Study on Semaglutide for Preventing Metabolic Issues in Prediabetic or Diabetic Patients with Schizophrenia on Clozapine or Olanzapine

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What is this study about?

This clinical trial is focused on studying the effects of a medication called semaglutide on patients with schizophrenia who also have prediabetes or type 2 diabetes. Schizophrenia is a mental health condition that affects how a person thinks, feels, and behaves. Prediabetes and type 2 diabetes are conditions where blood sugar levels are higher than normal, which can lead to various health issues. The study will compare the effects of semaglutide, which is given as a solution for injection, with a placebo. The purpose of the study is to see if semaglutide can help prevent the worsening of the metabolic state, which refers to the body’s ability to process and use energy, in these patients.

Participants in the study will receive either semaglutide or a placebo once a week for a period of 26 weeks. The study will monitor changes in various health indicators, including blood sugar levels, body weight, and other factors related to metabolism. The main focus will be on changes in glycated hemoglobin A1c (HbA1c), which is a measure of average blood sugar levels over time. Other aspects such as body weight, blood pressure, and quality of life will also be observed.

The study is designed for adults aged 18 to 65 who have started treatment with antipsychotic medications like clozapine or olanzapine, which are used to manage schizophrenia. These medications can sometimes affect metabolic health, so the study aims to explore whether semaglutide can offer benefits in this area. The trial will help researchers understand the long-term effects of semaglutide on metabolic health in this specific group of patients.

1 joining the study

Upon joining the study, participation is confirmed based on specific criteria. These include a diagnosis of prediabetes or type 2 diabetes and current treatment with clozapine or olanzapine for schizophrenia.

2 initial assessment

An initial assessment is conducted to establish baseline measurements. This includes checking levels of glycated hemoglobin A1c (HbA1c), body weight, and other health indicators.

3 medication administration

The study involves the administration of semaglutide or a placebo. Semaglutide is given as a subcutaneous injection once a week. The medication is provided in a pre-filled pen known as Ozempic 1 mg solution.

4 ongoing monitoring

Throughout the 26-week study period, regular monitoring is conducted. This includes tracking changes in HbA1c levels, body weight, and other health parameters such as blood pressure and heart rate.

5 final assessment

At the end of the study, a final assessment is performed. This involves measuring the same health indicators as the initial assessment to evaluate any changes.

Who Can Join the Study?

Must be between 18 and 65 years old.
Must have been diagnosed with schizophrenia.
Must have started daily treatment with either clozapine or olanzapine within the last 60 months. These are medications used to treat schizophrenia.
Must have been diagnosed with either prediabetes or type 2 diabetes. These are conditions related to high blood sugar levels.
For prediabetes, blood tests must show one of the following results, confirmed on a different day:
- HbA1c level between 35-47 mmol/mol. HbA1c is a test that shows average blood sugar levels over the past 2-3 months.
- Fasting plasma glucose (FPG) between 5.6-6.9 mM. This is a blood sugar test taken after not eating for at least 8 hours.
- Blood sugar level between 7.8-11.0 mM two hours after drinking a sugary drink during a test called OGTT (Oral Glucose Tolerance Test).
For type 2 diabetes, blood tests must show one of the following results, confirmed on a different day:
- HbA1c level between 48-57 mmol/mol.
- Fasting plasma glucose (FPG) between 6.9-9.9 mM.
- Blood sugar level greater than 11 mM two hours after drinking a sugary drink during the OGTT.
Both males and females can participate.

Who Cannot Join the Study?

Patients who are not between the ages of 18 and 65 years.
Patients who do not have a diagnosis of schizophrenia.
Patients who have not started treatment with the medications clozapine or olanzapine. These are specific medications used to treat schizophrenia.
Patients who do not have prediabetes or diabetes. Prediabetes means having higher than normal blood sugar levels, but not high enough to be classified as diabetes.

Where you can join this trial?

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Verified Sites

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Other Sites

Site Name	City	Country	Status
Psykiatrisk Center Kobenhavn	Copenhagen	Denmark

Trial status

Country	Status	Recruitment Start
Denmark	Not recruiting	01.09.2021

Trial locations

Investigated drugs:

Semaglutide

Semaglutide is a medication used in this study to see if it can help prevent worsening of the metabolic state in patients who have prediabetes or diabetes. It is given once a week and works by mimicking a hormone in the body that helps control blood sugar levels. The study is looking at its effects over a period of 26 weeks.

Clozapine is an antipsychotic medication used to treat schizophrenia. It helps manage symptoms such as hallucinations, delusions, and thought disorders. In this study, patients who are starting treatment with clozapine are being observed to see how it affects their metabolic state, especially if they have prediabetes or diabetes.

Olanzapine is another antipsychotic medication used to treat schizophrenia. Like clozapine, it helps control symptoms of the disorder. The study is examining its impact on the metabolic health of patients with prediabetes or diabetes who are beginning treatment with olanzapine.

Schizophrenia – Schizophrenia is a chronic mental health disorder that affects how a person thinks, feels, and behaves. Individuals with schizophrenia may experience symptoms such as hallucinations, delusions, and disorganized thinking. These symptoms can lead to difficulties in distinguishing between what is real and what is not. The disorder often begins in late adolescence or early adulthood and can vary in severity. Over time, it may lead to social withdrawal and challenges in daily functioning. The progression of schizophrenia can be influenced by various factors, including environmental and genetic components.

Trial ID:

2024-518746-24-00

NCT ID:

NCT04892199

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on Semaglutide for Preventing Metabolic Issues in Prediabetic or Diabetic Patients with Schizophrenia on Clozapine or Olanzapine

What is this study about?

Who Can Join the Study?

Who Cannot Join the Study?