Pasireotide s.c. in Patients With Post-Bariatric Hypoglycaemia
This research study is looking into a new medicine called pasireotide for adults who have low blood sugar, known as post-bariatric hypoglycaemia (PBH), after weight-loss surgery. PBH can cause unpleasant symptoms like dizziness or confusion. The study wants to find out if different doses of pasireotide, given as an injection under the skin, can safely and effectively help manage these low blood sugar episodes. Participants will take the medicine or a dummy treatment (placebo) for 12 weeks, followed by an optional longer period where everyone receives the active medicine. The study lasts about a year in total, including check-ups.
At a glance
What is this study about?
You might be reading this because you've had weight-loss surgery and are now experiencing problems with low blood sugar, which doctors call post-bariatric hypoglycaemia (PBH). This can be a challenging condition, making you feel unwell with symptoms like shakiness, confusion, or even fainting. The good news is that researchers are looking for better ways to help people like you manage these symptoms and improve their quality of life.
This study is testing a new medicine called pasireotide. It's hoped that this medicine might help to keep blood sugar levels more stable, preventing them from dropping too low. By doing this, the researchers hope to reduce the number of low blood sugar episodes you experience and make you feel better day-to-day. This is a "Phase 2" study, which means it's one of the earlier stages of testing new drugs in people, focusing on finding the right dose and checking for safety.
The study is important because it could lead to a new treatment option for people living with PBH. Currently, dietary changes are often the first step in managing PBH, but for some, this isn't enough. Finding a medication that can effectively control blood sugar in these cases would be a big step forward.
Key takeaways
- This study is for adults with low blood sugar after weight-loss surgery.
- It's testing a new medicine, pasireotide, to see if it can help control blood sugar and symptoms.
- You'll give yourself injections three times a day, and for 12 weeks, you might get a dummy treatment.
- The total study time is about a year, with regular check-ups.
- You can stop participating at any time if you wish.
Who may be eligible?
To join this study, you need to be an adult (18 years or older) and have been diagnosed with low blood sugar (PBH) after having weight-loss surgery at least six months ago. You should be experiencing at least four low blood sugar events per month that cause symptoms and are confirmed by a blood glucose test below a certain level.
It's important that you can give your own injections under the skin, though you'll be taught how to do this for the study medication. You also need to be in generally good health and able to manage most of your daily activities with only a little help. If you're on certain other medications for low blood sugar or diabetes, you'll likely need to stop them for a period before joining, as these could affect the study results.
There are also reasons you might not be able to join, such as if you are pregnant, have certain other medical conditions, or are taking medications that could interfere with the study medicine. The doctors will check all of this carefully to make sure the study is safe and right for you.
Could this study suit you?
Answer these quick questions to see if you may be eligible. This is a guide only — the research team makes the final call.
- Are you 18 years old or older?
- Did you have weight-loss surgery more than 6 months ago?
- Do you get low blood sugar (hypoglycaemia) after meals, with symptoms?
- Are you able to give yourself injections under the skin (with training)?
- Have you tried dietary changes for your low blood sugar, but they haven't been enough?
What does participation involve?
If you join the study, your total involvement will last up to 59 weeks (about a year and a month). It starts with up to 3 weeks of screening to check if you're suitable. Then, there's a 4-week period where you won't take any study medication, which helps set a baseline.
Next, you'll enter the 'Blinded Treatment Phase' for 12 weeks. During this time, you'll give yourself an injection under the skin three times a day, before each meal. You won't know if you're receiving pasireotide at one of three different doses (50, 100, or 200 micrograms) or a dummy treatment (placebo). This is called 'blinded' because neither you nor the study team will know which you're getting.
After these 12 weeks, if you complete this part, you'll be offered the chance to continue into an 'Extension Phase' for 36 weeks. In this phase, everyone receives the active pasireotide medicine, and the dose might be adjusted by the doctor. Finally, there's a 4-week follow-up period after you stop treatment to check on your health and safety.
Potential risks and benefits
Locations (29)
- Stanford University School of Medicine, Endocrinology, 800 Welch Road,Verified postcodePalo Alto, United States
- Northwestern University - Feinberg School of Medicine - Ann & Robert H. Lurie Children's Hospital of ChicagoVerified postcodeChicago, United States
- NOLA CareVerified postcodeMetairie, United States
- Velocity Clinical Research - AnnapolisVerified postcodeAnnapolis, United States
- Joslin Diabetes CenterJoslin Diabetes Center, One Joslin PlaceVerified postcodeBoston, United States
- Mayo Clinic - Rochester, 200 First Street, SW, 55905Verified postcodeRochester, United States
- Montefiore Medical Center, 111 E 210th Street,Verified postcodeThe Bronx, United States
- Vanderbilt University Medical CenterVerified postcodeNashville, United States
- University of Texas Health Science Center at San Antonio, 7703 Floyd Curl Dr,Verified postcodeSan Antonio, United States
- University of Wisconsin Health W. E. Clinic END, 451 Junction Rd,Verified postcodeMadison, United States
- Universitaire Ziekenhuizen Leuven, Department of Gastroenterology and Hepatology,Herestraat 49Verified postcodeLeuven, Belgium
- AP-HP Hopital Europeen Georges Pompidou, 20, rue Leblanc,Verified postcodeParis, France
Common questions
What is post-bariatric hypoglycaemia (PBH)?
PBH is when your blood sugar drops too low after weight-loss surgery, causing symptoms like dizziness, shakiness, or confusion.
What is pasireotide?
Pasireotide is the name of the medicine being tested in this study to see if it can help manage low blood sugar.
Will I know if I'm getting the real medicine or a dummy treatment?
For the first 12 weeks, neither you nor the doctors will know if you're getting pasireotide or a dummy treatment (placebo). This helps us understand the medicine's true effects. After that, everyone gets the active medicine.
How will I take the study medicine?
You'll give yourself an injection under the skin three times a day, before each meal. You'll be fully trained on how to do this safely.
How long will I be in the study?
The study lasts for a maximum of 59 weeks, which includes screening, a period without treatment, taking the study medicine, and a final safety check-up.
How to find out more
Always speak to your GP or specialist before deciding to take part in a study.
Discussion
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