RecruitingNAINTERVENTIONAL

Exploratory Evaluation of the Effect of Cholestyramine on Serum Levels of POPs in Obese Female Patients

This study aims to find out if a medication called cholestyramine can help lower levels of 'persistent organic pollutants' (POPs) in obese women. POPs are common chemicals found in our environment that can build up in body fat. When people have weight-loss surgery, these POPs can get released into the bloodstream as fat is lost, which might have health consequences, especially for women of childbearing age and their future children. Researchers believe that cholestyramine might help the body get rid of these POPs more quickly before surgery, potentially reducing their impact after significant weight loss. The study hopes to make bariatric surgery safer for this group of patients.

At a glance

Status

Recruiting

Phase

Sponsor

Centre Hospitalier Universitaire de Nice

Enrolment target

Start

19 Mar 2025

Estimated completion

19 Jun 2026

Obesity, Abdominal Diabetes Bariatric Surgery Candidate

What is this study about?

You might have heard about certain chemicals in our environment, from things like pesticides and plastics, that can affect our health. Some of these are called 'persistent organic pollutants,' or POPs for short. The problem with POPs is that they can stay in our bodies for a long time, particularly gathering in fatty tissues. For people who are obese, especially women considering weight-loss surgery, this can be a specific concern.

When someone has bariatric surgery and loses a lot of weight quickly, the fat stores shrink, and the POPs stored within that fat can be released into their bloodstream. Previous research has shown that these levels can sometimes be quite high after surgery, and this could potentially have health effects. For women who might have children in the future, it's also important because POPs can pass to a baby during pregnancy or through breast milk, and young children are especially sensitive to these chemicals.

This study is exploring whether a medicine called cholestyramine could help. Cholestyramine is already used for other conditions, but researchers think it might also help the body get rid of POPs more efficiently. The idea is that if women take this medication before their weight-loss surgery, their POP levels might be lower already, meaning less would be released when they start losing weight. This could potentially make bariatric surgery safer and reduce long-term health risks for both mothers and their future babies.

Key takeaways

This study explores a medicine to lower environmental chemicals in obese women.
It aims to make bariatric surgery safer by reducing POPs released during weight loss.
Participation involves taking cholestyramine powder and regular health check-ups.
The study focuses on women of childbearing age due to potential risks to future children.
You can withdraw at any time without affecting your medical care.

Who may be eligible?

This study is looking for women who are 18 to 45 years old and are planning to have weight-loss surgery. Your Body Mass Index (BMI) should be over 40, or over 35 if you have other health issues that surgery could help with. You also need to be using effective contraception to prevent pregnancy during the study.

However, you cannot take part if you are pregnant or breastfeeding, or if you have an allergy to cholestyramine. Also, if you have certain existing health conditions like severe constipation, poorly controlled diabetes (HbA1c over 7%), significant kidney or liver problems, or if you are taking specific medications like anti-vitamin K drugs, digoxin, or levothyroxine, you would not be able to join. Patients who cannot provide their own consent or are already in another medical study would also be excluded.

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 a woman between 18 and 45 years old?
Are you planning to have weight-loss (bariatric) surgery?
Are you currently using effective contraception?
Are you NOT pregnant or breastfeeding?
Do you NOT have a known allergy to cholestyramine or severe chronic constipation?
Have you discussed any chronic medical conditions or current medications with your doctor?

Answer every question to see your result.

What does participation involve?

If you join this study, you would be given cholestyramine powder to take. The study will involve regular visits to the clinic for check-ups and to have blood samples taken. These blood samples will help the doctors measure the levels of POPs in your body and see how the medication is working. You would also have your weight and other health indicators monitored closely. The total duration of your participation in the study, including the medication period and follow-up, would be discussed in detail by the study team, but it's designed to track the changes before and after your bariatric surgery. You'll receive all necessary instructions and support from the study staff.

Potential risks and benefits

Participating in this study might offer the potential benefit of lowering the levels of POPs in your body before your weight-loss surgery, which researchers hope could lead to positive long-term health outcomes. However, like any medication, cholestyramine can have side effects, and some may experience digestive issues like constipation. All potential risks and side effects will be explained to you in detail by the study team. You have the right to withdraw from the study at any time, for any reason, without it affecting your medical care. Your decision to participate or not will be fully respected.

Locations (1)

CHU Nice - Hôpital de l'Archet 2
Verified postcode
Nice, France· Recruiting

Common questions

What are POPs and why are they a concern?

POPs are common environmental chemicals that can build up in body fat. They are a concern because they can be released into your bloodstream after weight-loss surgery and may affect your health, especially for women of childbearing age and their children.

What is cholestyramine?

Cholestyramine is a medication that comes as a powder. The study is investigating if it can help your body get rid of POPs more quickly before weight-loss surgery.

Will taking part in this study change my bariatric surgery plan?

No, the study aims to make your surgery safer by trying to reduce POP levels. Your bariatric surgery plan itself would not be changed as a result of joining this study. You will still have your surgery as planned.

What kind of tests will I have if I join?

You will have regular blood tests to check your POP levels and general health. You'll also have check-ups to monitor your weight and overall well-being.

Can I stop participating in the study if I change my mind?

Yes, absolutely. You are free to withdraw from the study at any time, for any reason, without it affecting your medical care or relationship with your healthcare providers.

How to find out more

Nicolas CHEVALIER

chevalier.n@chu-nice.fr 04 92 03 55 19 Official trial record

Always speak to your GP or specialist before deciding to take part in a study.