Study on Dulaglutide for Preventing Diabetes in New Kidney Transplant Patients

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What is this study about?

This clinical trial is focused on studying the prevention of a condition known as post-kidney transplant diabetes, which can occur after a person receives a kidney transplant. The study will use a treatment called Trulicity, which is a solution for injection containing the active substance dulaglutide. This medication is part of a group of drugs known as GLP-1 receptor agonists, which are used to help control blood sugar levels.

The purpose of the study is to see if using GLP-1 receptor agonists right after a kidney transplant can prevent the development of diabetes in people who are at high risk. Participants in the study will receive either the medication or a placebo. The study will follow participants for a period of up to 12 months, with regular check-ups to monitor their health and any changes in their condition. During these visits, various health indicators such as blood sugar levels, weight, and kidney function will be assessed.

This trial aims to provide valuable information on whether early treatment with Trulicity can help prevent diabetes in kidney transplant recipients. The study will also look at other health factors, including the need for additional diabetes medications, changes in body weight, and overall kidney health. The results could lead to better management strategies for preventing diabetes in people who have undergone a kidney transplant.

1 joining the study

Upon joining the study, participants are identified as de novo kidney transplant recipients who are older than 18 years and have no history of diabetes. Participants must meet specific criteria, such as receiving tacrolimus and prednisone as maintenance treatment and having a high risk of developing diabetes after the transplant.

2 initial treatment phase

Participants begin treatment with dulaglutide, administered as an injectable solution. The product used is Trulicity 0.75 mg solution for injection in a pre-filled pen. This treatment aims to prevent the onset of diabetes after the kidney transplant.

3 monitoring and assessment at 3 months

At 3 months post-transplant, participants undergo assessments to determine the proportion of patients with prediabetes and diabetes. This includes measuring fasting glucose levels and conducting an oral glucose tolerance test (OGTT).

Additional evaluations include monitoring the number and type of additional medications for diabetes control, insulin sensitivity, weight changes, renal function, and lipid profile.

4 ongoing treatment and monitoring

Participants continue to receive the dulaglutide treatment and are monitored for any treatment interruptions, acute rejection episodes, infections, and cardiovascular events.

Regular assessments of insulin sensitivity, weight, renal function, and lipid profile are conducted at 6 and 12 months post-transplant.

5 final assessment at 12 months

At 12 months, a comprehensive evaluation is performed to assess the proportion of patients with prediabetes and diabetes, renal biopsy lesions, and differences in immunosuppression levels.

The study also examines the incidence of death, graft loss, and other health outcomes.

Who Can Join the Study?

Must be a new kidney transplant recipient who is older than 18 years.
Must not have a history of diabetes. This means no previous diagnosis of diabetes, either from medical records or personal information, and a blood test called HbA1c should be 6.5% or lower before the transplant.
Must be taking medications called tacrolimus and prednisone to help prevent the body from rejecting the new kidney after the transplant.
Must have a high risk of developing diabetes after the transplant, which is determined by having two of the following factors:
- Being older than 50 years.
- Having a Body Mass Index (BMI) of 30 or higher. BMI is a measure of body fat based on height and weight.
- Having a close family member with diabetes.
- Having high levels of triglycerides, which are a type of fat in the blood, greater than 2.82 mmol/L.
- Having prediabetes, which means blood sugar levels are higher than normal but not high enough to be classified as diabetes. This can be shown by:
  - Fasting blood sugar levels between 100-126 mg/dL (5.6-6.9 mmol/L).
  - HbA1c levels between 5.7-6.4%.
  - If available, a test called an oral glucose tolerance test showing initial blood sugar less than 126 mg/dL (7 mmol/L) and 2 hours after a sugary drink between 140-200 mg/dL (7.8-11 mmol/L).
Women who can have children must use effective birth control while participating in the study.

Who Cannot Join the Study?

Patients who are not in the age range of 18 to 64 years old.
Patients who are not considered high-risk for developing diabetes after a kidney transplant.
Patients who are not in the immediate period following a kidney transplant.
Patients who are already diagnosed with diabetes before the kidney transplant.
Patients who are part of a vulnerable population, meaning they might need special protection or care.

Where you can join this trial?

Verified and Recommended Sites

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Verified Sites

Site Name	City	Country	Status
Bellvitge University Hospital	L'hospitalet De Llobregat	Spain

Other Sites

No sites found in this category

Trial status

Country	Status	Recruitment Start
Spain	Not recruiting	30.11.2023

Trial locations

Investigated drugs:

Dulaglutide

GLP-1 Receptor Agonists are medications used in this trial to help prevent the development of diabetes in patients who have recently received a kidney transplant. These medications work by helping the body produce more insulin when needed and reducing the amount of sugar produced by the liver. They also slow down the digestion process, which can help control blood sugar levels. The goal of using GLP-1 receptor agonists in this study is to see if they can prevent new cases of diabetes in patients who are at high risk after their kidney transplant.

Investigated diseases:

Renal transplant

Post-Kidney Transplant Diabetes – This condition refers to the development of diabetes in individuals who have undergone a kidney transplant. It is characterized by elevated blood sugar levels that meet the criteria for diabetes as defined by the American Diabetes Association. The condition can manifest as either prediabetes or full diabetes, often identified through fasting glucose tests or oral glucose tolerance tests. The progression involves monitoring changes in insulin sensitivity and metabolic control over time. Patients may experience variations in weight, body mass index, and waist circumference as part of the condition’s progression. Regular assessments of renal function and lipid profiles are also important in understanding the disease’s impact on overall health.

Trial ID:

2023-506437-29-00

Trial Phase:

Therapeutic confirmatory (Phase III)

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Study on Dulaglutide for Preventing Diabetes in New Kidney Transplant Patients

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