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

C

Centre Hospitalier le Mans

Status

Enrolling

Conditions

Pre-Eclampsia
Obesity

Treatments

Other: Hypocaloric diet
Other: Dissociated diet

Study type

Interventional

Funder types

Other

Identifiers

NCT06067906
CHM-2022/S08/12

Details and patient eligibility

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.

Enrollment

60 estimated patients

Sex

Female

Ages

18 to 45 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Supportive Care

Allocation

Non-Randomized

Interventional model

Parallel Assignment

Masking

None (Open label)

60 participants in 2 patient groups, including a placebo group

control group
Placebo Comparator group
Treatment:
Other: Hypocaloric diet
innovative group
Experimental group
Treatment:
Other: Dissociated diet

Trial contacts and locations

1

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Data sourced from clinicaltrials.gov

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