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Colchicine for Primary Prevention of Cardiovascular Disease in Adults With Type 2 Diabetes (Col-DM)

20 września 2026 zaktualizowane przez: Tan Tock Seng Hospital

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.

Przegląd badań

Status

Rekrutacyjny

Warunki

Interwencja / Leczenie

Szczegółowy opis

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.

Typ studiów

Interwencyjne

Zapisy (Szacowany)

300

Faza

  • Faza 2

Kontakty i lokalizacje

Ta sekcja zawiera dane kontaktowe osób prowadzących badanie oraz informacje o tym, gdzie badanie jest przeprowadzane.

Kontakt w sprawie studiów

Kopia zapasowa kontaktu do badania

Lokalizacje studiów

  • Singapur
    • Singapore
      • Singapore, Singapore, Singapur, 308433
        • Rekrutacyjny
        • Tan Tock Seng Hospital
        • Kontakt:
        • Główny śledczy:
          • Rinkoo Dalan, MD, PhD
        • Pod-śledczy:
          • Ying Jie Chee, MD
        • Pod-śledczy:
          • Rupesh Agrawal, M Med (Ophth), MD (Research)
        • Pod-śledczy:
          • Huiling Liew, MD
        • Pod-śledczy:
          • Ying Shan Lee, MBBS
        • Pod-śledczy:
          • Eugene Fan, MD

Kryteria uczestnictwa

Badacze szukają osób, które pasują do określonego opisu, zwanego kryteriami kwalifikacyjnymi. Niektóre przykłady tych kryteriów to ogólny stan zdrowia danej osoby lub wcześniejsze leczenie.

Kryteria kwalifikacji

Wiek uprawniający do nauki

21 lat do 80 lat (Dorosły, Starszy dorosły)

Akceptuje zdrowych ochotników

Nie

Płeć kwalifikująca się do nauki

Wszystko

Opis

Inclusion Criteria:

  • 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

Exclusion Criteria:

  1. Recent hospitalization or acute infections within last 2 weeks.
  2. Current Treatment with corticosteroids or immunosuppressive agents
  3. Pre-existing malignancies or other terminal conditions with limited prognosis
  4. Pregnancy
  5. Breastfeeding
  6. Inability to provide written consent
  7. Renal impairment (eGFR< 60ml/min)
  8. Liver cirrhosis or ALT/AST >3x ULN
  9. Pharmacogenomics indicative of adverse effects
  10. Hypersensitivity to the active substance or to the following excipients: Lactose, Maize starch, Sodium laurilsulfate, Magnesium stearate
  11. Known blood dyscrasia
  12. Women of childbearing age who are keen to conceive in the next 1 year
  13. Taking a strong P-glycoprotein inhibitor (e.g. cyclosporine, ranolazine) or a strong CYP3A4 inhibitor
  14. Known myositis with raised creatine kinase with statins (statin myopathy).
  15. Gout attack within the last 1 year
  16. Currently taking Aspirin
  17. Taking any oral contraceptives

Plan studiów

Ta sekcja zawiera szczegółowe informacje na temat planu badania, w tym sposób zaprojektowania badania i jego pomiary.

Jak projektuje się badanie?

Szczegóły projektu

  • Główny cel: Zapobieganie
  • Przydział: Randomizowane
  • Model interwencyjny: Przydział równoległy
  • Maskowanie: Poczwórny

Broń i interwencje

Grupa uczestników / Arm
Interwencja / Leczenie
Eksperymentalny: Colchicine

Colchicine 0.5 mg orally once daily for 24 weeks, in addition to usual risk-factor-based therapy
Lek: Colchicine 0.5 MG Oral Tablet Once Daily

For 24 weeks
Komparator placebo: Placebo

Matched placebo orally once daily for 24 weeks, in addition to usual risk-factor-based therapy
Lek: Placebo

Matched placebo tablets (identical in size, shape, taste, and packaging to colchicine), once daily, for 24 weeks

Co mierzy badanie?

Podstawowe miary wyniku

Miara wyniku
Opis środka
Ramy czasowe
Change from Baseline in Mean-Maximum Carotid Intima-Media Thickness (Mean-Maximum CIMT)
Ramy czasowe: 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.
Baseline and 24 weeks

Miary wyników drugorzędnych

Miara wyniku
Opis środka
Ramy czasowe
Change from Baseline in Mean Carotid Intima-Media Thickness (avgCIMT)
Ramy czasowe: Baseline and 24 weeks

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.
Baseline and 24 weeks
Change from Baseline in Carotid Plaque Volume
Ramy czasowe: Baseline and 24 weeks

Carotid plaque volume is measured using 3D plaque volume software following standard acquisition protocol in participants with identified carotid plaque on ultrasonography.
Baseline and 24 weeks
Change from Baseline in Endothelial Function (Flow-Mediated Dilation)
Ramy czasowe: Baseline and 24 weeks

