Insulin resistance Trials in Disease

Study on Pravastatin's Effect on Insulin Resistance in Kidney Transplant and Chronic Kidney Disease Patients

This clinical trial is investigating how Pravastatin, a medication typically used to lower cholesterol, affects the body's ability to use insulin effectively. The study focuses on two groups of patients: those who have received a kidney transplant and those living with chronic kidney disease at stage 3.

Main inclusion criteria:

• Adults between 40 and 70 years old
• Body Mass Index (BMI) between 20 and 30 kg/m²
• For kidney transplant recipients: transplant must have occurred more than 6 months ago, and patients must be taking a specific combination of immune-suppressing medications (mycophenolate, tacrolimus, and prednisolone)
• For chronic kidney disease patients: kidney function must be at stage 3, with an estimated glomerular filtration rate (eGFR) between 30 and 59 ml/min
• All participants must have an eGFR greater than 29 ml/min
• Written, informed consent is required

Main exclusion criteria:

• Serious heart conditions
• Pregnancy or breastfeeding
• Severe liver disease
• Current use of medications that affect insulin sensitivity
• History of allergic reactions to Pravastatin or similar drugs
• Participation in another clinical trial
• Uncontrolled high blood pressure
• History of drug or alcohol abuse
• Mental health conditions that affect the ability to understand the study or follow instructions

Study focus and goal:

The trial aims to understand whether Pravastatin can improve insulin sensitivity in people with kidney-related health issues. Insulin is a hormone that helps control blood sugar levels, and when the body becomes resistant to it, blood sugar levels can rise, which is particularly concerning for people with kidney problems. Participants will be randomly assigned to receive either Pravastatin (40 mg tablet taken once daily) or a placebo. The study will monitor how well the body responds to insulin using a specialized measurement method called the hyperinsulinemic euglycemic glucose clamp. This process involves administering glucose, potassium chloride, and insulin intravenously to accurately assess the body's insulin response.

Investigational drug:

The medication being tested is Pravastatin, which belongs to a class of drugs called statins. While statins are primarily known for lowering cholesterol by reducing the amount of cholesterol produced by the liver, this study is exploring whether Pravastatin can also help improve how the body uses insulin. The trial is investigating this potential additional benefit specifically in patients who have undergone kidney transplants or have chronic kidney disease.