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Study on the Effects of Exenatide in Patients with Hypopituitarism and Oxytocin Deficiency

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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 hypopituitarism, a condition where the pituitary gland does not produce enough hormones. The study will explore the effects of a medication called Byetta, which contains the active substance exenatide. This medication is a type of glucagon-like peptide analogue, which is usually used to help control blood sugar levels in people with diabetes. In this study, it will be used to understand its impact on hormone secretion in patients with hypopituitarism.

The purpose of the study is to improve knowledge about how the body naturally produces a hormone called oxytocin in people with hypopituitarism. Participants will receive either the study medication or a placebo, and the study will follow a randomized, crossover design. This means that participants will receive both the medication and the placebo at different times during the study. The study will look at how the medication affects the pattern of oxytocin hormone secretion.

Throughout the study, researchers will also assess various aspects of participants' well-being, such as mood, quality of life, and eating behavior, to see how these might be related to changes in oxytocin levels. The study is expected to continue until the end of 2024, providing valuable insights into the relationship between hypopituitarism and oxytocin production.

The research process

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

Step 1
Joining the study
Upon joining the study, you will be informed about the purpose and procedures involved. You will be asked to provide consent to participate in the trial.
Step 2
Initial assessment
An initial assessment will be conducted to confirm your eligibility. This includes verifying your age, medical history, and current health status. You must be between 18 and 65 years old and have a condition known as hypopituitarism, which involves a deficiency in more than one pituitary hormone.
Step 3
Hormone replacement therapy check
It is important that you have been on stable hormone replacement therapy for at least three months before the study begins. This ensures that your hormone levels are consistent during the trial.
Step 4
Study visits scheduling
If you are a woman, your study visits will be scheduled during the follicular phase of your menstrual cycle, which is between day 1 and 10. This is to minimize the effects of hormonal changes on the study results.
Step 5
Administration of study medication
You will receive the study medication, which is a solution for injection called Byetta. It contains the active substance exenatide and is administered via a subcutaneous injection. The dosage and frequency will be explained to you by the study team.
Step 6
Monitoring and assessments
Throughout the study, your hormone levels will be monitored to observe the pattern of oxytocin secretion after receiving the study medication. You will also complete questionnaires to assess mood, quality of life, and other factors.
Step 7
Completion of the study
At the end of the study, a final assessment will be conducted. This will include a review of your health status and any changes observed during the trial. The study is expected to conclude by December 31, 2024.

Who can join the trial?

11 criteria

Age between 18 and 65 years.
Patients with hypopituitarism (HIPO), which means having more than one hormone deficiency from the pituitary gland, along with at least one sign of damage to the hypothalamus, a part of the brain.
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Signs of possible hypothalamic damage include:
- Central diabetes insipidus, a condition causing excessive thirst and urination.
- Severe obesity.
- Hyperphagia, which means excessive eating.
- MRI scans suggesting damage to the hypothalamus.
- History of traumatic brain injury.
- History of radiation treatment for tumors affecting the hypothalamic area, such as craniopharyngioma or germinoma.
- HIPO patients must be on stable hormone replacement therapy for at least three months before the study.
- Women participating in the study should schedule visits during the follicular phase of their menstrual cycle, which is between day 1 and day 10, to reduce the effects of increased estradiol, a hormone, on OT levels. Postmenopausal women with HIPO will be compared with women of similar age without HIPO.
- Healthy individuals without HIPO, matched by body mass index (BMI), age, and sex with HIPO patients, can also participate as controls.

Who cannot join the trial?

5 criteria

Patients with **hypopituitarism** cannot participate. Hypopituitarism is a condition where the pituitary gland does not produce enough hormones.
Patients with **CS** cannot participate. CS refers to a specific medical condition related to the study.
Patients who are not within the specified age range cannot participate. The study is for a specific age group.
Patients who do not meet the gender requirements cannot participate. The study includes both male and female participants.
Patients who are considered part of a vulnerable population cannot participate. This means individuals who may need special protection or care.

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Hospital De La Santa Creu I Sant Pau
Barcelona, Spain

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Investigated drugs

Oxytocin is a hormone that is naturally produced in the body. It plays a key role in social bonding, sexual reproduction, and during and after childbirth. In this clinical trial, oxytocin is being studied to understand its secretion in patients with certain medical conditions. The goal is to see if there is a deficiency in oxytocin levels and how it might affect the patients' health. By studying oxytocin, researchers hope to learn more about its importance and potential therapeutic uses for people with specific hormonal imbalances.

Exenatide

What is already known about the treatment

Oxytocin – Oxytocin is typically administered as an injection or nasal spray, and it is being studied for its potential role in treating hypopituitarism, a condition where the pituitary gland does not produce enough hormones. Currently, oxytocin is well-known in medical literature for its role in childbirth and lactation, but its broader effects on social bonding and emotional regulation are also being explored. The main therapeutic indication in this study is to understand its secretion in patients with hypopituitarism. At the molecular level, oxytocin works by binding to specific receptors in the brain, influencing social and emotional behaviors. It is classified pharmacologically as a neuropeptide hormone.

Investigated diseases

Hypopituitarism – Hypopituitarism is a condition where the pituitary gland fails to produce one or more of its hormones or not enough of them. This gland, located at the base of the brain, is responsible for regulating various bodily functions through hormone production. The progression of hypopituitarism can vary, with symptoms developing slowly over time or appearing suddenly. Common symptoms include fatigue, weakness, weight loss, and decreased libido, which result from the deficiency of hormones like growth hormone, thyroid-stimulating hormone, and others. As the condition advances, it can lead to more severe symptoms affecting growth, metabolism, and reproductive functions. The severity and range of symptoms depend on which hormones are lacking and the underlying cause of the pituitary dysfunction.