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.
Baseline and 24 weeks
Change from Baseline in Microvascular Reactivity (Reactive Hyperaemia Index)
Ramy czasowe: Baseline and 24 weeks

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.
Baseline and 24 weeks
Change from Baseline in Arterial Stiffness (Pulse Wave Velocity)
Ramy czasowe: Baseline and 24 weeks

Arterial stiffness is assessed by carotid-femoral pulse wave velocity (PWV) measured using SphygmoCor XCEL, a validated applanation tonometry-based device.
Baseline and 24 weeks
Change from Baseline in Arterial Stiffness (Cardio-Ankle Vascular Index)
Ramy czasowe: Baseline and 24 weeks

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.
Baseline and 24 weeks
Change from Baseline in Skin Advanced Glycation End Products (Skin Autofluorescence)
Ramy czasowe: Baseline and 24 weeks

Tissue advanced glycation end product (AGE) accumulation is measured non-invasively using the AGE Reader, which quantifies skin autofluorescence using ultraviolet light excitation.
Baseline and 24 weeks
Change from Baseline in Retinal Layer Thickness (Optical Coherence Tomography)
Ramy czasowe: Baseline and 24 weeks

Retinal layer thickness is measured by optical coherence tomography (OCT) as a surrogate of retinal and systemic microvascular health.
Baseline and 24 weeks
Change from Baseline in Retinal Microvascular Density (Optical Coherence Tomography Angiography)
Ramy czasowe: Baseline and 24 weeks

Retinal microvascular density is measured by optical coherence tomography angiography (OCTA) as a surrogate of systemic microvascular health.
Baseline and 24 weeks
Change from Baseline in High-Sensitivity C-Reactive Protein (hsCRP)
Ramy czasowe: Baseline and 24 weeks

Serum high-sensitivity C-reactive protein (hsCRP) is measured as a marker of systemic inflammation.
Baseline and 24 weeks
Change from Baseline in Interleukin-6 (IL-6)
Ramy czasowe: Baseline and 24 weeks

Plasma interleukin-6 (IL-6) is measured as a marker of systemic inflammation and cytokine activity.
Baseline and 24 weeks
Change from Baseline in Plasminogen Activator Inhibitor-1 (PAI-1)
Ramy czasowe: Baseline and 24 weeks

Plasma plasminogen activator inhibitor-1 (PAI-1) is measured as a marker of impaired fibrinolysis and endothelial dysfunction.
Baseline and 24 weeks
Change from Baseline in Cell-Free DNA (NETosis Marker)
Ramy czasowe: Baseline and 24 weeks

Plasma cell-free DNA is measured as a marker of neutrophil extracellular trap (NET) formation and neutrophil-mediated inflammatory activity.
Baseline and 24 weeks
Change from Baseline in Citrullinated Histone H3 (NETosis Marker)
Ramy czasowe: Baseline and 24 weeks

Plasma citrullinated histone H3 is measured as a specific marker of neutrophil extracellular trap (NET) formation and NETosis.
Baseline and 24 weeks
Change from Baseline in E-selectin
Ramy czasowe: Baseline and 24 weeks

Plasma E-selectin is measured as a marker of endothelial activation and inflammation.
Baseline and 24 weeks
Change from Baseline in Intercellular Adhesion Molecule-1 (ICAM-1)
Ramy czasowe: Baseline and 24 weeks

Plasma ICAM-1 is measured as a marker of endothelial activation and leucocyte adhesion.
Baseline and 24 weeks
Change from Baseline in Vascular Cell Adhesion Molecule-1 (VCAM-1)
Ramy czasowe: Baseline and 24 weeks

Plasma VCAM-1 is measured as a marker of endothelial activation and vascular inflammation.
Baseline and 24 weeks
Change from Baseline in Oxidative Stress Index
Ramy czasowe: Baseline and 24 weeks

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.
Baseline and 24 weeks
Change from Baseline in Thrombotic Potential (Clot Waveform Analysis)
Ramy czasowe: Baseline and 24 weeks

Clot waveform analysis is performed to characterise the kinetics of clot formation and fibrinolysis in plasma as a measure of overall thrombotic potential.
Baseline and 24 weeks
Change from Baseline in Von Willebrand Factor Antigen (VWF:Ag)
Ramy czasowe: Baseline and 24 weeks

Plasma von Willebrand factor antigen (VWF:Ag) is measured as a marker of endothelial activation and thrombotic risk.
Baseline and 24 weeks
Change from Baseline in Von Willebrand Factor Activity (VWF:Act)
Ramy czasowe: Baseline and 24 weeks

