Study on How Metformin Affects Arterial Calcification in Patients with Type 1 Diabetes Without Chronic Kidney Disease

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What is this study about?

This clinical trial is focused on studying the effects of the medication metformin on a condition known as peripheral arterial calcification in individuals with Type 1 Diabetes. Peripheral arterial calcification is a condition where calcium builds up in the walls of the arteries, which can affect blood flow. The purpose of the study is to determine if metformin can slow down this calcification process in patients with Type 1 Diabetes who do not have chronic kidney disease.

Participants in the study will be divided into two groups. One group will receive the medication metformin, while the other group will receive a placebo, which looks like the medication but does not contain the active ingredient. The study will last for two years, during which time participants will undergo various assessments to measure changes in their arterial calcification. These assessments will include imaging tests like CT scans to evaluate the calcification in the arteries below the knee.

The study aims to compare the differences in calcification between the two groups over the two-year period. Additionally, other measurements such as the ankle and toe brachial indexes and pulse wave velocity will be taken to provide further insights into the effects of metformin on vascular health in Type 1 Diabetes patients. The results of this study could help in understanding how metformin might benefit individuals with this condition.

1 enrollment

Upon joining the study, eligibility is confirmed based on criteria such as having type 1 diabetes and being between 18 and 80 years old.

Informed consent is required, and for women of childbearing age, effective contraception must be used throughout the trial.

2 initial assessment

An initial assessment is conducted, including a CT-scan to evaluate below-knee arterial calcification.

Other assessments may include ultrasonographic occlusion scores, ankle and toe brachial indexes, and pulse wave velocity measurements.

3 medication administration

Participants are randomly assigned to receive either metformin hydrochloride or a placebo.

The medication is administered orally in the form of a 1000 mg film-coated tablet.

4 ongoing monitoring

Regular monitoring occurs throughout the trial to track any changes in arterial calcification and other health indicators.

Participants continue to take the assigned medication as directed.

5 final assessment

At the end of the trial period, a final assessment is conducted, including a repeat CT-scan to measure changes in below-knee arterial calcification.

Other measurements taken at the start of the trial are repeated to assess any differences.

Who Can Join the Study?

Have Type 1 diabetes.
Be a woman or man aged between 18 and 80 years old.
Have one or more of the following complications:
- Diabetic retinopathy: Eye problems caused by diabetes.
- Nephropathy with creatinine clearance of at least 60 mL/min: Kidney problems, but the kidneys are still working well enough.
- Neuropathy: Nerve damage caused by diabetes.
- Peripheral arterial occlusive disease: Narrowing of blood vessels in the legs.
- Cardiopathy: Heart problems.
- Stroke: A condition where blood flow to the brain is interrupted.
Have one or more of the following cardiovascular risk factors:
- Hypertension: High blood pressure.
- Dyslipidemia: Abnormal levels of fats in the blood, such as low HDL (good cholesterol) or high LDL (bad cholesterol), or being treated for this condition.
- Tobacco use: Either currently smoking or having smoked more than 5 pack years (a way to measure smoking history).
Have had diabetes for more than 20 years.
For women who can have children, use effective birth control during the entire trial.
Provide signed written informed consent, which means agreeing to participate after understanding the study details.
Be affiliated with a social security regime (patients with AME cannot participate).

Who Cannot Join the Study?

Patients with chronic kidney disease cannot participate. This means if your kidneys are not working well over a long period, you cannot join.
Patients who do not have type 1 diabetes are excluded. Type 1 diabetes is a condition where the body does not produce insulin, a hormone needed to control blood sugar levels.
Patients who do not have vascular calcification are excluded. Vascular calcification is when calcium builds up in the blood vessels, making them hard.
Patients who are not within the specified age range cannot participate. The study is for certain age groups only.
Patients who are part of a vulnerable population are excluded. This means people who might need special protection or care, like children or those unable to make decisions for themselves, cannot join.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Hopital Beaujon	Clichy	France

Trial status

Country	Status	Recruitment Start
France	Recruiting	02.06.2021

Trial locations

Investigated drugs:

Metformin Hydrochloride

Metformin is a medication commonly used to manage blood sugar levels in people with diabetes. In this clinical trial, it is being studied to see if it can slow down the calcification of arteries below the knee in patients with type 1 diabetes who do not have chronic kidney disease. The goal is to determine if metformin can help reduce the risk of complications related to arterial calcification in these patients.

Investigated diseases:

Vascular calcification

Vascular Calcification – Vascular calcification is a condition where calcium builds up in the blood vessels, leading to hardening and loss of elasticity. This process can occur in various parts of the body, including arteries below the knee. Over time, the calcification can progress, potentially affecting blood flow and increasing the risk of complications. It is often associated with other conditions such as diabetes and can be influenced by factors like age and diet. The progression of vascular calcification can vary, with some individuals experiencing more rapid changes than others.

Type 1 Diabetes – Type 1 diabetes is a chronic condition where the pancreas produces little or no insulin, a hormone necessary for glucose to enter cells and produce energy. It typically appears in childhood or adolescence but can develop in adults. The disease progresses as the immune system mistakenly attacks insulin-producing cells in the pancreas. Without insulin, blood sugar levels rise, leading to various health issues over time. Management of blood sugar levels is crucial to prevent complications associated with the disease.

Trial ID:

2024-511867-27-00

Protocol code:

D20180102

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on How Metformin Affects Arterial Calcification in Patients with Type 1 Diabetes Without Chronic Kidney Disease

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?