not yet recruitingNCT07728591sEV-T2DUpdated Jul 30, 2026

Blood-based sEV Proteins for Early Detection of 2 Diabetes

An observational study in Obesity & Overweight and Prediabetes / Type 2 Diabetes, sponsored by Hong Kong Baptist University. Not yet recruiting at 2 sites in 2 countries. Open to participants aged 40 Years to 59 Years, including healthy volunteers. Per ClinicalTrials.gov, last updated 2026-07-30.

Sponsored by Hong Kong Baptist University · Observational

Study type
Observational
Model
Case-control
Time perspective
Cross-sectional
Enrollment
120
Ages
40 Years to 59 Years
Sex
All
01

Where this study stands

Counted across the records on this site · 2026-11-12

Among 597 studies in Obesity with a site in China — 220 open to participants now, 282 under way, 68 of them phase 3. Obesity · China.

Planned enrollment
77th of 98
120 · median 310
Started
2026
with 130 others
Observational
98 of 597
36 open now
Primary completion
2028-09
later than 245 of 280 live
Registered
529th of 597
by date

Among the 597 studies in Obesity with a site in China, this one is the 77th largest by planned enrollment of the 98 observational ones that give a count, is one of 131 that started in 2026, is one of 98 observational ones, reaches primary completion later than 245 of the 280 other live ones, and was the 529th registered.

Obesity

11,522 studies on the registry are indexed under Obesity; 2,033 are open to participants now.

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Open to participants now

220 of the 597 studies in Obesity with a site in China are open now. Recruiting first, the newest first:

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A study can be open while its sites in China have not opened yet or have stopped. Only those recruiting at a site in China →

Who these studies take

Of the 1,336 Obesity studies recruiting now, 377 (28%) set no upper age limit and 856 (64%) stop at 75 or younger; 168 take children under 18; 491 take healthy volunteers.

This study: 40 Years to 59 Years · all sexes · healthy volunteers too.

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02

Study 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.

Read the detailed description

Obesity is strongly associated with insulin resistance, prediabetes, and type 2 diabetes. Current screening approaches for prediabetes and type 2 diabetes mainly rely on glucose-related measurements, including fasting plasma glucose, OGTT, and HbA1c. These measurements are useful for identifying abnormal glucose regulation, but additional blood-based biomarkers may help identify obese individuals who are at higher risk of type 2 diabetes before or during the early stage of glucose dysregulation.

Small extracellular vesicles are circulating membrane-bound vesicles that carry proteins and other biomolecules. Previous work from the study team showed that integrin-β2 and extracellular matrix protein 1 were increased in circulating small extracellular vesicles from obese or overweight individuals. Given the well-known association between integrin/ECM and the development of insulin resistance, the study hypothesize 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 is an observational biomarker study in human participants. After informed consent, participants will undergo body mass index assessment and fasting blood collection after an overnight fast. Fasting plasma glucose and HbA1c will be measured by a registered clinical laboratory. BMI and glucose-related testing results, participants will be assigned to comparison groups including non-overweight/non-obese individuals, overweight/obese individuals, non-overweight/non-obese individuals with prediabetes or type 2 diabetes and overweight/obese individuals with prediabetes or type 2 diabetes.

Blood samples will be used for isolation of circulating small extracellular vesicles according to established laboratory protocols. The levels of integrin-β2, extracellular matrix protein 1, and other candidate small extracellular vesicle proteins will be measured. Protein levels will be compared across the study groups to determine whether these circulating small extracellular vesicle protein signatures are specifically associated with obesity-related prediabetes or type 2 diabetes.

The planned sample size for the human observational component is 120 participants, with 30 participants in each of the four groups. The sample size was calculated using G*Power to compare protein expression levels across four groups, assuming a medium effect size of 0.25, an alpha level of 0.05, and 80% statistical power. Participants will be assigned study codes. The code identifier file and study data will be stored separately in password-protected computers and will be accessible only to research personnel. Data will be deleted five years after study completion.

The main purpose of this study is to examine whether elevated integrin-β2 and /or ECM1 (and the protein candidates in contingency plan) in circulating sEVs is specific for obesity-associated 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.

03

Conditions studied

  • Obesity & Overweight
  • Prediabetes / Type 2 Diabetes

Keywords

  • Small Extracellular Vesicles
  • Blood-Based Biomarkers
  • obesity&overweight
  • prediabetes/type 2 diabetes
04

Who can participate

Ages eligible
40 Years to 59 Years
Sexes eligible
All
Accepts healthy volunteers
Yes
Sampling method
Non-probability sample

Study 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.

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Hong Kong citizens;
  • Male or female;
  • Aged 40-59 years;
  • Able and willing to provide written ;
  • Willing to undergo assessment and fasting blood collection after an overnight fast of at least 8 hours.

Exclusion criteria

Exclusion Criteria:

  • Cardiovascular disease.
  • Cancer.
  • History of surgery, as specified in the study protocol.
  • Infectious disease.
  • Osteoarthritis.
  • Genetic disease.
  • Pregnancy or breastfeeding.
  • Suspected pregnancy.
Terms in these criteria, in plain language(2)

Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.

Informed consent

Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.

You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.

BMI (body mass index)

Weight in kilograms divided by height in metres squared. Example: 70 kg and 1.75 m gives 70 ÷ (1.75 × 1.75) ≈ 22.9.

What counts as overweight or obesity differs between countries (some use lower cut-offs), so go by the range the study states.

05

Study design

Observational model
Case-control
Time perspective
Cross-sectional
Enrollment
120 participants (estimated)
Patient registry
No

Groups and cohorts

  • 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.

06

What researchers measure

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)

07

Study locations

2 sites
  • The Affiliated Traditional Chinese Medicine Hospital, Southwest Medical University
    Luzhou, Sichuan, China
  • Hong Kong Baptist University Mr. & Mrs. Chan Hon Yin Chinese Medicine Specialty Clinic and Good Clinical Practice Centre
    Kowloon Tong, Hong Kong
08

References and documents

Individual participant data

Plan to share: No

No publications or documents are linked to this record.

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Oct 2026; primary completion for Sep 2028, 23 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Jul 22, 2026
First posted
Jul 27, 2026
StartEst.
Oct 2026
Primary completionEst.
Sep 2028
CompletionEst.
Dec 2028
Last update
Jul 30, 2026
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Jul 30, 2026, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT07728591
Lead sponsor
Hong Kong Baptist University
Responsible party
Sponsor
First posted
Jul 27, 2026
Start date
Oct 2026 (estimated)
Primary completion
Sep 2028 (estimated)
Completion
Dec 2028 (estimated)
Last update
Jul 30, 2026

Study contacts

Professor
Contact
hykwan@hkbu.edu.hk
+852 34112016
Hiu Yee Kwan
principal investigator · Hong Kong Baptist University

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is not yet recruiting, as verified in Jul 2026. You cannot join it, but the record below documents what was studied.

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