Actively Recruiting
The Effect of Colchicine, on Insulin Sensitivity in Individuals With Type 1 Diabetes and Systemic Low-grade Inflammation
Led by Asger Lund, MD · Updated on 2025-12-23
26
Participants Needed
1
Research Sites
81 weeks
Total Duration
On this page
Sponsors
A
Asger Lund, MD
Lead Sponsor
U
University of Copenhagen
Collaborating Sponsor
AI-Summary
What this Trial Is About
The aim for this clinical trial is to evaluate if colchicine in addition to standard of care improves insulin sensitivity in individuals with type 1 diabetes, systemic low-grade inflammaiton and reduced insulin sensitivity. The insulin sensitivity will be evaluated by a hyperinsulinemic, euglycemic clamp.
CONDITIONS
Official Title
The Effect of Colchicine, on Insulin Sensitivity in Individuals With Type 1 Diabetes and Systemic Low-grade Inflammation
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Type 1 diabetes for more than five years according to World Health Organization criteria and c-peptid <200 pmol/L
- Age 18 to 80 years
- User of a continuous glucose monitor (CGM) system
- Glycated hemoglobin A1c (HbA1c) between 42 and 75 mmol/mol
- Stable insulin therapy (no change in insulin brand and no new continuous subcutaneous insulin infusion or multiple daily injection therapy) and stable use of glucose monitoring technology for at least 3 months
- Estimated glomerular filtration rate ≥ 60 mL/min/1.73 m²
- Estimated glucose disposal rate (eGDR) < 8 mg/kg/min OR insulin use of ≥1 IU/kg per day
- C-reactive protein (hsCRP) ≥ 2 mg/L (measured by high-sensitivity assay)
You will not qualify if you...
- Hypoglycaemia unawareness unless using a continuous glucose monitor with alarm function
- Liver disease with plasma alanine aminotransferase (ALT) > three times the upper limit of normal
- History of cirrhosis, chronic active hepatitis, or severe liver disease
- Inflammatory bowel disease or chronic diarrhoea
- Progressive neuromuscular disease or creatinine kinase levels > three times the upper limit of normal
- Cancer or lymphoproliferative disease unless in complete remission for more than 5 years
- Blood disorders such as myelodysplastic syndromes
- Leukocyte cell count < 3.0 x 10⁹/L
- Thrombocyte count < 110 x 10⁹/L
- Immunosuppressive therapy or chronic immunodeficiency including HIV infection
- Treatment with anti-inflammatory drugs or systemic steroids during the study or within four weeks before start (inhaled steroids allowed)
- Treatment with colchicine within 60 days before screening
- Known or suspected allergy to colchicine
- Treatment with glucose-lowering drugs other than insulin during the study or within four weeks before start
- Receiving haemodialysis or peritoneal dialysis
- Treatment with certain medications like P-glycoprotein or strong CYP3A4 inhibitors
- Intake of grapefruit juice
- Other diseases or treatments making participation unsuitable
- Alcohol or drug abuse
- For women of childbearing potential, must use effective contraception and not be pregnant or breastfeeding
- Participants unable to speak or understand Danish
- Receipt of investigational drugs within 30 days before first visit
- Participation in another clinical intervention trial simultaneously
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Center for Clinical Metabolic Research, Gentofte Hospital, Hellerup, Capital Region 2900
Gentofte Municipality, Denmark, 2400
Actively Recruiting
Research Team
A
Askee N. Høck, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
CROSSOVER
Primary Purpose
TREATMENT
Number of Arms
2
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