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

20. September 2026 aktualisiert von: 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.

Studienübersicht

Status

Rekrutierung

Bedingungen

Intervention / Behandlung

Detaillierte Beschreibung

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.

Studientyp

Interventionell

Einschreibung (Geschätzt)

300

Phase

  • Phase 2

Kontakte und Standorte

Dieser Abschnitt enthält die Kontaktdaten derjenigen, die die Studie durchführen, und Informationen darüber, wo diese Studie durchgeführt wird.

Studienkontakt

Studieren Sie die Kontaktsicherung

Studienorte

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

Teilnahmekriterien

Forscher suchen nach Personen, die einer bestimmten Beschreibung entsprechen, die als Auswahlkriterien bezeichnet werden. Einige Beispiele für diese Kriterien sind der allgemeine Gesundheitszustand einer Person oder frühere Behandlungen.

Zulassungskriterien

Studienberechtigtes Alter

21 Jahre bis 80 Jahre (Erwachsene, Älterer Erwachsener)

Akzeptiert gesunde Freiwillige

Nein

Studienberechtigte Geschlechter

Alle

Beschreibung

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

Studienplan

Dieser Abschnitt enthält Einzelheiten zum Studienplan, einschließlich des Studiendesigns und der Messung der Studieninhalte.

Wie ist die Studie aufgebaut?

Designdetails

  • Hauptzweck: Verhütung
  • Zuteilung: Zufällig
  • Interventionsmodell: Parallele Zuordnung
  • Maskierung: Vervierfachen

Waffen und Interventionen

Teilnehmergruppe / Arm
Intervention / Behandlung
Experimental: Colchicine

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

For 24 weeks
Placebo-Komparator: Placebo

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

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

Was misst die Studie?

Primäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change from Baseline in Mean-Maximum Carotid Intima-Media Thickness (Mean-Maximum CIMT)
Zeitfenster: 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

Sekundäre Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change from Baseline in Mean Carotid Intima-Media Thickness (avgCIMT)
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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

Andere Ergebnismessungen

Ergebnis Maßnahme
Maßnahmenbeschreibung
Zeitfenster
Change from Baseline in Gut Microbiome Composition
Zeitfenster: 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)
Zeitfenster: 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
Zeitfenster: 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

Mitarbeiter und Ermittler

Hier finden Sie Personen und Organisationen, die an dieser Studie beteiligt sind.

Sponsor

Tan Tock Seng Hospital

Mitarbeiter

Nanyang Technological University

Ermittler

  • Hauptermittler: Rinkoo Dalan, MD, PhD, Tan Tock Seng Hospital

Studienaufzeichnungsdaten

Diese Daten verfolgen den Fortschritt der Übermittlung von Studienaufzeichnungen und zusammenfassenden Ergebnissen an ClinicalTrials.gov. Studienaufzeichnungen und gemeldete Ergebnisse werden von der National Library of Medicine (NLM) überprüft, um sicherzustellen, dass sie bestimmten Qualitätskontrollstandards entsprechen, bevor sie auf der öffentlichen Website veröffentlicht werden.

Haupttermine studieren

Studienbeginn (Tatsächlich)

24. Juli 2025

Primärer Abschluss (Geschätzt)

31. Juli 2027

Studienabschluss (Geschätzt)

31. Juli 2027

Studienanmeldedaten

Zuerst eingereicht

6. September 2026

Zuerst eingereicht, das die QC-Kriterien erfüllt hat

20. September 2026

Zuerst gepostet (Tatsächlich)

24. September 2026

Studienaufzeichnungsaktualisierungen

Letztes Update gepostet (Tatsächlich)

24. September 2026

Letztes eingereichtes Update, das die QC-Kriterien erfüllt

20. September 2026

Zuletzt verifiziert

1. August 2026

Mehr Informationen

Begriffe im Zusammenhang mit dieser Studie

Schlüsselwörter

Zusätzliche relevante MeSH-Bedingungen

Andere Studien-ID-Nummern

  • NHG Health DSRB Ref: 2024-3120

Plan für individuelle Teilnehmerdaten (IPD)

Planen Sie, individuelle Teilnehmerdaten (IPD) zu teilen?

NEIN

Beschreibung des IPD-Plans

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.

Arzneimittel- und Geräteinformationen, Studienunterlagen

Studiert ein von der US-amerikanischen FDA reguliertes Arzneimittelprodukt

Nein

Studiert ein von der US-amerikanischen FDA reguliertes Geräteprodukt

Nein

Produkt, das in den USA hergestellt und aus den USA exportiert wird

Nein

Diese Informationen wurden ohne Änderungen direkt von der Website clinicaltrials.gov abgerufen. Wenn Sie Ihre Studiendaten ändern, entfernen oder aktualisieren möchten, wenden Sie sich bitte an register@clinicaltrials.gov. Sobald eine Änderung auf clinicaltrials.gov implementiert wird, wird diese automatisch auch auf unserer Website aktualisiert .

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