Study on the Effects of Pasireotide in Patients with Low Blood Sugar After Bariatric Surgery

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What is this study about?

This clinical trial is focused on studying a condition known as Post-Bariatric Hypoglycemia (PBH), which can occur in some individuals after they have undergone weight-loss surgery. This condition is characterized by low blood sugar levels after eating, which can lead to symptoms like dizziness, confusion, and even fainting. The study is testing a treatment called Pasireotide Diaspartate, which is a type of medication that mimics a natural hormone in the body to help control blood sugar levels. The medication is given as a solution for injection under the skin.

The purpose of the study is to evaluate how effective and safe Pasireotide Diaspartate is in managing blood sugar levels in patients with PBH. Participants in the study will receive either the medication or a placebo, which is an inactive substance, to compare the effects. The study will last for a period of 12 weeks, during which participants will be monitored for changes in their blood sugar levels and any side effects they may experience. The study aims to find the most effective dose of the medication that can help manage the symptoms of PBH.

Throughout the study, participants will undergo regular assessments to track their blood sugar levels and overall health. These assessments will help researchers understand how Pasireotide Diaspartate affects the body and its potential benefits for people with Post-Bariatric Hypoglycemia. The study is designed to provide valuable information that could lead to better treatment options for individuals experiencing this condition after bariatric surgery.

1 joining the study

Upon joining the study, the patient will receive training on how to self-inject the study medication. This training is essential for the administration of the medication throughout the trial.

2 medication administration

The patient will be randomly assigned to receive either pasireotide or a placebo. The medication is administered as a subcutaneous injection, which means it is injected under the skin.

The dosage of pasireotide will be either 50 micrograms, 100 micrograms, or 200 micrograms, taken three times a day (tid). The placebo will be administered with the same frequency.

3 treatment duration

The initial treatment phase lasts for 12 weeks. During this period, the patient will continue to self-administer the assigned medication or placebo as instructed.

4 monitoring and assessments

Throughout the trial, the patient’s blood glucose levels will be monitored. This includes measuring changes in blood glucose levels from the start of the trial to the end of the 12-week treatment period.

The patient will also be assessed for the frequency and severity of hypoglycemic events, which are episodes of low blood sugar.

5 extension phase

After the initial 12-week period, there is an optional extension phase. This phase allows for continued treatment and monitoring for up to 48 weeks.

During the extension phase, the same monitoring and assessments will continue to ensure the safety and efficacy of the treatment.

6 end of trial

The trial is expected to conclude by February 2026. At the end of the trial, final assessments will be conducted to evaluate the overall outcomes of the treatment.

Who Can Join the Study?

Must be a male or a non-pregnant female who is 18 years or older.
Must have stopped any previous treatments for Post-Bariatric Hypoglycaemia (PBH), such as acarbose, gama guar, pectin, or diazoxide, for at least 2 weeks before the study.
Must not have used GLP-1 antagonists or GLP-1 agonists for at least 4 weeks before the study. These are medications that affect blood sugar levels.
Must not have used SGLT2 inhibitors for at least 4 weeks before the study. These are medications that help the body remove excess sugar through urine.
If previously treated with somatostatin receptor analogues, must wait a specific time before starting the study, depending on the type of medication used:

Octreotide s.c.: wait at least 3 days
Octreotide LAR: wait at least 8 weeks
Lanreotide Autogel: wait at least 14 weeks
Lanreotide SR: wait at least 4 weeks
Pasireotide s.c.: wait at least 3 days
Pasireotide LAR: wait at least 12 weeks

Must be able to provide signed written consent to participate in the study.
Must be able to self-inject the study medication under the skin. Training will be provided.
Must have had bariatric surgery more than 6 months before joining the study. Bariatric surgery is a type of surgery to help with weight loss.
Must have a documented diagnosis of Post-Bariatric Hypoglycaemia (PBH), with low blood sugar levels and symptoms that improve after eating carbohydrates.
Must have experienced at least 4 episodes of low blood sugar after meals during a 28-day period, defined as:

Blood sugar less than 54 mg/dL
Symptoms of neuroglycopenia, which means the brain is not getting enough sugar
Severe low blood sugar event

Must have tried controlling symptoms with diet, but it was not enough.
Must have a Karnofsky Performance Status of 60 or higher, meaning they may need some help but can take care of most personal needs. This is a scale used to measure a person’s ability to perform daily activities.

Who Cannot Join the Study?

Patients who are not diagnosed with Post-Bariatric Hypoglycaemia (a condition where blood sugar levels drop too low after weight-loss surgery) cannot participate.
Patients who are not within the specified age range for the study cannot participate.
Patients who belong to a clinical trial group that is not included in this study cannot participate.
Patients who are part of a vulnerable population, which means they might need special protection or care, cannot participate.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name	City	Country
Fondazione Policlinico Universitario Agostino Gemelli IRCCS	Rome	Italy
Hospital Clinico San Carlos	Madrid	Spain
Oncopole Claudius Regaud	Toulouse	France
Katholieke Universiteit te Leuven	Leuven	Belgium

Other Sites

Site Name	City	Country
Hospital Universitario 12 De Octubre	Madrid	Spain
Azienda Ospedaliera Universitaria Policlinico Paolo Giaccone	Palermo	Italy
Azienda Ospedaliera di Padova	Padua	Italy
Hospital Clinic De Barcelona	Barcelona	Spain
Hospital Universitari De Girona Doctor Josep Trueta	Girona	Spain
Centre Hospitalier Lyon Sud	Pierre Benite	France
Hopital Beaujon	Clichy	France
Aemlzrs Ujnij Snkabqzvl Llnkwo Dv Bbsiuqc	Bologna	Italy
Hcxuppoe Uuxinmpnrisws Hgzwxucp Tljyu y Ppmmcz Ixeuqzrk Ceswbl dplmofwggahcxlvew (cmqs	Badalona	Spain
Hdxqfwwp Vfxu dfmdbgoq	Barcelona	Spain

Trial status

Country	Status	Recruitment Start
Belgium	Not recruiting	01.04.2024
France	Not recruiting	01.04.2024
Italy	Not recruiting	01.04.2024
Spain	Not recruiting	01.04.2024

Trial locations

Investigated drugs:

Pasireotide is a medication being studied for its ability to help manage blood sugar levels in patients who experience low blood sugar after undergoing bariatric surgery. This condition is known as Post-Bariatric Hypoglycaemia (PBH). The trial aims to determine how effective and safe pasireotide is when given as a subcutaneous injection over a period of 12 weeks.

Investigated diseases:

Post-Bariatric Hypoglycemia – This condition occurs in some individuals who have undergone bariatric surgery, a procedure to aid weight loss. It is characterized by episodes of low blood sugar, or hypoglycemia, which can happen after eating. The condition arises due to changes in how the body processes food, leading to excessive insulin production. Symptoms may include shakiness, sweating, confusion, and in severe cases, loss of consciousness. These episodes typically occur one to three hours after meals. The condition can significantly impact daily life, requiring careful management of diet and lifestyle.

Trial ID:

2023-505316-37-00

Protocol code:

SOM230-RECAG-CL-0576

NCT ID:

NCT05928390

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on the Effects of Pasireotide in Patients with Low Blood Sugar After Bariatric Surgery

What is this study about?

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