Weight Loss Following an Episode of Pre-eclampsia Using a Dissociated or Hypocaloric Diet in Overweight or Obese Patients
Recruiting · NCT06067906 · Interventional (participants receive a specific treatment) · Lead sponsor: Centre Hospitalier le Mans
View the official record on ClinicalTrials.gov →Interventions studied
Dissociated dietHypocaloric diet
What this trial is about
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.
Who can take part
Age range
18 Years to 45 Years
Sex
Female
Healthy volunteers
No - a diagnosis or condition is required
Phase
Not applicable (e.g. observational or device study)
Study type
Interventional (participants receive a specific treatment)
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
Where it is running
2 locations listed.
- Centre Hospitalier Du Mans - Le Mans, France
- Centre Hospitalier Du Mans - Le Mans, France