Study of Colchicine to Reduce Complications in People with Type 1 Diabetes and High Blood Sugar Variability

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What is this study about?

This clinical trial focuses on people with Type 1 Diabetes who experience high blood sugar variability. The study aims to investigate whether colchicine, an anti-inflammatory medication, can help prevent or reduce complications that affect small blood vessels in diabetes, particularly those affecting the eyes (diabetic retinopathy) and kidneys (diabetic nephropathy).

The study will use Colchicine Teva tablets that are modified into capsules containing 0.5 milligrams of the active medication. These capsules also contain microcrystalline cellulose, an inactive substance. Some participants will receive the active medication, while others will receive capsules containing only microcrystalline cellulose (placebo).

The treatment period will last 18 weeks, during which participants will take their assigned medication while continuing their regular diabetes care. Throughout the study, various measurements will be taken to monitor changes in the blood vessels of the eyes and to check kidney function through blood and urine tests. The study will also track how blood sugar levels change over time using continuous glucose monitoring devices worn by participants.

1 Initial assessment

Your eligibility for the study will be evaluated based on specific criteria, including having type 1 diabetes for at least 5 years, being between 18-65 years old, and using a continuous glucose monitor for at least 3 months

Your eye measurements will be checked to ensure your vision prescription is within the required range

2 Treatment period start

You will receive either colchicine tablets (0.5 mg) or placebo tablets for oral use

The treatment period begins in September 2025

3 Regular monitoring

Your blood sugar patterns will be tracked through your continuous glucose monitor

Regular eye examinations will be conducted to measure changes in your blood vessels

Blood and urine tests will be performed to check kidney function

Blood samples will be taken to measure inflammation markers

4 Study completion

The study continues until March 2027

Final assessments will include eye examinations, blood tests, and urine analysis to measure the effects of the treatment

Who Can Join the Study?

You must have been diagnosed with Type 1 diabetes for at least 5 years
Your age must be between 18 and 65 years
Your HbA1c (a blood test that measures average blood sugar levels over the past 2-3 months) must be equal to or lower than 100 mmol/mol
You must have high glycemic variability (your blood sugar levels change significantly throughout the day) with at least 30% variation
You must have been using a continuous glucose monitor (a device that tracks your blood sugar levels throughout the day) for at least 3 months before starting the study
Your vision prescription must be between -6 and +6 diopters (this refers to how strong your glasses or contact lens prescription needs to be)
Both men and women can participate in this study

Who Cannot Join the Study?

Current age below 18 or above 65 years
Pregnant women or women planning pregnancy during the study
Breastfeeding women
History of allergic reactions to colchicine or similar medications
Severe kidney problems (as measured by creatinine clearance below 30 mL/min)
Severe liver disease
Active infections
History of heart problems or current heart conditions
Current participation in other clinical trials
Use of medications that may interact with colchicine
Inability to follow study procedures or attend scheduled visits
History of gastrointestinal disorders (serious problems with stomach or intestines)
Blood disorders or current abnormal blood cell counts
Uncontrolled blood pressure (higher than 160/100 mmHg)
History of cancer in the past 5 years

Where you can join this trial?

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Verified Sites

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Other Sites

Site Name	City	Country	Status
Stichting Radboud University Medical Center	Nijmegen	The Netherlands

Trial status

Country	Status	Recruitment Start
The Netherlands	Recruiting	01.09.2025

Trial locations

Investigated drugs:

Colchicine

Colchicine is a medication that has been traditionally used to treat gout and other inflammatory conditions. In this trial, it is being studied for a new purpose – to help people with type 1 diabetes who experience frequent changes in their blood sugar levels. The medication works by reducing inflammation in blood vessels, which may help prevent complications that affect small blood vessels in the eyes and kidneys of people with diabetes.

Investigated diseases:

Type 1 diabetes mellitus

Type 1 Diabetes – A chronic condition where the body’s immune system attacks and destroys insulin-producing cells in the pancreas. This leads to the body being unable to produce insulin, which is necessary for controlling blood sugar levels. Over time, high blood sugar can affect small blood vessels throughout the body, particularly in the eyes (diabetic retinopathy) and kidneys (diabetic nephropathy). The condition typically develops in childhood or adolescence but can occur at any age. People with Type 1 diabetes experience fluctuations in their blood glucose levels, known as glycemic variability.

Diabetic Retinopathy – A complication affecting the blood vessels in the retina of the eye that occurs in people with diabetes. The condition develops gradually as high blood sugar levels damage the tiny blood vessels that supply the retina. These vessels may swell, leak, or close off, and in some cases, abnormal new blood vessels grow on the surface of the retina. Early stages may not cause noticeable vision changes, but the condition can progress over time.

Diabetic Nephropathy – A kidney condition that develops in some people with diabetes. It occurs when high blood sugar levels damage blood vessels in the kidneys over time. The damaged vessels become less efficient at filtering waste from the blood. The condition typically develops slowly, beginning with small amounts of protein leaking into the urine.

Trial ID:

2025-521397-34-00

Protocol code:

116795

Trial Phase:

Human Pharmacology (Phase I) – Other

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Study of Colchicine to Reduce Complications in People with Type 1 Diabetes and High Blood Sugar Variability

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?