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

Verified siteRegistered drugNo placebo
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What is this trial about?

A plain-language summary of the goals, design and what participants do

This clinical trial is focused on studying insulin resistance in individuals who have undergone a kidney transplant or have chronic kidney disease. The trial will explore the effects of a medication called Pravastatin, which is commonly used to lower cholesterol levels, on the body's ability to use insulin effectively. Insulin is a hormone that helps control blood sugar levels, and resistance to it can lead to higher blood sugar levels, which is a concern for people with kidney issues.

The purpose of the study is to assess how Pravastatin affects insulin sensitivity compared to a placebo. Participants in the study will receive either Pravastatin or a placebo. The study will involve taking the medication in the form of tablets over a period of time. The effects on insulin sensitivity will be monitored using a method called the hyperinsulinemic euglycemic glucose clamp, which is a way to measure how well the body responds to insulin.

In addition to Pravastatin, the study will also involve the use of other substances such as glucose, potassium chloride, and insulin (human), which will be administered intravenously. These substances are used to help understand the body's response to insulin and to maintain necessary body functions during the study. The trial aims to provide insights into how Pravastatin might help improve insulin sensitivity in people with kidney-related health issues.

The research process

The trial runs in 5 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Initial assessment

    Upon joining the study, an initial assessment will be conducted to confirm eligibility. This includes verifying age, body mass index (BMI), and kidney function.

    Participants must have had a renal transplant more than six months ago or have chronic kidney disease at stage 3.

  2. Step 2

    Consent and information

    Participants will be provided with detailed information about the study and asked to give written, informed consent to participate.

  3. Step 3

    Medication administration

    Participants will be randomly assigned to receive either Pravastatin or a placebo. Pravastatin is administered orally in the form of a 40 mg tablet.

    The medication will be taken once daily for the duration of the study.

  4. Step 4

    Regular monitoring

    Participants will undergo regular monitoring to assess insulin sensitivity. This will be done using a method called the hyperinsulinemic euglycemic glucose clamp, which measures how the body responds to insulin.

    Additional health checks and assessments may be conducted as needed to ensure participant safety.

  5. Step 5

    Completion of study

    The study is expected to conclude by November 1, 2024. Participants will be informed of the study's findings and any relevant health information.

Who can join the trial?

7 criteria

  • Age between 40 and 70 years old.
  • Body Mass Index (BMI) between 20 and 30 kg/m2. BMI is a measure of body fat based on height and weight.
  • For Study 1: Must have had a kidney transplant more than 6 months ago.
  • For Study 1: Must be on a combination of medications that suppress the immune system, including mycophenolate, tacrolimus, and prednisolone.
  • For Study 2: Must have chronic kidney disease at stage 3. This means the kidneys are moderately damaged, with an estimated glomerular filtration rate (eGFR) between 30 and 59 ml/min. eGFR is a test that measures how well the kidneys are working.
  • For both studies: Must have an eGFR greater than 29 ml/min.
  • Must provide written, informed consent before joining the study. This means you agree to participate after understanding the study details.

Who cannot join the trial?

9 criteria

  • Patients with any serious heart conditions cannot participate.
  • Patients who are pregnant or breastfeeding are not eligible.
  • Individuals with severe liver disease are excluded.
  • Patients currently taking medications that affect **insulin sensitivity** cannot join. Insulin sensitivity refers to how responsive your body is to the effects of insulin, a hormone that helps control blood sugar levels.
  • Anyone with a history of allergic reactions to **Pravastatin** or similar drugs is not allowed. Pravastatin is a medication used to lower cholesterol.
  • Participants in another clinical trial are not eligible.
  • Individuals with uncontrolled high blood pressure are excluded.
  • Patients with a history of drug or alcohol abuse cannot participate.
  • Anyone with a mental health condition that affects their ability to understand the study or follow instructions is not eligible.
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Investigated drugs

Pravastatin is a medication used to lower cholesterol levels in the blood. It belongs to a group of drugs called statins, which work by reducing the amount of cholesterol made by the liver. In this clinical trial, Pravastatin is being studied to see how it affects insulin sensitivity in people who have had a kidney transplant or have chronic kidney disease. The goal is to understand if Pravastatin can help improve how the body uses insulin, which is important for managing blood sugar levels.

What is already known about the treatment

Pravastatin – Pravastatin is a medication taken orally, usually in the form of a tablet, and is used to help improve insulin sensitivity in patients. It is currently being studied in clinical trials to understand its effects on insulin resistance, particularly in individuals who have undergone kidney transplants or have chronic kidney disease. The main therapeutic use of Pravastatin is to lower cholesterol levels, but it is also being explored for its potential benefits in managing insulin resistance. At the molecular level, Pravastatin works by inhibiting an enzyme in the liver that is responsible for producing cholesterol, which can also have an impact on insulin sensitivity. It belongs to a class of drugs known as statins, which are commonly used to manage high cholesterol and reduce the risk of heart disease.

Investigated diseases

Insulin Resistance – Insulin resistance is a condition where the body's cells do not respond effectively to the hormone insulin. Insulin is crucial for helping glucose enter cells to be used for energy. When cells become resistant, the pancreas produces more insulin to help glucose enter cells. Over time, this can lead to higher blood sugar levels. The condition often progresses gradually and can be associated with other metabolic disorders. It is commonly linked to obesity, physical inactivity, and genetic factors.
Trial detailsLast updated 2 Oct 2026
Age18+ yearsPhasePhase IITrial ID2022-501068-16-00Protocol codeINSTAEstimated enrolment30 patientsSponsorRegion Midtjylland

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