Type 2 Diabetes Mellitus (T2DM)Phase 2Col-DMNCT07837934
Colchicine for Primary Prevention of Cardiovascular Disease in Adults With Type 2 Diabetes
A Phase 2 study testing Colchicine 0.5 MG Oral Tablet Once Daily in people with Type 2 Diabetes Mellitus (T2DM) and Atherosclerosis, run by Tan Tock Seng Hospital at 1 site in Singapore.
Trial summary
This study will test whether a low-cost anti-inflammatory medicine called colchicine can help protect the blood vessels of people with type 2 diabetes. Diabetes speeds up hardening of the arteries (atherosclerosis), partly because of ongoing low-grade inflammation. Read more about this study
- Who is it for?
- Ages 21 to 80 years
- Conditions the study is for
- Type 2 Diabetes Mellitus (T2DM), Atherosclerosis, Cardiovascular Diseases
- What is being tested?
- Colchicine 0.5 MG Oral Tablet Once Daily
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 300 participants
- Where
- 1 siteSingapore
- Study dates
- 24 Jul 2025to 31 Jul 2027
- Phase
- Phase 2
- 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 21 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- T2DM on stable diabetes medications (no change in last 3 months)
- At least one other comorbidity of hypertension, dyslipidaemia and/or obesity (BMI ≥27), with no previous history of ASCVD
- Able to provide informed consent
Who cannot join
- Recent hospitalization or acute infections within last 2 weeks.
- Current Treatment with corticosteroids or immunosuppressive agents
- Pre-existing malignancies or other terminal conditions with limited prognosis
- Pregnancy
- Breastfeeding
- Inability to provide written consent
Show all 17Show fewer
- Renal impairment (eGFR< 60ml/min)
- Liver cirrhosis or ALT/AST >3x ULN
- Pharmacogenomics indicative of adverse effects
- Hypersensitivity to the active substance or to the following excipients: Lactose, Maize starch, Sodium laurilsulfate, Magnesium stearate
- Known blood dyscrasia
- Women of childbearing age who are keen to conceive in the next 1 year
- Taking a strong P-glycoprotein inhibitor (e.g. cyclosporine, ranolazine) or a strong CYP3A4 inhibitor
- Known myositis with raised creatine kinase with statins (statin myopathy).
- Gout attack within the last 1 year
- Currently taking Aspirin
- Taking any oral contraceptives
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Shirley Lin Shangmei contact
Singapore1 site, 1 recruiting
- Recruiting
Tan Tock Seng Hospital
Singapore, Singapore, 308433
Rinkoo Dalan, MD, PhD, 65-6357100, rinkoo.dalan@nhghealth.com.sg
Rinkoo Dalan, MD, PhD
About this study
Official title: The Role of Colchicine in Preventing Atherosclerotic Cardiovascular Disease in Type 2 Diabetes (Col-DM Study)
This study will test whether a low-cost anti-inflammatory medicine called colchicine can help protect the blood vessels of people with type 2 diabetes. Diabetes speeds up hardening of the arteries (atherosclerosis), partly because of ongoing low-grade inflammation. Colchicine has already been shown to help prevent heart attacks and strokes in people who already have heart disease; this study looks at whether it can also help prevent early blood vessel damage before heart disease develops. Around 300 adults with type 2 diabetes will be randomly assigned to take colchicine or a placebo (dummy pill) once daily for 24 weeks, in addition to their usual diabetes and heart-risk medications. Neither participants nor the study team will know who is taking colchicine or placebo. The main measurement will be the change in the thickness of the wall of the neck (carotid) artery, measured by ultrasound, which is an early sign of blood vessel disease. The study will also look at markers of inflammation in the blood, blood vessel stiffness and function, and changes in the gut bacteria.
Read the detailed description
Cardiovascular disease remains the leading cause of death in T2DM, occurring earlier and at substantially higher rates than in the general population. Despite optimisation of conventional risk factors, residual cardiovascular risk remains high, with chronic low-grade inflammation driven by dysregulated neutrophil activity recognised as a key contributor. Patients with T2DM exhibit a distinct pro-inflammatory neutrophil phenotype characterised by increased neutrophil extracellular trap (NET) formation, heightened endothelial adherence, and altered rolling kinetics, which correlates with impaired vascular function and subclinical atherosclerosis.
Colchicine inhibits neutrophil activation, migration, and NET formation, and has demonstrated efficacy in secondary cardiovascular prevention in large randomised trials. Evidence in primary prevention, particularly in T2DM, remains limited. Col-DM takes a precision medicine approach, hypothesising that colchicine's benefit will be concentrated among T2DM patients with a high-risk inflamed neutrophil signature rather than being uniform across the broader population.
