NCT06067906Recruiting
Weight Loss Following an Episode of Pre-eclampsia Using a Dissociated or Hypocaloric Diet in Overweight or Obese Patients
Source: ClinicalTrials.gov · Last updated 28 Aug 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
In view of the known link between pre-eclampsia, overweight/obesity and chronic kidney disease, the aim is to offer for obese and overweight patients to reduce their BMI without reducing lean body mass. The POPADIPE project will make it possible to limit overweight or obesity by means of nutritional management chosen by the patient (hypocaloric or a dissociated diet). The latter has been the subject of little scientific investigation, particularly in relation to the management of post-pre-eclampsia.
- Status (registry)
- Recruiting
- Study type
- Interventional
- Enrollment
- 60 (estimated)
- First submitted
- 28 Sept 2023
- Start date
- Nov 2023
- Primary completion date
- Nov 2028
- Lead sponsor
- Centre Hospitalier le Mans
- Diseases
- Obesity
- NCT number
- NCT06067906
What you commit to
- Study type: Interventional
- Planned participants: 60
- From Nov 2023 to the primary completion date, Nov 2028
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Patients undergoing steroid treatment and/or immunosuppression
Other illness
- Patients under psychiatric care
- Patients with cognitive disorders or defined eating disorders
Other
- Patients with a mental disability or language barrier that prevents them from understanding or consenting to the study
- Patients deprived of their liberty by judicial or administrative decision
- Patients subject to a legal protection measure
- Patients who are pregnant or breast-feeding
- Have been on a low-calorie or dissociated diet for at least 6 months
- Patients with CKD stage ≥ 3A
Who the study is looking for
- Person affiliated to social security
- Free, informed and written consent signed by the participant and the investigator (no later than the day of day of inclusion and before any examination required by the research)
- Patient over 18 years of age at the time of inclusion and \< 45 years of age
- Having had an pre-eclampsia in the last 5 years according to the definitions of the ISSHP 2018
- Patient with a BMI between 25 kg/m² and 40 kg/m² who accepts dietetic follow up
- Patient with a medical prescription for dietetic follow-up aimed at losing weight loss
- Patient with a balanced diet
Age in the registry: 18 years to 45 years · Sex: Female · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Centre Hospitalier du Mans Coordinator of this site? Confirm its status | Le Mans | France | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.