Recruiting NA Obesity, Abdominal

New treatment option for Obesity, Abdominal

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

ClinicalTrials.gov ID: NCT05966727

What this study is testing

What is Cholestyramine Powder?

Cholestyramine Powder is an investigational medicine, given as an once-daily, being studied as a potential treatment for obesity, abdominal.

Also referred to as Questran.

Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.

What it's testing
Environmental endocrine disruptors (EDCs) represent a major problem for human health.Some PEEs can accumulate in the fatty tissue of the human body thanks to their lipophilic nature, and are known as persistent organic pollutants (POPs). To assess the benefit of cholestyramine treatment on POPs blood levels in obese patients of childbearing age undergoing bariatric surgery, in order to reduce their preoperative POPs load more rapidly.

A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.

Who can take part

Ages 18 to 45, women only

You may be able to join if

  • Female patients with a retained indication for bariatric surgery (BMI \> 40 kg/m2 or BMI \> 35 kg/m2 with complication(s) amenable to improvement by...
  • Aged between 18 and 45
  • Using effective contraception (oral contraception, hormonal or non-hormonal intrauterine device, progestin implant), which will be adapted in the...
  • Affiliated to a social security scheme
  • Have signed an informed consent form

You likely can't join if

  • Pregnant (urine pregnancy test) or breast-feeding women
  • Known allergy or intolerance to cholestyramine
  • Chronic constipation
  • Chronic pathology likely to interfere with treatment how well it works (unbalanced diabetes characterized by HbA1c \> 7%, known and treated...
  • Patients receiving anti-vitamin K, digoxin or levothyroxine therapy, or likely to receive such therapy within 3 months of inclusion.
  • Phenylketonuria
See the full eligibility criteria
Who can join
  • Female patients with a retained indication for bariatric surgery (BMI \> 40 kg/m2 or BMI \> 35 kg/m2 with complication(s) amenable to improvement by surgery)
  • Aged between 18 and 45
  • Using effective contraception (oral contraception, hormonal or non-hormonal intrauterine device, progestin implant), which will be adapted in the perioperative period in accordance with current recommendations (HAS...
  • Affiliated to a social security scheme
  • Have signed an informed consent form
What rules you out
  • Pregnant (urine pregnancy test) or breast-feeding women
  • Known allergy or intolerance to cholestyramine
  • Chronic constipation
  • Chronic pathology likely to interfere with treatment how well it works (unbalanced diabetes characterized by HbA1c \> 7%, known and treated dyslipidemia, chronic renal insufficiency with GFR \< 60 ml/min, hepatocellular...
  • Patients receiving anti-vitamin K, digoxin or levothyroxine therapy, or likely to receive such therapy within 3 months of inclusion.
  • Phenylketonuria
  • Inability to give consent
  • Patient under legal protection (guardianship, curatorship, safeguard of justice...)
  • Patient deprived of liberty by judicial or administrative decision,
  • Patients under psychiatric care which makes it impossible for them to consent to participation, or who are hospitalized under duress.
  • Participation in another treatment study (outside the PaCO project).

The study team makes the final eligibility decision.

Where it's taking place

  • Nice, Alpes-Mritimes, France

Questions & answers

Do participants get paid in this trial?

This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.

Is it free to join, and do I need insurance?

Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.

How long does this study last?

The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.

Who can join this trial?

This study is enrolling female, 18 years to 45 years. The study team makes the final eligibility decision.

Where is this trial taking place?

Study sites include Nice, Alpes-Mritimes, France. Enter your location above to see the nearest site and check your eligibility.

Explore other conditions

BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.