NCT06067906 Weight Loss Following an Episode of Pre-eclampsia Using a Dissociated or Hypocaloric Diet in Overweight or Obese Patients
| NCT ID | NCT06067906 |
| Status | Recruiting |
| Phase | — |
| Sponsor | Centre Hospitalier le Mans |
| Condition | Pre-Eclampsia |
| Study Type | INTERVENTIONAL |
| Enrollment | 60 participants |
| Start Date | 2023-11-02 |
| Primary Completion | 2028-11-02 |
Eligibility & Interventions
Eligibility Fast-Check
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What to Expect as a Participant
You will actively receive the study intervention — which may be a drug, biologic, device, or procedure.
This trial targets 60 participants in total. It began in 2023-11-02 with a primary completion date of 2028-11-02.
⚠ This information is for research awareness only. Always consult your physician before joining any clinical trial. Participation is voluntary and you may withdraw at any time.
Brief Summary
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.
Eligibility Criteria
Inclusion Criteria: * 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 Exclusion Criteria: * 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 under psychiatric care * Patients subject to a legal protection measure * Patients with cognitive disorders or defined eating disorders * Patients who are pregnant or breast-feeding * Patients undergoing steroid treatment and/or immunosuppression * Have been on a low-calorie or dissociated diet for at least 6 months * Patients with CKD stage ≥ 3A
Frequently Asked Questions
Who can join the NCT06067906 clinical trial?
This trial is open to female participants only, aged 18 Years or older, up to 45 Years, studying Pre-Eclampsia. Full inclusion and exclusion criteria are listed in the Eligibility Criteria section. Always confirm your eligibility with the research team before applying.
Is NCT06067906 currently recruiting?
Yes, NCT06067906 is actively recruiting participants. Visit ClinicalTrials.gov or contact Centre Hospitalier le Mans to inquire about joining.
Where is the NCT06067906 trial being conducted?
This trial is being conducted at Le Mans, France.
Who is sponsoring the NCT06067906 clinical trial?
NCT06067906 is sponsored by Centre Hospitalier le Mans. The trial plans to enroll 60 participants.