Col-DM is a 24-week, parallel-group, Phase 2 randomised controlled trial. Adults with T2DM and no prior atherosclerotic cardiovascular disease are randomised 1:1 to colchicine 0.5 mg daily or matched placebo, stratified by neutrophil inflammatory phenotype classified using a microfluidic organ-on-chip platform. The primary outcome is progression of carotid intima-media thickness (CIMT), estimated overall and separately within each neutrophil-signature stratum. Secondary outcomes cover vascular function, inflammatory and oxidative stress biomarkers, and thrombotic potential. Gut microbiome composition is examined as an exploratory outcome. All outcome measures are estimated overall and separately within each neutrophil-signature stratum. Safety is monitored by an independent Data and Safety Monitoring Committee.
- Being tested
- Colchicine 0.5 MG Oral Tablet Once Daily, Placebo
- Keywords
- Colchicine, Inflammation, Neutrophils, Carotid Intima-Media Thickness, Primary Prevention
- Medical subject headings
- Diabetes Mellitus, Type 2, Atherosclerosis, Cardiovascular Diseases, Inflammation
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Colchicine 0.5 MG Oral Tablet Once DailyDrug
For 24 weeks
PlaceboDrug
Matched placebo tablets (identical in size, shape, taste, and packaging to colchicine), once daily, for 24 weeks
| Study group | Role | What they receive |
|---|---|---|
| Colchicine | Experimental | Colchicine 0.5 mg orally once daily for 24 weeks, in addition to usual risk-factor-based therapy Receives: Drug: Colchicine 0.5 MG Oral Tablet Once Daily |
| Placebo | Placebo comparator | Matched placebo orally once daily for 24 weeks, in addition to usual risk-factor-based therapy Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from Baseline in Mean-Maximum Carotid Intima-Media Thickness (Mean-Maximum CIMT)
Mean-maximum CIMT is defined as the average of the maximum CIMT values obtained from the far wall of the left and right common carotid arteries, each derived from six measurements taken across three projections (lateral, anterior, and posterior) at 1 cm proximal to the carotid bifurcation, measured by high-resolution B-mode carotid ultrasonography.
Measured: Baseline and 24 weeks
Secondary outcomes (25)
Change from Baseline in Mean Carotid Intima-Media Thickness (avgCIMT)
Mean CIMT (avgCIMT) is defined as the average of all twelve individual IMT measurements obtained from the far wall of the left and right common carotid arteries (six measurements per side), measured by high-resolution B-mode carotid ultrasonography.
Measured: Baseline and 24 weeks
Change from Baseline in Carotid Plaque Volume
Carotid plaque volume is measured using 3D plaque volume software following standard acquisition protocol in participants with identified carotid plaque on ultrasonography.
Measured: Baseline and 24 weeks
Change from Baseline in Endothelial Function (Flow-Mediated Dilation)
Endothelial function is assessed by flow-mediated dilation (FMD) of the brachial artery using high-resolution ultrasound, expressed as the percentage change in brachial artery diameter following reactive hyperaemia.
Measured: Baseline and 24 weeks
Change from Baseline in Microvascular Reactivity (Reactive Hyperaemia Index)
Microvascular reactivity is assessed by the reactive hyperaemia index (RHI) measured using EndoPAT, a non-invasive device that quantifies peripheral arterial tone response to forearm occlusion.
Measured: Baseline and 24 weeks
Change from Baseline in Arterial Stiffness (Pulse Wave Velocity)
Arterial stiffness is assessed by carotid-femoral pulse wave velocity (PWV) measured using SphygmoCor XCEL, a validated applanation tonometry-based device.
Measured: Baseline and 24 weeks
Change from Baseline in Arterial Stiffness (Cardio-Ankle Vascular Index)
Arterial stiffness is additionally assessed by the cardio-ankle vascular index (CAVI), a measure of arterial stiffness from the origin of the aorta to the ankle that is less dependent on blood pressure at the time of measurement.
Measured: Baseline and 24 weeks
Change from Baseline in Skin Advanced Glycation End Products (Skin Autofluorescence)
Tissue advanced glycation end product (AGE) accumulation is measured non-invasively using the AGE Reader, which quantifies skin autofluorescence using ultraviolet light excitation.
Measured: Baseline and 24 weeks
Change from Baseline in Retinal Layer Thickness (Optical Coherence Tomography)
Retinal layer thickness is measured by optical coherence tomography (OCT) as a surrogate of retinal and systemic microvascular health.
