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Recruiting Not applicable

Weight Loss Following an Episode of Pre-eclampsia Using a Dissociated or Hypocaloric Diet in Overweight or Obese Patients

NCT06067906 · tracked via the Priya Life Science France tracker
Phase
Not applicable
Started
2023-11-02
Last updated
2024-08-28

Condition(s) studied

Pre-EclampsiaObesity

Investigational drug(s) / intervention(s)

Hypocaloric dietDissociated diet

Hypocaloric diet: Hypocaloric diet

Dissociated diet: Dissociated diet

Study 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

Sex
FEMALE
Min age
18 Years
Max age
45 Years
Healthy volunteers
No
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

Primary outcome measure(s)

  • Demonstrate Efficiency of personalised dietary management on weight loss in patients with a history of pre-eclampsia — 1 year after care
    Efficiency is evaluated by weight measurement

Trial sites (1)

FacilityCityRegionStatus
Centre Hospitalier Du Mans Le Mans France Recruiting
Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT06067906 on ClinicalTrials.gov ↗ ← All trials in France