The Effect of Colchicine, on Insulin Sensitivity in Individuals With Type 1 Diabetes and Systemic Low-grade Inflammation
Trial statusRecruiting
Trial phasePhase 2
Trial typeInterventional
Biological sexAll
Age18-80
SponsorAsger Lund, MD
About this trial
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.
Eligibility criteria
Qualifiers
Type 1 diabetes for more than five years according to World Health Organization criteria and c-peptid <200 pmol/L
Age 18-80 years
User of a continuous glucose monitor (CGM) system
Glycated hemoglobin A1c (HbA1c) 42-75 mmol/mol
Disqualifiers
Hypoglycaemia unawareness (inability to register low blood glucose) ad modum Pedersen-Bjergaard, 24 unless the individual uses a continuous glucose monitor with alarm function
Liver disease with elevated plasma alanine aminotransferase (ALT) > three times the upper limit of normal (measured at screening visit 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 diarrhoea
Trial design
Treatments tested in this trial
- Colchicin 0.5 mg once daily for two weeks, then twice daily for two weeks
- Placebo once daily for two weeks, then twice daily for two weeks
- Colchicine tablet 0.5 mg once-daily for two weeks, then twice daily for two weeks
- Placebo once daily for two weeks, then twice daily for two weeks
Treatment groups
26 Participants
are divided into 2 treatment groupsSponsors and collaborators
Asger Lund, MD
Lead sponsor
University Hospital, Gentofte, Copenhagen
Sponsor institution
University of Copenhagen
Collaborator
Source ClinicalTrials.gov