Measured: Baseline and 24 weeks
Change from Baseline in Retinal Microvascular Density (Optical Coherence Tomography Angiography)
Retinal microvascular density is measured by optical coherence tomography angiography (OCTA) as a surrogate of systemic microvascular health.
Measured: Baseline and 24 weeks
Change from Baseline in High-Sensitivity C-Reactive Protein (hsCRP)
Serum high-sensitivity C-reactive protein (hsCRP) is measured as a marker of systemic inflammation.
Measured: Baseline and 24 weeks
Change from Baseline in Interleukin-6 (IL-6)
Plasma interleukin-6 (IL-6) is measured as a marker of systemic inflammation and cytokine activity.
Measured: Baseline and 24 weeks
Change from Baseline in Plasminogen Activator Inhibitor-1 (PAI-1)
Plasma plasminogen activator inhibitor-1 (PAI-1) is measured as a marker of impaired fibrinolysis and endothelial dysfunction.
Measured: Baseline and 24 weeks
Change from Baseline in Cell-Free DNA (NETosis Marker)
Plasma cell-free DNA is measured as a marker of neutrophil extracellular trap (NET) formation and neutrophil-mediated inflammatory activity.
Measured: Baseline and 24 weeks
Change from Baseline in Citrullinated Histone H3 (NETosis Marker)
Plasma citrullinated histone H3 is measured as a specific marker of neutrophil extracellular trap (NET) formation and NETosis.
Measured: Baseline and 24 weeks
Change from Baseline in E-selectin
Plasma E-selectin is measured as a marker of endothelial activation and inflammation.
Measured: Baseline and 24 weeks
Change from Baseline in Intercellular Adhesion Molecule-1 (ICAM-1)
Plasma ICAM-1 is measured as a marker of endothelial activation and leucocyte adhesion.
Measured: Baseline and 24 weeks
Change from Baseline in Vascular Cell Adhesion Molecule-1 (VCAM-1)
Plasma VCAM-1 is measured as a marker of endothelial activation and vascular inflammation.
Measured: Baseline and 24 weeks
Change from Baseline in Oxidative Stress Index
An integrated oxidative stress index is derived from nuclear magnetic resonance (NMR)-based redox profiling of plasma and erythrocytes, providing a composite measure of systemic oxidative stress.
Measured: Baseline and 24 weeks
Change from Baseline in Thrombotic Potential (Clot Waveform Analysis)
Clot waveform analysis is performed to characterise the kinetics of clot formation and fibrinolysis in plasma as a measure of overall thrombotic potential.
Measured: Baseline and 24 weeks
Change from Baseline in Von Willebrand Factor Antigen (VWF:Ag)
Plasma von Willebrand factor antigen (VWF:Ag) is measured as a marker of endothelial activation and thrombotic risk.
Measured: Baseline and 24 weeks
Change from Baseline in Von Willebrand Factor Activity (VWF:Act)
Plasma von Willebrand factor activity (VWF:Act) is measured as a functional marker of thrombotic risk and platelet adhesion capacity.
Measured: Baseline and 24 weeks
Change from Baseline in Factor VIII
Plasma factor VIII levels are measured as a marker of coagulation activation and thrombotic potential.
Measured: Baseline and 24 weeks
Change from Baseline in Thrombin Generation
Thrombin generation is measured using a calibrated automated thrombogram to assess overall coagulation potential and thrombotic risk.
Measured: Baseline and 24 weeks
Change from Baseline in Oxidised LDL (Ox-LDL)
Plasma oxidised LDL (Ox-LDL) is measured by nuclear magnetic resonance (NMR) spectroscopy as a marker of lipid oxidation and atherogenic risk.
Measured: Baseline and 24 weeks
Change from Baseline in Atherogenic Lipid Subfractions
Atherogenic lipid subfractions are characterised by nuclear magnetic resonance (NMR) spectroscopy, providing detailed lipoprotein particle profiling beyond standard lipid panels.
Measured: Baseline and 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Sep 2026
- Study start24 Jul 2025
- Primary completion31 Jul 2027 (estimated)
- Study completion31 Jul 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Type 2 Diabetes Mellitus (T2DM)Studies 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
- Interventional
- Phase
- Phase 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Tan Tock Seng Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- Nanyang Technological University
- Responsible party
- Sponsor
- Investigators
- Rinkoo Dalan, MD, PhD, Principal investigator, Tan Tock Seng Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07837934
- Sponsor's protocol ID
- NHG Health DSRB Ref: 2024-3120
- Acronym
- Col-DM
- Status last verified
- Aug 2026
- First submitted
- 6 Sep 2026
- Last updated
- 24 Sep 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The individual participant data will not be publicly shared due to patient confidentiality restrictions and institutional data governance requirements. Researchers seeking access for secondary analyses may contact the study team to discuss feasibility, subject to a formal data sharing or research collaboration agreement with the institution.
