Not yet recruiting

A study to evaluate if atorvastatin prevents gallstones in patients undergoing bariatric surgery

Verified siteRegistered drugNo placebo

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

What is this trial about?

A plain-language summary of the goals, design and what participants do

This study focuses on the prevention of gallstones, which are hard deposits that can form in the gallbladder, in people who have undergone bariatric surgery, a procedure used for significant weight loss. The purpose of the study is to evaluate whether the medication atorvastatin can help prevent these stones from forming. This medication is an oral drug used to lower cholesterol, a fatty substance found in the blood.

Participants in the study will receive either atorvastatin or standard care. If atorvastatin is used, it is taken once daily, starting two weeks before the surgery and continuing for six months afterward. The study will monitor changes in LDL-cholesterol, which is often referred to as bad cholesterol, as well as levels of bile acids, which are substances produced by the liver to help digest fats. The process includes monitoring for any side effects related to the medication during the period following the surgery.

The research process

The trial runs in 3 steps – from screening to follow-up. Each step says what happens and what the team monitors.

Step 1
Pre-surgery medication phase
Two weeks before the bariatric surgery (a procedure to help with weight loss), a daily dose of 40 mg of atorvastatin is taken by mouth.
Atorvastatin is a medication used to lower cholesterol (a fatty substance in the blood).
Step 2
Surgery and post-surgery phase
The atorvastatin dose of 40 mg is continued once every day for six months after the surgery.
During this period, the formation of gallstones (hard deposits in the gallbladder) is monitored.
Ultrasound examinations (a medical test that uses sound waves to look inside the body) are used to check for gallstones.
Step 3
Monitoring and evaluation
Changes in LDL-cholesterol levels (often called bad cholesterol) are measured by comparing levels from the start of the study to the six-month mark.
Levels of bile acids (substances that help with digestion) are measured in the blood and in stool samples at the beginning and after six months.
Any adverse events (side effects or unexpected medical issues) related to the medication are recorded.

Who can join the trial?

6 criteria

You must be scheduled for a weight loss surgery, specifically a laparoscopic Roux-en-Y gastric bypass (a procedure where part of the stomach is bypassed) or a sleeve gastrectomy (a procedure where a large part of the stomach is removed to limit food intake).
Laparoscopic means the surgery is performed using small incisions and a tiny camera.
You must have a gallbladder, which is a small organ under the liver that stores bile, that is currently healthy and has no gallstones (hardened deposits of digestive fluid).
A doctor must confirm your gallbladder is healthy using an ultrasound, which is a test that uses sound waves to create images of the inside of your body.
Your LDL cholesterol level, often called "bad cholesterol," must be 2.0 mmol/L or higher.
mmol/L is a unit used to measure the amount of a substance, such as cholesterol, in your blood.

Who cannot join the trial?

9 criteria

You have had bariatric surgery (weight loss surgery) in the past.
You are currently taking PCSK9 inhibitors, statins, ezetimibe, or fibrates, which are different types of medications used to manage cholesterol.
You are known to be intolerant to statins, meaning your body has a bad reaction to this specific type of cholesterol medication.
You already have gallstones (small, hard deposits in your gallbladder), whether they are causing you pain or not, before your planned surgery.
You have familial hypercholesterolemia, which is an inherited condition that causes very high cholesterol levels from birth.
You have severe liver disease, measured by a specific scale called the Child-Pugh score (a tool doctors use to determine how well the liver is functioning).
You have severe renal impairment, which means your kidneys are not working well enough to filter your blood properly, measured by a value called eGFR.
You are taking CYP3A4 inhibitors, which are medicines that can interfere with how the study drug works and increase the risk of myopathy (a condition causing muscle weakness or pain).
You are taking CYP3A4 inducers, which are medicines that can lower the amount of the study drug in your blood, making it less effective.

Clinical Trials Concierge

Prefer not to search? Our Concierge searches the trials for you.

Tell us about your condition – we search every trial in Europe and connect you with the right site.

We usually reply within a few days

Verified sites

All sites with verified contact details – recruitment status may not be available; ask directly

Spaarne Gasthuis
Verified
Hoofddorp, The Netherlands

Trial locations

Where you can join this trial

Countries are shaded by recruitment status. Click a recruiting country to ask about joining there.

Not yet recruiting

Not finding your country?

Not sure what to do next?

Joining a clinical trial can seem overwhelming. We guide you step by step, so you know exactly what to expect and how we support you through the process.

See the full process and FAQ

Investigated drugs

Atorvastatin is a medication used to lower cholesterol levels in the blood. In this study, it is being tested to see if taking it before and after weight loss surgery can help prevent the development of gallstones.

Atorvastatin

What is already known about the treatment

Atorvastatin - This medication is taken as a pill by mouth once every day. It is a widely used and well-known drug that belongs to a group called statins, which are primarily used to lower high cholesterol levels in the blood. At the molecular level, it works by blocking a specific enzyme in the liver that is responsible for producing cholesterol. In this study, it is being investigated to see if it can help prevent the formation of gallstones in patients undergoing weight loss surgery.

Investigated diseases

Cholelithiasis - This condition occurs when hard deposits, known as stones, form inside the gallbladder. These stones are typically made of hardened digestive fluids like cholesterol or bile. The process often develops when the gallbladder does not empty correctly or when there is too much cholesterol in the bile. Over time, these deposits can grow in size or number. The formation can be triggered by various factors, including rapid changes in body weight.