Vascular calcification Trials in Disease

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

This clinical trial is investigating whether metformin, a medication commonly used to manage blood sugar levels, can slow down the buildup of calcium in the arteries of patients with type 1 diabetes. The condition being studied is peripheral arterial calcification, where calcium deposits accumulate in the walls of blood vessels, potentially affecting blood flow and increasing the risk of complications.

Main inclusion criteria:

• Have type 1 diabetes for more than 20 years
• Be between 18 and 80 years old
• Have at least one diabetes-related complication, such as eye problems (retinopathy), kidney problems with adequate function, nerve damage (neuropathy), narrowed blood vessels in the legs, heart problems, or have had a stroke
• Have at least one cardiovascular risk factor, including high blood pressure, abnormal cholesterol levels, or a history of tobacco use
• Women of childbearing age must use effective birth control throughout the trial
• Be affiliated with a social security system

Main exclusion criteria:

• Having chronic kidney disease with poor kidney function over a long period
• Not having type 1 diabetes
• Not having vascular calcification
• Being outside the specified age range
• Belonging to a vulnerable population that requires special protection, such as children or those unable to make decisions independently

Focus and goal of the trial:

The study will last for two years and participants will be randomly divided into two groups. One group will receive metformin hydrochloride in the form of 1000 mg tablets, while the other group will receive a placebo that looks identical but contains no active medication. Throughout the trial, participants will undergo various assessments to measure changes in arterial calcification. These assessments include CT scans of the arteries below the knee, measurements of blood flow in the ankles and toes, and pulse wave velocity tests to evaluate vascular health. The primary aim is to compare the differences in calcium buildup between the two groups over the two-year period and determine if metformin can provide protective benefits for the blood vessels.

Investigational drug:

The medication being tested is metformin, which belongs to a class of drugs called biguanides. While metformin is well-established as a treatment for type 2 diabetes, this trial explores whether it can also help patients with type 1 diabetes by slowing arterial calcification. Metformin works by reducing glucose production in the liver and improving how the body responds to insulin, which helps control blood sugar levels. In this study, researchers are investigating whether these effects might also slow down the process of calcium accumulation in blood vessel walls.

Summary

Currently, only one clinical trial is actively investigating treatments for vascular calcification. This trial is being conducted in France and focuses specifically on patients with type 1 diabetes who have had the condition for more than 20 years and who do not have chronic kidney disease. The research examines metformin, a well-known diabetes medication, to see if it can offer additional benefits beyond blood sugar control by slowing the progression of arterial calcification. The trial uses a placebo-controlled design over a two-year period with detailed imaging assessments to measure changes in calcium buildup in the arteries below the knee. This research represents an important step in understanding whether existing medications might be repurposed to address vascular complications in patients with long-standing type 1 diabetes.