Pre-EclampsiaPOPADIPENCT06067906
Weight Loss Following an Episode of Pre-eclampsia Using a Dissociated or Hypocaloric Diet in Overweight or Obese Patients
A study testing Hypocaloric diet and Dissociated diet in people with Pre-Eclampsia and Obesity, run by Centre Hospitalier le Mans at 1 site in France.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women only
- Conditions the study is for
- Pre-Eclampsia, Obesity
- What is being tested?
- Hypocaloric diet and Dissociated diet
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 1 siteFrance
- Study dates
- 2 Nov 2023to 2 Nov 2028
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- No healthy volunteers
- Adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 9Show fewer
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
France1 site, 1 recruiting
- Recruiting
Centre Hospitalier Du Mans
Le Mans, 72000
Christelle JADEAU, +33244710781, cjadeau@ch-lemans.fr
Françoise LIPPI
About this study
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.
- Conditions
- Pre-Eclampsia, Obesity
- Being tested
- Hypocaloric diet, Dissociated diet
- Keywords
- pre-eclampsia, obesity, dissociated diet
- Medical subject headings
- Pre-Eclampsia, Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Hypocaloric dietOther
Hypocaloric diet
Dissociated dietOther
Dissociated diet
| Study group | Role | What they receive |
|---|---|---|
| control group | Placebo comparator | Not described Receives: Other: Hypocaloric diet |
| innovative group | Experimental | Not described Receives: Other: Dissociated diet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Demonstrate Efficiency of personalised dietary management on weight loss in patients with a history of pre-eclampsia
Efficiency is evaluated by weight measurement
Measured: 1 year after care
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted5 Oct 2023
- Study start2 Nov 2023
- Primary completion2 Nov 2028 (estimated)
- Study completion2 Nov 2028 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Pre-EclampsiaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Centre Hospitalier le Mans
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06067906
- Sponsor's protocol ID
- CHM-2022/S08/12
- Acronym
- POPADIPE
- Status last verified
- Aug 2024
- First submitted
- 28 Sep 2023
- Last updated
- 28 Aug 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Weight Loss Following an Episode of Pre-eclampsia Using a Dissociated or Hypocaloric Diet in Overweight or Obese Patients
- ClinicalTrials.gov ID
- NCT06067906
- Acronym / sponsor ID
- POPADIPE / CHM-2022/S08/12
- Conditions
- Pre-Eclampsia, Obesity
- Keywords
- pre-eclampsia, obesity, dissociated diet
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Centre Hospitalier le MansUniversity, hospital or other
- Study start
- 2 Nov 2023 (actual)
- Primary completion
- 2 Nov 2028 (estimated)
- Study completion
- 2 Nov 2028 (estimated)
- First posted
- 5 Oct 2023 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Supportive care
- Allocation
- Non-randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| control group | Placebo comparator | Other: Hypocaloric diet |
| innovative group | Experimental | Other: Dissociated diet |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (9 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Hypocaloric dietHypocaloric diet | Other | control group |
| Dissociated dietDissociated diet | Other | innovative group |
Primary outcome
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
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2024.
- Individual participant dataSharing planned: No
Related trials for Pre-Eclampsia
Recruiting
Exercise to Improve Heart and Metabolic Health After Childbirth in Women at High Risk for Preeclampsia
Postpartum Exercise, Cardiometabolic Health
RecruitingObservational study
Molecular Study of the Maternal-fetal Interface in Preeclampsia.
Preeclampsia
Active, not recruitingObservational study
The CoPenHagen PREeClampsia and cardIOvascUlar diSease Study
Pre-Eclampsia, Atherosclerosis
RecruitingObservational study
Estimated Risk of Preeclampsia in the First Trimester and Its Association With Subclinical Atherosclerosis and Cardiovascular Risk in Women With Type 1 Diabetes
Type 1 Diabetes, Preeclampsia
Not yet recruitingPhase 2
Furosemide vs Placebo in Severe Preeclampsia Postpartum
Severe Preeclampsia
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Hypocaloric diet and Dissociated diet in people with Pre-Eclampsia and Obesity, run by Centre Hospitalier le Mans at 1 site in France.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 28 Aug 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in France. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Each site lists its own contact: choose the nearest one under Trial locations. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Demonstrate Efficiency of personalised dietary management on weight loss in patients with a history of pre-eclampsia (time frame: 1 year after care). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Aug 2024.