Recruiting

NCT Number: NCT06067906

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

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.

Recruiting

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Key information

Conditions

Pre-eclampsia Body Weight Female Urogenital Diseases and Pregnancy Complications Hypertension, Pregnancy-Induced Nutrition Disorders Nutritional and Metabolic Diseases Obesity Overnutrition Overweight Pathological Conditions, Signs and Symptoms Pregnancy Complications Signs and Symptoms Urogenital Diseases

Age range

18 year–45 year

Sex eligibility

Female

Study type

Interventional

Phase

Not applicable

Primary location

Centre Hospitalier Du Mans

Le Mans, 72000, France

Location status: Recruiting

Location contact

Christelle JADEAU

CONTACT

[email protected]

+33244710781

Coralie BARDOU

SUB_INVESTIGATOR

Françoise LIPPI

PRINCIPAL_INVESTIGATOR

Jérôme VIGREUX

SUB_INVESTIGATOR

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Hypocaloric diet

Other

Hypocaloric diet

Dissociated diet

Other

Dissociated diet

Primary outcomes

Demonstrate Efficiency of personalised dietary management on weight loss in patients with a history of pre-eclampsia

Time frame: 1 year after care

Efficiency is evaluated by weight measurement

Sponsors and collaborators

Lead sponsor

Centre Hospitalier le Mans

Other

Registry information

Acronym: POPADIPE

Important dates

Study start: 2023
Primary completion: 2028
Study completion: 2028
First posted: Oct 5, 2023
Registry last updated: Aug 28, 2024

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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