Obesity & OverweightsEV-T2DNCT07728591
Blood-based sEV Proteins for Early Detection of 2 Diabetes
An observational study of Obesity & Overweight and Prediabetes / Type 2 Diabetes, run by Hong Kong Baptist University at 2 sites in 2 countries.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 59 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity & Overweight, Prediabetes / Type 2 Diabetes
- How many people
- 120 participants
- Where
- 2 sitesin 2 countries
- Study dates
- Oct 2026to Dec 2028
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 59 years
- All sexes
- Healthy volunteers accepted
- Adult
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.
Who may be able to join
- 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.
Who cannot join
- Cardiovascular disease.
- Cancer.
- History of surgery, as specified in the study protocol.
- Infectious disease.
- Osteoarthritis.
- Genetic disease.
- Pregnancy or breastfeeding.
- Suspected pregnancy.
Trial locations and contacts
2 sites in 2 countries. Contact the study team or a site near you to ask about taking part.
2 sites in 2 countries
China1 site
The Affiliated Traditional Chinese Medicine Hospital, Southwest Medical University
Luzhou, Sichuan
Mengyun Peng, +86 15228261073, pengmengyun@hkbu.edu.hk
Hong Kong1 site
Hong Kong Baptist University Mr. & Mrs. Chan Hon Yin Chinese Medicine Specialty Clinic and Good Clinical Practice Centre
Kowloon Tong
Kam Wa Chan, +852 34112962, chriskwc@hkbu.edu.hk
About this study
Official title: Identification of Blood-based sEV Proteins for Early Detection of At-risk Obese Individuals for Type 2 Diabetes
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.
- Keywords
- Small Extracellular Vesicles, Blood-Based Biomarkers, obesity&overweight, prediabetes/type 2 diabetes
- Medical subject headings
- Obesity, Overweight, Prediabetic State, Diabetes Mellitus, Type 2
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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. |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: At enrollment (single fasting blood collection)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Jul 2026
- Study startOct 2026 (estimated)
- Primary completionSep 2028 (estimated)
- Study completionDec 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Obesity & OverweightStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hong Kong Baptist University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Hiu Yee Kwan, Principal investigator, Hong Kong Baptist University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07728591
- Sponsor's protocol ID
- REC/25-26/0069
- Acronym
- sEV-T2D
- Status last verified
- Jul 2026
- First submitted
- 22 Jul 2026
- Last updated
- 30 Jul 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 30 Jul 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Identification of Blood-based sEV Proteins for Early Detection of At-risk Obese Individuals for Type 2 Diabetes
- ClinicalTrials.gov ID
- NCT07728591
- Acronym / sponsor ID
- sEV-T2D / REC/25-26/0069
- Keywords
- Small Extracellular Vesicles, Blood-Based Biomarkers, obesity&overweight, prediabetes/type 2 diabetes
- Study type
- Observational
- Recruitment status
- Not yet recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Hong Kong Baptist UniversityUniversity, hospital or other
- Study start
- Oct 2026 (estimated)
- Primary completion
- Sep 2028 (estimated)
- Study completion
- Dec 2028 (estimated)
- First posted
- 27 Jul 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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.
Study design
- Observational model
- Case-control
- Time perspective
- Cross-sectional
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| 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. |
Who may qualify
- Ages
- 40 to 59 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
- 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.
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (8 listed)
- Cardiovascular disease.
- Cancer.
- History of surgery, as specified in the study protocol.
- Infectious disease.
- Osteoarthritis.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Integrin-β2, ECM1 (and the protein candidates in our contingency plan) in circulating sEVs
Time frame: At enrollment (single fasting blood collection)
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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jul 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Hiu Yee Kwan principal investigator
Hong Kong Baptist University
2 sites in 2 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity & Overweight and Prediabetes / Type 2 Diabetes, run by Hong Kong Baptist University at 2 sites in 2 countries.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 30 Jul 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in China, Hong Kong. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Professor (+852 34112016, hykwan@hkbu.edu.hk), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the 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)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jul 2026.