Colchicine for Primary Prevention of Cardiovascular Disease in Adults With Type 2 Diabetes
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age21-80
SponsorTan Tock Seng Hospital
About this trial
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.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Colchicine 0.5 MG Oral Tablet Once Daily
DrugFor 24 weeks
Placebo
DrugMatched placebo tablets (identical in size, shape, taste, and packaging to colchicine), once daily, for 24 weeks
Treatment groups
300 Participants
are divided into 2 treatment groupsGroup A: ColchicineExperimental treatment 1 intervention
Group B: PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
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.
Time frame
Baseline and 24 weeksSecondary outcomes
1
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.
Time frame
Baseline and 24 weeks2
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.
Time frame
Baseline and 24 weeks3
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.
Time frame
Baseline and 24 weeks4
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.
Time frame
Baseline and 24 weeksOther outcomes
1
Change from Baseline in Gut Microbiome Composition
Gut microbiome composition is characterised from stool samples by metagenomic sequencing, to examine whether colchicine-associated shifts in microbial composition relate to treatment response.
Time frame
Baseline and 24 weeks2
Change from Baseline in Plasma Metabolite Profile (Metabolomics)
As an exploratory analysis, plasma metabolomic profiling will be performed on stored blood samples to characterise changes in the metabolite profile over 24 weeks.
Time frame
Baseline and 24 weeks3
Incidence of Adverse Events and Serious Adverse Events
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.
Time frame
From randomisation through 24 weeksSponsors and contacts
Click on the lead sponsor to view all of their trials.
Tan Tock Seng Hospital
Lead sponsor
Nanyang Technological University
Collaborator
Source ClinicalTrials.gov