Ongoing Clinical Trials for Postprandial Hypoglycaemia
There is currently 1 clinical trial investigating treatments for postprandial hypoglycaemia, specifically focusing on patients who experience low blood sugar after bariatric surgery. This trial is testing a medication called pasireotide and is taking place across multiple European countries.
Clinical trial locations
- Belgium
- France
- Italy
- Spain
Study on the Effects of Pasireotide in Patients with Low Blood Sugar After Bariatric Surgery
This clinical trial is examining a condition called Post-Bariatric Hypoglycaemia, which can develop in some people after they have had weight-loss surgery. The condition causes blood sugar levels to drop too low after eating, leading to symptoms like dizziness, confusion, and sometimes fainting. These episodes typically occur one to three hours after meals and can significantly impact daily life.
Main inclusion criteria: Participants must be at least 18 years old and have had bariatric surgery more than 6 months before joining the study. They must have a documented diagnosis of Post-Bariatric Hypoglycaemia with low blood sugar levels and symptoms that improve after eating carbohydrates. Participants need to have experienced at least 4 episodes of low blood sugar after meals during a 28-day period, where blood sugar dropped below 54 mg/dL, accompanied by symptoms indicating the brain is not getting enough sugar, or severe low blood sugar events. Patients must have already tried controlling symptoms through diet alone without sufficient success. They must also be able to self-inject medication under the skin after receiving training and have a Karnofsky Performance Status of 60 or higher, meaning they can take care of most personal needs with some help.
Before joining the study, participants must have stopped any previous treatments for this condition, such as acarbose, gama guar, pectin, or diazoxide, for at least 2 weeks. They must not have used GLP-1 antagonists, GLP-1 agonists, or SGLT2 inhibitors for at least 4 weeks. If previously treated with somatostatin receptor analogues, specific waiting periods apply depending on the medication type, ranging from 3 days to 14 weeks.
Main exclusion criteria: The study excludes patients who do not have a diagnosis of Post-Bariatric Hypoglycaemia, those who are outside the specified age range, patients belonging to clinical trial groups not included in this study, and those who are part of vulnerable populations requiring special protection or care.
Focus and goal: The trial is testing whether Pasireotide Diaspartate can effectively and safely manage blood sugar levels in patients with this condition. The medication is a type of drug that mimics somatostatin, a natural hormone in the body that helps control blood sugar levels by inhibiting the release of several other hormones. Participants will receive training on how to self-inject the medication under the skin. They will then be randomly assigned to receive either pasireotide at one of three different doses (50, 100, or 200 micrograms) or a placebo, taken three times daily.
The initial treatment phase lasts 12 weeks, during which participants will continue to self-administer their assigned medication. Throughout this period, researchers will monitor blood glucose levels and track the frequency and severity of low blood sugar episodes. After the initial 12 weeks, there is an optional extension phase allowing for continued treatment and monitoring for up to 48 weeks. The trial is expected to conclude by February 2026, at which point final assessments will evaluate the overall outcomes of the treatment.
Investigational drug: The study is testing pasireotide, administered as a subcutaneous injection. This medication is classified as a somatostatin analog and works by helping to regulate blood sugar levels, which is particularly important for patients experiencing excessive insulin production after eating following bariatric surgery.
Summary
Currently, only one clinical trial is actively investigating treatments for postprandial hypoglycaemia related to bariatric surgery. This trial is taking place across four European countries: Spain, Belgium, France, and Italy, providing access to patients in multiple locations. The study focuses specifically on pasireotide as a potential treatment option for managing Post-Bariatric Hypoglycaemia, a condition that can significantly affect quality of life for patients who have undergone weight-loss surgery. The trial’s design includes both a core 12-week treatment phase and an optional extension period, allowing researchers to gather comprehensive data on both short-term and longer-term effects of the medication.
