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

ConditionsType 1 Diabetes Chronic Inflammation Insulin Sensitivity

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

This trial does not accept healthy volunteers

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

Design model

Crossover

Treatments tested in this trial

Colchicin 0.5 mg once daily for two weeks, then twice daily for two weeks
Drug
Colchicine treatment in the first period
Placebo once daily for two weeks, then twice daily for two weeks
Drug
Placebo treatment in the first period
Colchicine tablet 0.5 mg once-daily for two weeks, then twice daily for two weeks
Drug
Colchicine treatment in the second period
Placebo once daily for two weeks, then twice daily for two weeks
Drug
Placebo treatment in the second period

Treatment groups

26 Participants

are divided into 2 treatment groups

Group A: Colchicine first period, placebo second periodActive comparator 2 interventions

Group B: Placebo first period, colchicine second periodActive comparator 2 interventions

Trial outcomes

Primary outcomes

Mean difference in M-value

Mean difference in insulin sensitivity is measured by the M-value (glucose infusion rate mg/kg/min) during the last 30 minutes of a 180 minutes hyperinsulinemic euglycemic clamp procedure using insulin infusion rate of 60 mU/m²/min

Time frame

Four weeks of treatment comparing colchicine to placebo.

Secondary outcomes

Mean difference in M-value

Measured in mg/m²/min. Adjusted to body surface area (BSA)

Time frame

After four weeks of placebo/colchicine

Mean difference in M-value (adjusted to fat free mass (FFM))

Measured in mg/kg FFM/min

Time frame

After four weeks of placebo/colchicine

Mean difference in Insulin Sensitivity Index (ISI)

Glucose infusion rate / Plasma insulin in steady state

Time frame

After four weeks of placebo/colchicine

Mean difference in average daily insulin dosage

Units/day. Total daily dose, short acting, long acting

Time frame

During four weeks of placebo/colchicine

Other outcomes

Mean difference in respiratory exchange ratio between basal state and during clamp

Ratio

Time frame

After four weeks of placebo/colchicine

Adipocyte tissue biopsies

Ratio. Fold difference in Adipocyte size, Inflammation, Glucose metabolism, Extracellular matrix, Oxygen consumption, Transcriptomics, Proteomics

Time frame

After four weeks of placebo/colchicine

Time spent in target blood glucose range (3.9 - 10 mmol/L) evaluated by a continous glucose monitor (CGM)

Measured in % of 24 hours.

Time frame

The last 7 days of each treatment period.

Time spent in tight range (3.9 - 7.8 mmol/L) evaluated by a continous glucose monitor (CGM)

Measured in % of 24 hours.

Time frame

The last 7 days of each treatment period.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Asger Lund, MD

Lead sponsor

University Hospital, Gentofte, Copenhagen

Sponsor institution

University of Copenhagen

Collaborator

Source ClinicalTrials.gov

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