Study on Colchicine for Reducing Inflammation in Patients with Type 1 Diabetes

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What is this study about?

This clinical trial is focused on studying the effects of a medication called colchicine in people with Type 1 diabetes. Type 1 diabetes is a condition where the body does not produce insulin, a hormone needed to control blood sugar levels. The trial aims to see if colchicine can help reduce inflammation in the body, which is often a concern for people with this type of diabetes. Participants in the study will either receive colchicine or a placebo, which looks like the medication but does not contain the active ingredient.

The purpose of the study is to determine how colchicine affects levels of a protein in the blood called high-sensitivity C-reactive protein, which is a marker of inflammation. The study will last for 26 weeks, during which participants will take the medication or placebo orally in the form of tablets. Throughout the study, various health indicators will be monitored, including blood sugar levels, insulin usage, body weight, and cholesterol levels, to understand the broader effects of colchicine on health.

By the end of the study, researchers hope to gather valuable information on whether colchicine can be an effective treatment for reducing inflammation in people with Type 1 diabetes. This could potentially lead to new ways of managing the condition and improving the quality of life for those affected. The study is designed to be thorough and will carefully monitor participants’ health to ensure safety and gather accurate results.

1 initial visit

Upon joining the study, you will attend an initial visit. During this visit, your eligibility will be confirmed based on specific criteria such as having type 1 diabetes for more than five years, being between 18 and 80 years old, and having stable insulin therapy.

Your medical history will be reviewed, and baseline measurements will be taken, including blood tests to measure C-reactive protein levels and other health indicators.

2 randomization

After the initial visit, you will be randomly assigned to one of two groups. One group will receive the medication colchicine, and the other group will receive a placebo (a tablet that looks like the medication but has no active ingredients).

This process is double-blind, meaning neither you nor the study team will know which group you are in.

3 medication administration

You will take the assigned tablet orally once a day for a duration of 26 weeks. It is important to take the tablet at the same time each day to maintain consistency.

You will be provided with instructions on how to take the medication and what to do if you miss a dose.

4 follow-up visits

Throughout the 26-week period, you will have regular follow-up visits. These visits will include health assessments and blood tests to monitor your C-reactive protein levels and other health markers.

You will also be asked about any side effects or changes in your health.

5 final assessment

At the end of the 26 weeks, you will have a final assessment. This will include a comprehensive review of your health, including blood tests and other measurements.

The study team will discuss the results with you and provide any necessary follow-up care or instructions.

Who Can Join the Study?

Have been diagnosed with Type 1 diabetes for more than five years.
Be between the ages of 18 and 80 years old.
Have an HbA1c level of less than 80 mmol/mol. HbA1c is a measure of your average blood sugar levels over the past 2 to 3 months.
Be on stable insulin therapy, meaning no recent changes in insulin brand or starting new insulin delivery methods like pumps or multiple daily injections, for at least 3 months. If using glucose monitoring technology, it should also be stable for at least 3 months.
Have a C-reactive protein level of 2 mg/l or higher. This is a blood test that measures inflammation in the body.
Have an estimated glomerular filtration rate greater than 50 ml/min/1.73 m². This is a test to check how well your kidneys are working.
Have either stable atherosclerotic cardiovascular disease or be at high risk for it. This includes conditions like heart disease, previous heart attacks, strokes, or other related conditions. High risk is defined by specific medical guidelines or a 10-year cardiovascular risk of 20% or more.

Who Cannot Join the Study?

Patients with Type 1 diabetes cannot participate.

Where you can join this trial?

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Verified Sites

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Other Sites

Site Name	City	Country
Gentofte Hospital	Hellerup	Denmark
Steno Diabetes Center Copenhagen	Herlev	Denmark
Hkqhcykd Hzfpmmoc	Hillerød	Denmark

Trial status

Country	Status	Recruitment Start
Denmark	Not recruiting	01.04.2023

Trial locations

Investigated drugs:

Colchicine

Colchicine is a medication that is being studied for its potential to reduce inflammation in people with type 1 diabetes. In this trial, researchers are looking at how colchicine affects the levels of a specific protein in the blood called high-sensitivity C-reactive protein (hs-CRP). This protein is a marker of inflammation, and by lowering its levels, colchicine might help reduce the risk of complications related to inflammation in diabetes. The study aims to see if colchicine can effectively lower these protein levels over a period of 26 weeks.

Investigated diseases:

Type 1 diabetes mellitus

Type 1 diabetes – Type 1 diabetes is a chronic condition where the pancreas produces little or no insulin, a hormone needed to allow sugar (glucose) to enter cells to produce energy. The disease typically begins in childhood or young adulthood, but it can develop at any age. It progresses as the immune system mistakenly attacks and destroys insulin-producing beta cells in the pancreas. As a result, blood sugar levels become elevated, leading to symptoms such as increased thirst, frequent urination, hunger, fatigue, and blurred vision. Over time, if not managed, it can lead to complications affecting the heart, blood vessels, nerves, eyes, and kidneys. The progression of the disease requires ongoing monitoring and management of blood sugar levels.

Trial ID:

2022-502038-23-00

Protocol code:

The REC1TE trial

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on Colchicine for Reducing Inflammation in Patients with Type 1 Diabetes

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