Cardiovascular Diseases Clinical Trial
— REC1TEOfficial title:
Repurposing Colchicine for Reduction of Residual Inflammatory Risk in Type 1 Diabetes: A Randomized, Double-blind, Placebo-controlled, Investigator-initiated Trial
The aim of this clinical trial is to evaluate if colchicine in addition to standard of care improves markers of inflammation and cardiovascular disease in persons with type 1 diabetes. Participants will be assigned to either 0,5 mg colchicine daily or placebo in a 1:1 ratio for 26 weeks.
Status | Recruiting |
Enrollment | 100 |
Est. completion date | June 15, 2026 |
Est. primary completion date | June 15, 2026 |
Accepts healthy volunteers | No |
Gender | All |
Age group | 35 Years to 80 Years |
Eligibility | Inclusion Criteria: - Type 1 diabetes for more than five years according to World Health Organization criteria - Age 35-80 years - Hemoglobin A1c < 80 mmol/mol - Stable insulin therapy (defined as no change in insulin brand and no newly initiated continous subcutaneus insulin infusion (CSII) or multiple-daily injection (MDI) therapy) and, if applicable, stable usage of glucose monitoring technology (e.g., continous glucose monitor (CGM) or intermittently scanned CGM) = 3 months with either MDI or CSII - CRP = 2 mg/L (measured by high-sensitivity assay) - eGFR > 50 mL/min/L/1.73 m^2 - Either stable arteriosclerotic cardiovascular disease (ASCVD) (as defined by ischemic heart disease including previous acute myocardial infarction, acute coronary syndrome and coronary revascularization; other arterial revascularization procedures; stroke and transient ischemic attack; aortic aneurysm; peripheral arterial disease, including carotid atherosclerosis) - and/or risk of cardiovascular (CV) death > 5 % within 10 years (i.e., high or very high CV risk) as defined by the European Society of Cardiology or 10-year CV risk = 20 % (i.e., high CV risk) as according to 'Steno Type 1 Diabetes Risk Engine' (https://steno.shinyapps.io/T1RiskEngine/) Exclusion Criteria: - Hypoglycemia unawareness (inability to register low blood glucose) am modum Pedersen-Bjergaard, unless usage of CGM with alarm function - Liver disease with elevated plasma alanine aminotransferase (ALT) > three times the upper limit of normal (measured at screening with the possibility of one repeat analysis within seven days, and the last measured value as being conclusive) - History of cirrhosis, chronic active hepatitis or severe hepatic disease - Inflammatory bowel disease or chronic diarrhea - Pre-existing progressive neuromuscular disease or persons with creatinine kinase levels > three times the upper limit of normal (measured at screening with the possibility of one repeat analysis within a week, and the last measured value as being conclusive) - Cancer or lymphoproliferative disease unless in complete remission for > 5 years - Immunosuppressive therapy or state of chronic immunodeficiency, including infection with human immunodeficiency virus (HIV) - Blood dyscrasias (e.g., myelodysplastic syndromes or related hematological disorders) - Leukocyte cell count < 3.0 X 10^9/L - Thrombocyte count < 110 X 10^9/L - Systemic (oral or intravenous), long-term steroid therapy (topical or inhaled steroids are allowed) - Hemodialysis or peritoneal dialysis therapy (since colchicine cannot be removed by dialysis or exchange transfusion) - Renal or hepatic impairment treated with a P-gp inhibitor or a strong CYP3A4 inhibitor - Intake of grapefruit juice during trial participation - Other concomitant disease or treatment that according to the investigator's assessment makes the person unsuitable for study participation - Alcohol/drug abuse - Fertile women not using hormonal (tablet/pill, depot injection of progesterone, subdermal gestagen implantation, hormone intrauterine devices (IUD), hormonal vaginal ring or transdermal hormonal patch), chemical (copper IUD) or mechanical (condom, femidom, sterilization) contraceptives - Pregnant or nursing women - On permanent treatment with colchicine that is not discontinued within 30 days of screening visit - Known or suspected hypersensitivity to colchicine - Receipt of any investigational drug within 30 days prior to screening visit - Simultaneous participation in any other clinical intervention trial |
Country | Name | City | State |
---|---|---|---|
Denmark | Center for Clinical Metabolic Research, Gentofte Hospital | Hellerup | Capital Region |
Lead Sponsor | Collaborator |
---|---|
Filip Krag Knop | Juvenile Diabetes Research Foundation, University of Copenhagen |
