RecruitingPhase 2NCT07247734

The Effect of Colchicine, on Insulin Sensitivity in Individuals With Type 1 Diabetes and Systemic Low-grade Inflammation

The Effect of Colchicine, on Insulin Sensitivity in Individuals With Type 1 Diabetes and Systemic Low-grade Inflammation: A Randomized, Double-Blind, Placebo-Controlled, Investigator-Initiated Trial


Sponsor

Asger Lund, MD

Enrollment

26 participants

Start Date

Dec 1, 2025

Study Type

INTERVENTIONAL

Conditions

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.


Eligibility

Min Age: 18 YearsMax Age: 80 Years

Plain Language Summary

Simplified for easier understanding

This study tests whether colchicine (an anti-inflammatory drug commonly used for gout) can improve insulin sensitivity in people with type 1 diabetes who also have elevated markers of low-grade systemic inflammation. Inflammation may worsen insulin resistance in type 1 diabetes, and colchicine may help reduce it. **You may be eligible if...** - You are 18 to 80 years old with type 1 diabetes (diagnosed for more than 5 years) - Your HbA1c (a measure of long-term blood sugar control) is between 42–75 mmol/mol - You use a continuous glucose monitor (CGM) - Your insulin therapy has been stable (no major changes recently) - You have elevated markers of systemic inflammation (CRP or IL-6 above specific thresholds) **You may NOT be eligible if...** - You have significant kidney or liver disease - You are pregnant or planning to become pregnant - You have a known allergy or intolerance to colchicine - You have had recent major changes to your insulin regimen Talk to your doctor to see if this trial is right for you.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

Interested in this trial?

Get notified about updates and connect with the research team.

Interventions

DRUGColchicin 0.5 mg once daily for two weeks, then twice daily for two weeks

Colchicine treatment in the first period

DRUGPlacebo once daily for two weeks, then twice daily for two weeks

Placebo treatment in the first period

DRUGColchicine tablet 0.5 mg once-daily for two weeks, then twice daily for two weeks

Colchicine treatment in the second period

DRUGPlacebo once daily for two weeks, then twice daily for two weeks

Placebo treatment in the second period


Locations(1)

Center for Clinical Metabolic Research, Gentofte Hospital, Hellerup, Capital Region 2900

Gentofte Municipality, Denmark

View Full Details on ClinicalTrials.gov

For the most up-to-date information, visit the official listing.

Visit

NCT07247734


Related Trials