Study on Hyperpolarized [1-13C]Pyruvate and Meglumine Gadoterate for Patients with Diabetic Kidney Disease

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What is this study about?

This clinical trial is focused on studying Diabetic Kidney Disease, a condition that affects the kidneys of people with diabetes. The study will use a special type of imaging called hyperpolarized [1-13C]pyruvate MRI to look at how the kidneys are working. This imaging technique involves using a substance called pyruvic acid, which is injected into the body to help create clearer images of the kidneys. The study will also use another substance called meglumine gadoterate, which is commonly used in MRI scans to improve the quality of the images.

The purpose of the study is to see if this imaging method can help classify the progression of diabetic kidney disease. Participants in the study will receive injections of these substances and undergo MRI scans to assess kidney function. The study will look at how well the kidneys are working by measuring things like metabolism and blood flow in the kidneys. The study will also check how reliable the imaging method is by repeating the scans to see if the results are consistent.

Throughout the study, participants will be monitored to ensure their safety and to gather information on how their kidneys are functioning. The study aims to provide new insights into diabetic kidney disease and potentially improve how this condition is diagnosed and monitored in the future.

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 age and kidney function.

You will be asked to provide a urine sample to measure the albumin-creatinine ratio, which helps assess kidney health.

2 preparation for imaging

Before the imaging procedure, you will receive an intravenous infusion of Hyperpolarized [1-13C]pyruvate. This is a special form of pyruvic acid that helps in visualizing kidney function during the scan.

The infusion is administered through a vein in your arm and is designed to enhance the imaging process.

3 imaging procedure

You will undergo a magnetic resonance imaging (MRI) scan. This scan uses the infused Hyperpolarized [1-13C]pyruvate to capture detailed images of your kidneys.

The procedure is non-invasive and aims to assess the metabolism and blood flow in your kidneys.

4 follow-up visits

After the imaging procedure, you will have follow-up visits to monitor your health and gather additional data.

These visits may include further urine tests and assessments of kidney function to track any changes over time.

5 completion of trial

The trial is expected to continue until August 2029. Your participation will contribute to understanding diabetic kidney disease better.

Upon completion, you will receive information about the study’s findings and any relevant health insights.

Who Can Join the Study?

Participants must be between 18 and 85 years old.
Pre-menopausal women must be confirmed as not pregnant.
For those with Type 1 Diabetes Mellitus and diabetic kidney disease:
- Must have an eGFR (a test that measures kidney function) greater than 15 ml/min but less than or equal to 60 ml/min.
- Must have a urine albumin-creatinine ratio greater than 100 mg/g (a test that checks for protein in the urine).
For those with Type 1 Diabetes Mellitus but without diabetic kidney disease:
- Must have an eGFR greater than 60 ml/min.
- Must not have albuminuria (urine albumin-creatinine ratio less than 30 mg/g).
- Must not have signs of proliferative retinopathy or macular edema (eye conditions related to diabetes).
Control subjects (those without diabetes) must have an eGFR greater than 60 ml/min.

Who Cannot Join the Study?

Patients with any other serious health conditions that could affect the study results.
Patients who are pregnant or breastfeeding.
Patients who have participated in another clinical trial within the last 30 days.
Patients with a history of allergic reactions to the substances used in the study.
Patients who are unable to undergo an MRI scan. An MRI is a type of scan that uses strong magnets and radio waves to create detailed images of the inside of the body.
Patients with severe claustrophobia. Claustrophobia is a fear of being in small or enclosed spaces.
Patients with metal implants that are not compatible with MRI machines.
Patients who are unable to give informed consent. Informed consent means understanding the details of the study and agreeing to participate.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Acogac Uqhdsxmime Hqrigbpf	Aarhus	Denmark

Trial status

Country	Status	Recruitment Start
Denmark	Not recruiting	01.01.2024

Trial locations

Investigated drugs:

Hyperpolarized [1-13C]Pyruvate is a special form of a naturally occurring substance called pyruvate, which is involved in energy production in the body. In this clinical trial, it is used in a special imaging technique called MRI to help doctors see how well the kidneys are working in people with diabetic kidney disease. This technique allows doctors to get a clearer picture of the kidney’s function and metabolism, which can help in understanding the progression of the disease.

Diabetic Kidney Disease – Diabetic Kidney Disease is a condition that affects the kidneys due to long-term diabetes. It is characterized by damage to the small blood vessels in the kidneys, which impairs their ability to filter waste from the blood. Over time, this damage can lead to the leakage of protein into the urine, a condition known as proteinuria. As the disease progresses, the kidneys’ filtering capacity continues to decline, leading to a buildup of waste products in the body. This can result in symptoms such as swelling in the legs and feet, fatigue, and high blood pressure. The progression of the disease can vary, but it generally leads to a gradual decline in kidney function.

Trial ID:

2023-508824-36-00

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on Hyperpolarized [1-13C]Pyruvate and Meglumine Gadoterate for Patients with Diabetic Kidney Disease

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?