Study at a glance
From the registry record, last updated by the sponsor on 24 Sep 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Role of Colchicine in Preventing Atherosclerotic Cardiovascular Disease in Type 2 Diabetes (Col-DM Study)
- ClinicalTrials.gov ID
- NCT07837934
- Acronym / sponsor ID
- Col-DM / NHG Health DSRB Ref: 2024-3120
- Keywords
- Colchicine, Inflammation, Neutrophils, Carotid Intima-Media Thickness, Primary Prevention
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Tan Tock Seng HospitalUniversity, hospital or other
- Collaborators
- Nanyang Technological University
- Study start
- 24 Jul 2025 (actual)
- Primary completion
- 31 Jul 2027 (estimated)
- Study completion
- 31 Jul 2027 (estimated)
- First posted
- 24 Sep 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.
This study will test whether a low-cost anti-inflammatory medicine called colchicine can help protect the blood vessels of people with type 2 diabetes. Diabetes speeds up hardening of the arteries (atherosclerosis), partly because of ongoing low-grade inflammation. Colchicine has already been shown to help prevent heart attacks and strokes in people who already have heart disease; this study looks at whether it can also help prevent early blood vessel damage before heart disease develops. Around 300 adults with type 2 diabetes will be randomly assigned to take colchicine or a placebo (dummy pill) once daily for 24 weeks, in addition to their usual diabetes and heart-risk medications. Neither participants nor the study team will know who is taking colchicine or placebo. The main measurement will be the change in the thickness of the wall of the neck (carotid) artery, measured by ultrasound, which is an early sign of blood vessel disease. The study will also look at markers of inflammation in the blood, blood vessel stiffness and function, and changes in the gut bacteria.
Detailed description
Cardiovascular disease remains the leading cause of death in T2DM, occurring earlier and at substantially higher rates than in the general population. Despite optimisation of conventional risk factors, residual cardiovascular risk remains high, with chronic low-grade inflammation driven by dysregulated neutrophil activity recognised as a key contributor. Patients with T2DM exhibit a distinct pro-inflammatory neutrophil phenotype characterised by increased neutrophil extracellular trap (NET) formation, heightened endothelial adherence, and altered rolling kinetics, which correlates with impaired vascular function and subclinical atherosclerosis.
Colchicine inhibits neutrophil activation, migration, and NET formation, and has demonstrated efficacy in secondary cardiovascular prevention in large randomised trials. Evidence in primary prevention, particularly in T2DM, remains limited. Col-DM takes a precision medicine approach, hypothesising that colchicine's benefit will be concentrated among T2DM patients with a high-risk inflamed neutrophil signature rather than being uniform across the broader population.
Col-DM is a 24-week, parallel-group, Phase 2 randomised controlled trial. Adults with T2DM and no prior atherosclerotic cardiovascular disease are randomised 1:1 to colchicine 0.5 mg daily or matched placebo, stratified by neutrophil inflammatory phenotype classified using a microfluidic organ-on-chip platform. The primary outcome is progression of carotid intima-media thickness (CIMT), estimated overall and separately within each neutrophil-signature stratum. Secondary outcomes cover vascular function, inflammatory and oxidative stress biomarkers, and thrombotic potential. Gut microbiome composition is examined as an exploratory outcome. All outcome measures are estimated overall and separately within each neutrophil-signature stratum. Safety is monitored by an independent Data and Safety Monitoring Committee.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Colchicine | Experimental | Drug: Colchicine 0.5 MG Oral Tablet Once DailyColchicine 0.5 mg orally once daily for 24 weeks, in addition to usual risk-factor-based therapy |
| Placebo | Placebo comparator | Drug: PlaceboMatched placebo orally once daily for 24 weeks, in addition to usual risk-factor-based therapy |
Who may qualify
- Ages
- 21 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- T2DM on stable diabetes medications (no change in last 3 months)
- At least one other comorbidity of hypertension, dyslipidaemia and/or obesity (BMI ≥27), with no previous history of ASCVD
- Able to provide informed consent
Key exclusion criteria (17 listed)
- Recent hospitalization or acute infections within last 2 weeks.
