The Effect of Colchicine, on Insulin Sensitivity in Individuals With Type 1 Diabetes and Systemic Low-grade Inflammation
NCT07247734 · Status: RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 26
Last updated 2025-12-23
Summary
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
- Type 1 Diabetes
- Chronic Inflammation
- Insulin Sensitivity
Interventions
- DRUG
-
Colchicin 0.5 mg once daily for two weeks, then twice daily for two weeks
Colchicine treatment in the first period
- DRUG
-
Placebo once daily for two weeks, then twice daily for two weeks
Placebo treatment in the first period
- DRUG
-
Colchicine tablet 0.5 mg once-daily for two weeks, then twice daily for two weeks
Colchicine treatment in the second period
- DRUG
-
Placebo once daily for two weeks, then twice daily for two weeks
Placebo treatment in the second period
Sponsors & Collaborators
-
University of Copenhagen
collaborator OTHER -
Asger Lund, MD
lead OTHER
Principal Investigators
-
Asger B Lund, MD, PhD · Center for Clinical Metabolic Research, Gentofte Hospital, Denmark
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- DOUBLE
- Model
- CROSSOVER
Eligibility
- Min Age
- 18 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2025-12-01
- Primary Completion
- 2026-12-22
- Completion
- 2027-06-22
Countries
- Denmark
Study Locations
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