Plasma von Willebrand factor activity (VWF:Act) is measured as a functional marker of thrombotic risk and platelet adhesion capacity.
Baseline and 24 weeks
Change from Baseline in Factor VIII
Ramy czasowe: Baseline and 24 weeks

Plasma factor VIII levels are measured as a marker of coagulation activation and thrombotic potential.
Baseline and 24 weeks
Change from Baseline in Thrombin Generation
Ramy czasowe: Baseline and 24 weeks

Thrombin generation is measured using a calibrated automated thrombogram to assess overall coagulation potential and thrombotic risk.
Baseline and 24 weeks
Change from Baseline in Oxidised LDL (Ox-LDL)
Ramy czasowe: Baseline and 24 weeks

Plasma oxidised LDL (Ox-LDL) is measured by nuclear magnetic resonance (NMR) spectroscopy as a marker of lipid oxidation and atherogenic risk.
Baseline and 24 weeks
Change from Baseline in Atherogenic Lipid Subfractions
Ramy czasowe: Baseline and 24 weeks

Atherogenic lipid subfractions are characterised by nuclear magnetic resonance (NMR) spectroscopy, providing detailed lipoprotein particle profiling beyond standard lipid panels.
Baseline and 24 weeks

Inne miary wyników

Miara wyniku
Opis środka
Ramy czasowe
Change from Baseline in Gut Microbiome Composition
Ramy czasowe: Baseline and 24 weeks

Gut microbiome composition is characterised from stool samples by metagenomic sequencing, to examine whether colchicine-associated shifts in microbial composition relate to treatment response.
Baseline and 24 weeks
Change from Baseline in Plasma Metabolite Profile (Metabolomics)
Ramy czasowe: Baseline and 24 weeks

As an exploratory analysis, plasma metabolomic profiling will be performed on stored blood samples to characterise changes in the metabolite profile over 24 weeks.
Baseline and 24 weeks
Incidence of Adverse Events and Serious Adverse Events
Ramy czasowe: From randomisation through 24 weeks

Safety is assessed by the incidence of adverse events (AEs) and serious adverse events (SAEs), defined per standard regulatory criteria, ascertained at each study visit and telephone contact, and adjudicated by an independent Data and Safety Monitoring Committee.
From randomisation through 24 weeks

Współpracownicy i badacze

Tutaj znajdziesz osoby i organizacje zaangażowane w to badanie.

Sponsor

Tan Tock Seng Hospital

Współpracownicy

Nanyang Technological University

Śledczy

  • Główny śledczy: Rinkoo Dalan, MD, PhD, Tan Tock Seng Hospital

Daty zapisu na studia

Daty te śledzą postęp w przesyłaniu rekordów badań i podsumowań wyników do ClinicalTrials.gov. Zapisy badań i zgłoszone wyniki są przeglądane przez National Library of Medicine (NLM), aby upewnić się, że spełniają określone standardy kontroli jakości, zanim zostaną opublikowane na publicznej stronie internetowej.

Główne daty studiów

Rozpoczęcie studiów (Rzeczywisty)

24 lipca 2025

Zakończenie podstawowe (Szacowany)

31 lipca 2027

Ukończenie studiów (Szacowany)

31 lipca 2027

Daty rejestracji na studia

Pierwszy przesłany

6 września 2026

Pierwszy przesłany, który spełnia kryteria kontroli jakości

20 września 2026

Pierwszy wysłany (Rzeczywisty)

24 września 2026

Aktualizacje rekordów badań

Ostatnia wysłana aktualizacja (Rzeczywisty)

24 września 2026

Ostatnia przesłana aktualizacja, która spełniała kryteria kontroli jakości

20 września 2026

Ostatnia weryfikacja

1 sierpnia 2026

Więcej informacji

Terminy związane z tym badaniem

Słowa kluczowe

Dodatkowe istotne warunki MeSH

Inne numery identyfikacyjne badania

  • NHG Health DSRB Ref: 2024-3120

Plan dla danych uczestnika indywidualnego (IPD)

Planujesz udostępniać dane poszczególnych uczestników (IPD)?

NIE

Opis planu IPD

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.

Informacje o lekach i urządzeniach, dokumenty badawcze

Bada produkt leczniczy regulowany przez amerykańską FDA

Nie

Bada produkt urządzenia regulowany przez amerykańską FDA

Nie

produkt wyprodukowany i wyeksportowany z USA

Nie

Te informacje zostały pobrane bezpośrednio ze strony internetowej clinicaltrials.gov bez żadnych zmian. Jeśli chcesz zmienić, usunąć lub zaktualizować dane swojego badania, skontaktuj się z register@clinicaltrials.gov. Gdy tylko zmiana zostanie wprowadzona na stronie clinicaltrials.gov, zostanie ona automatycznie zaktualizowana również na naszej stronie internetowej .

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