Study on the Effect of Cholestyramine on Pollutant Levels in Obese Women Eligible for Bariatric Surgery

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What is this study about?

This clinical trial is focused on studying the effects of a medication called cholestyramine on certain chemicals in the blood known as persistent organic pollutants. These pollutants can remain in the environment and the body for a long time. The study is specifically looking at women who are dealing with obesity and are planning to undergo weight-loss surgery, also known as bariatric surgery. The purpose of the study is to see how cholestyramine affects the levels of these pollutants in the blood before and after the surgery.

Participants in the study will take cholestyramine, which is a type of medication that comes in a powder form and is mixed with water to drink. The study will compare the levels of persistent organic pollutants in the blood before the surgery and four months after the surgery. This will help researchers understand if cholestyramine can help reduce these pollutants in the body.

The study will last until June 2025, and it aims to provide valuable information on how cholestyramine might help manage the levels of persistent organic pollutants in people with obesity who are undergoing bariatric surgery. This research could potentially lead to better health outcomes for individuals dealing with obesity and related health issues.

1 joining the study

Upon joining the study, you will be informed about the purpose and procedures involved. You will be asked to provide consent to participate in the trial.

2 initial assessment

An initial assessment will be conducted to confirm your eligibility. This includes verifying that you are a female aged between 18 and 45 years, with a body mass index (BMI) greater than 40 kg/m² or greater than 35 kg/m² with complications that can be improved by surgery. You must also have effective contraception in place.

3 pre-surgery evaluation

Before the surgery, your blood will be tested to measure the levels of persistent organic pollutants. This is referred to as the M0 (pre-surgery) measurement.

4 medication administration

You will be given a medication called Questran, which contains the active substance colestyramine. This medication is provided as a powder to be mixed with water and taken orally. The dosage and frequency will be specified by the study team.

5 post-surgery evaluation

After the surgery, another blood test will be conducted to measure the levels of persistent organic pollutants. This is referred to as the M4 (post-surgery) measurement.

6 follow-up and conclusion

The study will continue to monitor your health and the levels of pollutants in your blood. The trial is expected to conclude by June 1, 2025.

Who Can Join the Study?

Must be a female patient.
Must have an accepted indication for bariatric surgery. This means having a Body Mass Index (BMI) greater than 40 kg/m², or a BMI greater than 35 kg/m² with health problems that can be improved by surgery.
Must be aged between 18 and 45 years.
Must use effective contraception. This includes methods like oral contraception (the pill), a hormonal or non-hormonal intrauterine device (IUD), or a progestin implant. These methods may need to be adjusted around the time of surgery according to current guidelines.

Who Cannot Join the Study?

Men cannot participate in the study. Only women are eligible.
Women who are not of childbearing age cannot participate. The study is for women who can have children.
Women who do not have obesity cannot participate. The study is for women with obesity.
Women who are not candidates for bariatric surgery cannot participate. Bariatric surgery is a type of surgery to help with weight loss.

Where you can join this trial?

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Other Sites

Site Name	City	Country	Status
Centre Hospitalier Universitaire De Nice	Nice	France

Trial status

Country	Status	Recruitment Start
France	Recruiting	01.06.2023

Trial locations

Investigated drugs:

Colestyramine

Cholestyramine is a medication used in this clinical trial. It works by binding to certain substances in the intestines, which helps to remove them from the body. In this study, cholestyramine is being tested to see if it can lower the levels of certain harmful chemicals, known as persistent organic pollutants, in the blood of obese women who are considering weight-loss surgery. These pollutants can build up in the body over time and may have negative health effects. The goal of using cholestyramine in this trial is to see if it can help reduce these pollutants and potentially improve the health of the participants.

Investigated diseases:

Epidermolysis bullosa

Obesity – Obesity is a condition characterized by excessive body fat accumulation that may impair health. It develops when there is an imbalance between calories consumed and calories expended, leading to energy storage in the form of fat. Over time, this excess fat can accumulate in various parts of the body, including under the skin and around internal organs. The progression of obesity can lead to increased body mass index (BMI) and changes in body shape and size. As obesity progresses, it can contribute to the development of other health issues, such as joint problems and metabolic disturbances. The condition is influenced by a combination of genetic, environmental, and lifestyle factors.

Trial ID:

2023-505116-37-00

Protocol code:

21-AOI-07

Trial Phase:

Therapeutic exploratory (Phase II)

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Study on the Effect of Cholestyramine on Pollutant Levels in Obese Women Eligible for Bariatric Surgery

What is this study about?

Who Can Join the Study?

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