- Current Treatment with corticosteroids or immunosuppressive agents
- Pre-existing malignancies or other terminal conditions with limited prognosis
- Pregnancy
- Breastfeeding
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Colchicine 0.5 MG Oral Tablet Once DailyFor 24 weeks | Drug | Colchicine |
| PlaceboMatched placebo tablets (identical in size, shape, taste, and packaging to colchicine), once daily, for 24 weeks | Drug | Placebo |
Primary outcome
Change from Baseline in Mean-Maximum Carotid Intima-Media Thickness (Mean-Maximum CIMT)
Time frame: Baseline and 24 weeks
Mean-maximum CIMT is defined as the average of the maximum CIMT values obtained from the far wall of the left and right common carotid arteries, each derived from six measurements taken across three projections (lateral, anterior, and posterior) at 1 cm proximal to the carotid bifurcation, measured by high-resolution B-mode carotid ultrasonography.
25 secondary outcomes
Change from Baseline in Mean Carotid Intima-Media Thickness (avgCIMT)
Time frame: Baseline and 24 weeks
Change from Baseline in Carotid Plaque Volume
Time frame: Baseline and 24 weeks
Change from Baseline in Endothelial Function (Flow-Mediated Dilation)
Time frame: Baseline and 24 weeks
Change from Baseline in Microvascular Reactivity (Reactive Hyperaemia Index)
Time frame: Baseline and 24 weeks
Change from Baseline in Arterial Stiffness (Pulse Wave Velocity)
Time frame: Baseline and 24 weeks
Change from Baseline in Arterial Stiffness (Cardio-Ankle Vascular Index)
Time frame: Baseline and 24 weeks
Change from Baseline in Skin Advanced Glycation End Products (Skin Autofluorescence)
Time frame: Baseline and 24 weeks
Change from Baseline in Retinal Layer Thickness (Optical Coherence Tomography)
Time frame: Baseline and 24 weeks
Change from Baseline in Retinal Microvascular Density (Optical Coherence Tomography Angiography)
Time frame: Baseline and 24 weeks
Change from Baseline in High-Sensitivity C-Reactive Protein (hsCRP)
Time frame: Baseline and 24 weeks
Change from Baseline in Interleukin-6 (IL-6)
Time frame: Baseline and 24 weeks
Change from Baseline in Plasminogen Activator Inhibitor-1 (PAI-1)
Time frame: Baseline and 24 weeks
Change from Baseline in Cell-Free DNA (NETosis Marker)
Time frame: Baseline and 24 weeks
Change from Baseline in Citrullinated Histone H3 (NETosis Marker)
Time frame: Baseline and 24 weeks
Change from Baseline in E-selectin
Time frame: Baseline and 24 weeks
Change from Baseline in Intercellular Adhesion Molecule-1 (ICAM-1)
Time frame: Baseline and 24 weeks
Change from Baseline in Vascular Cell Adhesion Molecule-1 (VCAM-1)
Time frame: Baseline and 24 weeks
Change from Baseline in Oxidative Stress Index
Time frame: Baseline and 24 weeks
Change from Baseline in Thrombotic Potential (Clot Waveform Analysis)
Time frame: Baseline and 24 weeks
Change from Baseline in Von Willebrand Factor Antigen (VWF:Ag)
Time frame: Baseline and 24 weeks
Change from Baseline in Von Willebrand Factor Activity (VWF:Act)
Time frame: Baseline and 24 weeks
Change from Baseline in Factor VIII
Time frame: Baseline and 24 weeks
Change from Baseline in Thrombin Generation
Time frame: Baseline and 24 weeks
Change from Baseline in Oxidised LDL (Ox-LDL)
Time frame: Baseline and 24 weeks
Change from Baseline in Atherogenic Lipid Subfractions
Time frame: Baseline and 24 weeks
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 24 Sep 2026.
- Individual participant dataSharing planned: No. The individual participant data will not be publicly shared due to patient confidentiality restrictions and institutional data governance requirements. Researchers seeking access for secondary analyses may contact the study team to discuss feasibility, subject to a formal data sharing or research collaboration agreement with the institution.
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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.
Shirley Lin Shangmei contact
Rinkoo Dalan, MD, PhD principal investigator
Tan Tock Seng Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Colchicine 0.5 MG Oral Tablet Once Daily in people with Type 2 Diabetes Mellitus (T2DM) and Atherosclerosis, run by Tan Tock Seng Hospital at 1 site in Singapore.
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 3 inclusion and 17 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: looking for participants now, as of the sponsor's last update on 24 Sep 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Singapore. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Sanchalika Acharyya, PhD, MPH (96150202, sanchalika.acharyya@nhghealth.com.sg), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change from Baseline in Mean-Maximum Carotid Intima-Media Thickness (Mean-Maximum CIMT) (time frame: Baseline and 24 weeks). 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 24 Sep 2026.