Denmark,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Other | Change in fasting serum/plasma concentrations of fibrinogen (µmol/L) | %-point | From week 0 (baseline) to week 30 (safety follow-up) | |
Other | Change in fasting serum/plasma concentrations of serum amyloid A (mg/L) | %-point | From week 0 (baseline) to week 30 (safety follow-up) | |
Other | Change in fasting serum/plasma concentrations of haptoglobin (g/L) | %-point | From week 0 (baseline) to week 30 (safety follow-up) | |
Other | Change in fasting serum/plasma concentrations of interleukin (IL)-1ß (pg/mL) | %-point | From week 0 (baseline) to week 30 (safety follow-up) | |
Other | Change in fasting serum/plasma concentrations of interleukin (IL)-2 (pg/mL) | %-point | From week 0 (baseline) to week 30 (safety follow-up) | |
Other | Change in fasting serum/plasma concentrations of intercellular adhesion molecule 1 (ICAM-1) (pg/mL) | %-point | From week 0 (baseline) to week 30 (safety follow-up) | |
Other | Change in fasting serum/plasma concentrations of vascular cell adhesion molecule 1 (VCAM-1) (pg/mL) | %-point | From week 0 (baseline) to week 30 (safety follow-up) | |
Other | Change in fasting serum/plasma concentrations of total leukocyte count, including neutrophil, lymphocyte, basophil and eosinophil counts (10^9/L) | %-point | From week 0 (baseline) to week 30 (safety follow-up) | |
Other | Change in neutrophil:lymphocyte ratio | %-point | From week 0 (baseline) to week 30 (safety follow-up) | |
Other | Change in fasting serum/plasma concentrations of very low-density lipoprotein (VLDL) cholesterol (mmol/L) | %-point | From week 0 (baseline) to week 30 (safety follow-up) | |
Other | Change in fasting serum/plasma concentrations of high-density lipoprotein (HDL) cholesterol (mmol/L) | %-point | From week 0 (baseline) to week 30 (safety follow-up) | |
Other | Change in fasting serum/plasma concentrations of total cholesterol (mmol/L) | %-point | From week 0 (baseline) to week 30 (safety follow-up) | |
Other | Change in fasting serum/plasma concentrations of triglycerides (mmol/L) | %-point | From week 0 (baseline) to week 30 (safety follow-up) | |
Other | Change in fasting serum/plasma concentrations of lipoprotein (a) (mg/L) | %-point | From week 0 (baseline) to week 30 (safety follow-up) | |
Other | Change in thrombocyte function measured by thromboelastography | %-point | From week 0 (baseline) to week 26 (end of treatment) | |
Other | Change in fasting serum/plasma concentrations of N-terminal pro-brain natriuretic peptide (pro-BNP) (pmol/L) | %-point | From week 0 (baseline) to week 30 (end of treatment) | |
Other | Change in consultation blood pressure (mmHg) | %-point | From week 0 (baseline) to week 30 (end of treatment) | |
Other | Change in heart rate (beats/minute) | %-point | From week 0 (baseline) to week 30 (end of treatment) | |
Other | Change in fasting serum/plasma concentrations of estimated glomerular filtration rate (eGFR) (mL/min/1.73 m2) | %-point | From week 0 (baseline) to week 30 (end of treatment) | |
Other | Change in fasting serum/plasma concentrations of albumin (g/L) | %-point | From week 0 (baseline) to week 30 (end of treatment) | |
Other | Change in urine albumin-to-creatinine ratio (mg/g) | %-point | From week 0 (baseline) to week 26 (end of treatment) | |
Other | Change left ventricular (LV) mass index evaluated by cardiovascular ultrasonography (g/m^2) | %-point | From week 0 (baseline) to week 26 (end of treatment) | |
Other | Change left ventricular (LV) septal wall thickness evaluated by cardiovascular ultrasonography (mm) | %-point | From week 0 (baseline) to week 26 (end of treatment) | |
Other | Change left ventricular (LV) posterior wall thickness evaluated by cardiovascular ultrasonography (mm) | %-point | From week 0 (baseline) to week 26 (end of treatment) | |
Other | Change left ventricular (LV) ejection fraction (LVEF) evaluated by cardiovascular ultrasonography (%) | %-point | From week 0 (baseline) to week 26 (end of treatment) | |
Other | Change ratio of peak velocity blood flow from left ventricular relaxation in early diastole (E) to peak velocity flow in late diastole caused by atrial contraction (A) (E/A ratio) evaluated by cardiovascular ultrasonography | %-point | From week 0 (baseline) to week 26 (end of treatment) | |
Other | Change early diastolic mitral inflow velocity (e') evaluated by cardiovascular ultrasonography (m/sec) | %-point | From week 0 (baseline) to week 26 (end of treatment) | |
