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Study on Dulaglutide for Preventing Diabetes in Patients with Metabolic Syndrome Awaiting Kidney Transplantation

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 the effects of a medication called Trulicity, which contains the active substance dulaglutide. The study is aimed at patients who are on the waiting list for a kidney transplant and have a condition known as metabolic syndrome. Metabolic syndrome is a group of conditions that occur together, increasing the risk of heart disease, stroke, and type 2 diabetes. These conditions include high blood sugar, excess body fat around the waist, and abnormal cholesterol or triglyceride levels.

The purpose of the study is to see if treatment with Trulicity can help reverse metabolic syndrome in these patients. The study will last for up to six months, during which participants will receive the medication as an injection. The researchers will check the participants' health status at three and six months to see if there are improvements in their metabolic syndrome. Some participants may receive a placebo, which is a substance with no active medication, to compare the effects.

Throughout the study, the researchers will monitor various health indicators, such as blood sugar levels and body weight, to assess changes in the participants' conditions. They will also keep track of any side effects, such as nausea, diarrhea, or headaches, and any changes in insulin sensitivity, which is how well the body responds to insulin. The study aims to provide valuable information on whether Trulicity can be an effective preventive treatment for diabetes in patients awaiting kidney transplants.

The research process

The trial runs in 7 steps – from screening to follow-up. Each step says what happens and what the team monitors.

  1. Step 1

    Joining the study

    Upon joining the study, eligibility is confirmed based on specific criteria such as being on the kidney transplant waiting list, being over 18 years old, and having metabolic syndrome.

    Women of childbearing potential must use effective contraceptive measures during participation.

  2. Step 2

    Initial assessment

    An initial assessment is conducted to evaluate the current health status, including measurements of fasting plasma glucose, waist circumference, and other metabolic syndrome indicators.

  3. Step 3

    Medication administration

    The medication Trulicity (dulaglutide) is administered as a solution for injection using a pre-filled pen.

    The dosage is 0.75 mg, and it is administered once a week.

  4. Step 4

    3-month evaluation

    After 3 months of treatment, an evaluation is conducted to assess changes in metabolic syndrome indicators.

    The primary goal is to determine if there is a reversal of metabolic syndrome.

  5. Step 5

    6-month evaluation

    If treatment continues, a 6-month evaluation is performed to further assess the reversal of metabolic syndrome.

    Additional assessments include insulin sensitivity and changes in abdominal obesity.

  6. Step 6

    Monitoring and reporting

    Throughout the study, any adverse reactions such as nausea, diarrhea, or injection site pain are monitored.

    Participants are required to report any severe hypoglycemic episodes or other significant side effects.

  7. Step 7

    Completion of study

    The study is estimated to conclude by December 31, 2026.

    Final assessments are conducted to evaluate the overall effectiveness of the treatment in reversing metabolic syndrome.

Who can join the trial?

9 criteria

  • Patients must be on the waiting list for a kidney transplant.
  • Patients must be over 18 years old.
  • Women who can have children must use effective birth control methods while participating in the study.
  • Patients must have metabolic syndrome, which is a group of conditions that occur together. This is defined by having 3 or more of the following:
    • Prediabetes, which means having higher than normal blood sugar levels but not high enough to be diabetes. This can be shown by:
      • Fasting blood sugar levels between 100-126 mg/dL (5.6-6.9 mmol/L).
      • Blood sugar levels less than 126 mg/dL (7 mmol/L) with a 2-hour blood sugar level after drinking a sugary drink between 140-200 mg/dL (7.8-11 mmol/L).
      • HbA1c, a measure of average blood sugar over 3 months, between 5.7-6.4%.
      • Obesity, which means having a body mass index (BMI) of 27 or higher. BMI is a measure of body fat based on height and weight.
      • High triglycerides, which are a type of fat in the blood, of 150 mg/dL or higher, or if the patient is already being treated for high triglycerides.
      • Large waist circumference, which means a waist size greater than 101.6 cm for men or 88.9 cm for women.

Who cannot join the trial?

5 criteria

  • Patients who do not have **metabolic syndrome**. This is a group of conditions that occur together, increasing the risk of heart disease, stroke, and type 2 diabetes.
  • Patients who are not on the **waiting list for kidney transplantation**.
  • Patients who do not meet at least two of the following criteria: **prediabetes** (higher than normal blood sugar levels), **abdominal obesity** (excess fat around the stomach), **hypertriglyceridemia** (high levels of triglycerides in the blood), and/or **dyslipidemia** (abnormal amount of lipids in the blood).
  • Patients who are not willing or able to follow the treatment plan for 3 to 6 months.
  • Patients who are part of a **vulnerable population**. This means groups of people who might be at a higher risk of harm or exploitation.
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Investigated drugs

GLP-1 Receptor Agonists are medications used in this trial to help manage blood sugar levels. They work by mimicking a hormone in the body that stimulates insulin release, which helps lower blood sugar. In this study, they are being tested to see if they can prevent diabetes in patients who are waiting for a kidney transplant and have metabolic syndrome. The goal is to see if these medications can improve the patients' metabolic health before they receive a transplant.

What is already known about the treatment

GLP-1 Receptor Agonists – These medications are administered via injection and are currently being studied for their potential to prevent diabetes in patients awaiting kidney transplantation. They are well-documented in medical literature for their role in managing metabolic syndrome, particularly in individuals with a high risk of developing diabetes. The primary therapeutic indication is to reverse metabolic syndrome in patients on the kidney transplant waiting list. At the molecular level, GLP-1 receptor agonists work by mimicking the action of the natural hormone GLP-1, which increases insulin secretion and decreases glucagon release, thereby helping to regulate blood sugar levels. They are classified pharmacologically as incretin mimetics.

Investigated diseases

Metabolic Syndrome – Metabolic syndrome is a cluster of conditions that occur together, increasing the risk of heart disease, stroke, and type 2 diabetes. These conditions include increased blood pressure, high blood sugar, excess body fat around the waist, and abnormal cholesterol or triglyceride levels. The syndrome is closely linked to overweight or obesity and inactivity. It progresses as these risk factors worsen, potentially leading to more severe health issues. The presence of metabolic syndrome is determined by having at least three of these risk factors. It is often associated with insulin resistance, where the body does not use insulin effectively.
Trial detailsLast updated 7 Oct 2026
Age18+ yearsPhasePhase IIITrial ID2023-506436-33-00Estimated enrolment20 patientsSponsorBellvitge University Hospital

sourced from the EU Clinical Trials Register and site verification

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