Cardiovascular Diseases Clinical Trial
Official 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.
The current study aims to evaluate the efficacy of 0.5 mg colchicine once-daily added to existing standard of care in persons with established type 1 diabetes, existing arteriosclerotic cardiovascular disease (CVD) or at high risk thereof and C-reactive protein (CRP) ≥ 2 mg/L. Specifically, the primary objective is to determine the effect of colchicine (0.5 mg/daily) on levels of CRP (as assessed by high-sensitivity assays) as compared with placebo following 26 weeks of treatment. Additionally, the study will investigate the short and long-term effects of colchicine treatment on other markers of CVD and inflammation, markers of metabolism and markers of glycemic control in type 1 diabetes, including glycated hemoglobin (HbA1c), time spent in hypoglycemia (level 1 glucose readings 3.0-3.8 mmol/L and level 2 glucose readings < 3.0 mmol/L), target glycemia (glucose readings 3.9-10 mmol/L) and hyperglycemia (level 1 glucose readings 10.1-13.9 mmol/L and level 2 glucose readings > 13.9 mmol/L) together with measures of glycemic variability evaluated by continuous glucose monitoring (CGM), insulin dosage, risk of hypoglycemia, risk of diabetic ketoacidosis and body weight. ;
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Recruiting |
NCT05654272 -
Development of CIRC Technologies
|
||
| Recruiting |
NCT05650307 -
CV Imaging of Metabolic Interventions
|
||
| Recruiting |
NCT04515303 -
Digital Intervention Participation in DASH
|
||
| Completed |
NCT04056208 -
Pistachios Blood Sugar Control, Heart and Gut Health
|
Phase 2 | |
| Recruiting |
NCT04417387 -
The Genetics and Vascular Health Check Study (GENVASC) Aims to Help Determine Whether Gathering Genetic Information Can Improve the Prediction of Risk of Coronary Artery Disease (CAD)
|
||
| Not yet recruiting |
NCT06032572 -
Evaluation of the Safety and Effectiveness of the VRS100 System in PCI (ESSENCE)
|
N/A | |
| Recruiting |
NCT04514445 -
The BRAVE Study- The Identification of Genetic Variants Associated With Bicuspid Aortic Valve Using a Combination of Case-control and Family-based Approaches.
|
||
| Enrolling by invitation |
NCT04253054 -
Chinese Multi-provincial Cohort Study-Beijing Project
|
||
| Completed |
NCT03273972 -
INvestigating the Lowest Threshold of Vascular bENefits From LDL Lowering With a PCSK9 InhibiTor in healthY Volunteers
|
N/A | |
| Completed |
NCT03680638 -
The Effect of Antioxidants on Skin Blood Flow During Local Heating
|
Phase 1 | |
| Recruiting |
NCT04843891 -
Evaluation of PET Probe [64]Cu-Macrin in Cardiovascular Disease, Cancer and Sarcoidosis.
|
Phase 1 | |
| Completed |
NCT04083846 -
Clinical Study to Investigate the Pharmacokinetic Profiles and Safety of High-dose CKD-385 in Healthy Volunteers(Fed)
|
Phase 1 | |
| Completed |
NCT04083872 -
Clinical Study to Investigate the Pharmacokinetic Profiles and Safety of Highdose CKD-385 in Healthy Volunteers(Fasting)
|
Phase 1 | |
| Completed |
NCT03619148 -
The Incidence of Respiratory Symptoms Associated With the Use of HFNO
|
N/A | |
| Completed |
NCT03466333 -
Postnatal Enalapril to Improve Cardiovascular fUnction Following Preterm Pre-eclampsia
|
Phase 2 | |
| Completed |
NCT03693365 -
Fluid Responsiveness Tested by the Effective Pulmonary Blood Flow During a Positive End-expiratory Trial
|
||
| Completed |
NCT04082585 -
Total Health Improvement Program Research Project
|
||
| Completed |
NCT05132998 -
Impact of a Comprehensive Cardiac Rehabilitation Program Framework Among High Cardiovascular Risk Cancer Survivors
|
N/A | |
| Completed |
NCT05067114 -
Solutions for Atrial Fibrillation Edvocacy (SAFE)
|
||
| Completed |
NCT04098172 -
Evaluate the Performance and Safety of Comet Pressure Guidewire in the Measurement of FFR
|
N/A |