Other | Change ratio of early diastolic mitral inflow velocity (e') to early diastolic mitral annulus velocity (E) (E/e' ratio) evaluated by cardiovascular ultrasonography | %-point | From week 0 (baseline) to week 26 (end of treatment) | |
Other | Change ratio of early mitral inflow velocity (E) to global diastolic strain rate (e' sr) (E/e'sr ratio) evaluated by cardiovascular ultrasonography | %-point | From week 0 (baseline) to week 26 (end of treatment) | |
Other | Change left atrial volume (LAVi) evaluated by cardiovascular ultrasonography (mL) | %-point | From week 0 (baseline) to week 26 (end of treatment) | |
Other | Change global longitudinal strain (GLS) evaluated by cardiovascular ultrasonography (%) | %-point | From week 0 (baseline) to week 26 (end of treatment) | |
Other | Change aortic distensibility evaluated by cardiovascular ultrasonography (mmHg^-1) | %-point | From week 0 (baseline) to week 26 (end of treatment) | |
Other | Change aortic strain evaluated by cardiovascular ultrasonography (%) | %-point | From week 0 (baseline) to week 26 (end of treatment) | |
Other | Change in mean glucose evaluated by a continous glucose monitor (mmol/L) | %-point | From week 0 (baseline) to week 26 (end of treatment) | |
Other | Change in standard deviation evaluated by a continous glucose monitor (mmol/L) | %-point | From week 0 (baseline) to week 26 (end of treatment) | |
Other | Change in coefficient of variance evaluated by a continous glucose monitor (> 0.36 defined as glycemic variability) | %-point | From week 0 (baseline) to week 26 (end of treatment) | |
Other | Change in glycemic variability (continuous overall net glycemic action (CONGA)) evaluated by a continous glucose monitor | %-point | From week 0 (baseline) to week 26 (end of treatment) | |
Other | Change in mean amplitude of glycemic excursion evaluated by a continous glucose monitor | %-point | From week 0 (baseline) to week 26 (end of treatment) | |
Other | Change in diabetes treatment satisfactory questionnaire, status version (DTSQs) (From 0 (min) to 6 (max), higher scores indicate a better outcome ) | %-point | From week 0 (baseline) to week 30 (end of treatment) | |
Other | Change in diabetes treatment satisfactory questionnaire, change version (DTSQc) (From -3 (min) to 3 (max), higher scores indicate a better outcome) | %-point | From week 0 (baseline) to week 30 (end of treatment) | |
Other | Change in audit of diabetes-dependent quality of life questionnaire (ADDQoL) (From -9 (min) to 9 (max), higher scores indicate a better outcome ) | %-point | From week 0 (baseline) to week 30 (end of treatment) | |
Other | Change in fasting serum/plasma concentrations of ketones (mmol/L) | %-point | From week 0 (baseline) to week 30 (end of treatment) | |
Other | Adverse events | As reported by participants | From week 0 (baseline) to week 30 (end of treatment) | |
Other | Change in liver fat content as per the CAP score (dB/m) measured by FibroScan® | %-point | From week 0 (baseline) to week 26 (end of treatment) | |
Other | Change in liver fibrosis score (kPa) measured by FibroScan® | %-point | From week 0 (baseline) to week 26 (end of treatment) | |
Other | Change in fibrosis-4 (FIB-4) score (numerical scale, higher scores indicate a higher risk of fibrosis) | %-point | From week 0 (baseline) to week 30 (end of treatment) | |
Other | Change in fatty liver index (FLI) score (numerical scale, higher scores indicate a higher risk of fibrosis) | %-point | From week 0 (baseline) to week 30 (end of treatment) | |
Other | Change in fasting serum/plasma concentrations of hemoglobin (mmol/L) | %-point | From week 0 (baseline) to week 30 (end of treatment) | |
Other | Change in fasting serum/plasma concentrations of thrombocytes (10^9/L) | %-point | From week 0 (baseline) to week 30 (end of treatment) | |
Other | Change in fasting serum/plasma concentrations of glucose (mmol/L) | %-point | From week 0 (baseline) to week 30 (end of treatment) | |
Other | Change in fasting serum/plasma concentrations of potassium (mmol/L) | %-point | From week 0 (baseline) to week 30 (end of treatment) | |
Other | Change in fasting serum/plasma concentrations of sodium (mmol/L) | %-point | From week 0 (baseline) to week 30 (end of treatment) | |
Other | Change in fasting serum/plasma concentrations of creatinine (umol/L) | %-point | From week 0 (baseline) to week 30 (end of treatment) | |
Other | Change in fasting serum/plasma concentrations of alanine aminotransferase (U/L) | %-point | From week 0 (baseline) to week 30 (end of treatment) | |
Other | Change in fasting serum/plasma concentrations of aspartate aminotransferase (U/L) | %-point | From week 0 (baseline) to week 30 (end of treatment) | |
Other | Change in fasting serum/plasma concentrations of bilirubin (umol/L) | %-point | From week 0 (baseline) to week 30 (end of treatment) | |
Other | Change in fasting serum/plasma concentrations of amylase (units/L) | %-point | From week 0 (baseline) to week 30 (end of treatment) | |
Other | Change in fasting serum/plasma concentrations of creatine kinase (U/L) | %-point | From week 0 (baseline) to week 30 (end of treatment) | |
Other | Change in fasting serum/plasma concentrations of C-peptide (pmol/L) | %-point | From week 0 (baseline) to week 30 (end of treatment) | |
Other | Change in fasting serum/plasma concentrations of glucagon (pmol/L) | %-point | From week 0 (baseline) to week 30 (end of treatment) | |
Other | Change in fasting serum/plasma concentrations of C-terminal telopeptide (ng/L) | %-point | From week 0 (baseline) to week 30 (end of treatment) | |
Other | Change in fasting serum/plasma concentrations of procollagen type 1 N-terminal propeptide (ng/L) | %-point | From week 0 (baseline) to week 30 (end of treatment) | |
Other | Change in body composition by bioimpedance analysis | %-point (fat free mass, total fat mass, muscle mass, bone mass) | From week 0 (baseline) to week 26 (end of treatment) | |
Other | Change in body mass index (kg/m^2) | %-point | From week 0 (baseline) to week 30 (end of treatment) | |
Other | Change in waist circumference (cm) | %-point | From week 0 (baseline) to week 30 (end of treatment) | |
Other | Change in hip circumference (cm) | %-point | From week 0 (baseline) to week 30 (end of treatment) | |
Other | Change in waist:hip ratio | %-point | From week 0 (baseline) to week 30 (end of treatment) | |
Other | Change in interleukin messenger ribonucleic acid (mRNA) expression measured by quantitative polymerase chain reaction | %-point | From week 0 (baseline) to week 26 (end of treatment) | |
Primary | Change in fasting serum/plasma concentrations of C-reactive protein (CRP) measured by a high-sensitivity assay (hsCRP) (mg/L) | %-point | From week 0 (baseline) to week 26 (end of treatment) | |
Secondary | Change in fasting serum/plasma concentrations of C-reactive protein (CRP) measured by a high-sensitivity assay (hsCRP) (mg/L) | %-point | From week 0 (baseline) to week 30 (safety follow-up) | |
Secondary | Change in fasting serum/plasma concentrations of hemoglobin A1c (mmol/mol) | %-point | From week 0 (baseline) to week 30 (safety follow-up) | |
Secondary | Time spent in target blood glucose range (3.9 - 10 mmol/L) evaluated by a continous glucose monitor (CGM) | (% of 24 hours) | From week 0 (baseline) to week 26 (end of treatment) | |
Secondary | Time spent in hyperglycemia level 1 (10-13.9 mmol/L) evaluated by a continous glucose monitor (CGM) | (% of 24 hours) | From week 0 (baseline) to week 26 (end of treatment) | |
Secondary | Time spent in hyperglycemia level 2 (> 13.9 mmol/L) evaluated by a continous glucose monitor (CGM) | (% of 24 hours) | From week 0 (baseline) to week 26 (end of treatment) | |
Secondary | Time spent in hypoglycemia level 1 (3.0-3.8 mmol/L) evaluated by a continous glucose monitor (CGM) | (% of 24 hours) | From week 0 (baseline) to week 26 (end of treatment) | |
Secondary | Time spent in hypoglycemia level 2 (< 3.0 mmol/L)evaluated by a continous glucose monitor (CGM) | (% of 24 hours) | From week 0 (baseline) to week 26 (end of treatment) | |
Secondary | Insulin dosage | Number of units/day (both long- and short-acting insulin analogues) | From week 0 (baseline) to week 30 (safety follow-up) | |
Secondary | Change in body weight (kg) | %-point | From week 0 (baseline) to week 30 (safety follow-up) | |
Secondary | Change in waist:hip ratio | %-point | From week 0 (baseline) to week 30 (safety follow-up) | |
Secondary | Change in fasting serum/plasma concentrations of low-density lipoprotein cholesterol (LDL) (mmol/L) | %-point | From week 0 (baseline) to week 30 (safety follow-up) | |
Secondary | Change in fasting serum/plasma concentrations of interleukin (IL)-6 (pg/mL) | %-point | From week 0 (baseline) to week 30 (safety follow-up) | |
Secondary | Change in fasting serum/plasma concentrations of tumor necrosis factor alpha (pg/mL) | %-point | From week 0 (baseline) to week 30 (safety follow-up) | |
Secondary | Safety-related events | Serious adverse events (SAE), events of severe hypoglycemia, events of diabetic ketoacidosis | From week 0 (baseline) to week 30 (safety follow-up) |
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