Determinant of Fetal Growth Retardation After Sleeve Gastrectomy: Involvement of Ghrelin

Sleeve Gastrectomy Clinical Trial

— FG-SLEEVE  

Official title:

Determinant of Fetal Growth Retardation After Sleeve Gastrectomy: Involvement of Ghrelin

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT05977790
• Other study ID #: APHP220714
• Status: Recruiting
• Start date: July 10, 2023
• Est. completion date: July 2025

Study information

• Verified date: August 2023
• Source: Assistance Publique - Hôpitaux de Paris
• Contact: Séverine Ledoux, MD
• Phone: 01 47 60 62 50
• Email: severine.ledoux[@]aphp.fr
• Is FDA regulated: No
• Study type: Observational

Clinical Trial Summary

The aim of the study is to determine, in pregnant women who have undergone sleeve gastrectomy (SG), whether ghrelin changes could be involved in in utero growth restriction (IUGR) and whether therefore a correlation between maternal ghrelin levels and birth weight is observed.

Description:

Bariatric surgery (BS) has developed rapidly in recent years and the candidates are predominantly women of childbearing age. A negative impact on fetal growth (FG), has been described after BS whose mechanisms are not elucidated. The sleeve gastrectomy (SG), the most commonly practiced BS technique, is supposed to induce fewer nutritional deficiencies than gastric bypass. This is why it seems to be the technique of choice for young women, although the lack of hindsight does not allow recommendations to be made. However, latest work showed that birth weight (BW) was affected as much after SG as after RYGB (Roux-en-Y Gastric Bypass), with 50% of BW Z-score <0 and 19% of small newborns for gestational age. In addition, only weight gain during pregnancy and maternal protein status were related to BW, but these parameters explained only 16% and 8% of the variance of the BW Z-score, respectively, suggesting that other factors are therefore involved. Sleeve gastrectomy induces the loss of the majority of gastric cells secreting ghrelin, an orexigenic hormone involved in the regulation of appetite but also in the pituitary secretion of growth hormone, which could influence fetal growth, as shown in a model of pregnant rats. However, no studies have evaluated the link between maternal ghrelin and pregnancy outcome in women undergoing bariatric surgery. The study population will include pregnant women who have undergone bariatric surgery such as sleeve gastrectomy (which is currently the most frequently performed technique) before pregnancy, coming to consult between the 3rd and 6th month of pregnancy (2nd trimester) for a nutritional check-up in a day hospital.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 50
• Est. completion date: July 2025
• Est. primary completion date: January 2025
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Woman previously operated of sleeve gastrectomy
• Pregnant from 3 to 6 months
• Having a mono-fetal pregnancy
• Coming to consult in day hospital for a nutritional assessment

Exclusion Criteria:

• Twin pregnancy
• Identified cause of IUGR apart from those related to sleeve gastrectomy
• Woman who has undergone another bariatric surgery technique
• Lack of individual information and collection of the consent form
• Problems of understanding
• Lack of affiliation to a social security scheme or state medical aid
• Patient benefiting from a legal protection measure (with guardians or curators)

Related Conditions & MeSH terms

• Fetal Growth Retardation
• Pregnancy Complications
• Sleeve Gastrectomy

Locations

Country	Name	City	State
France	Hopital Louis Mourier	Colombes

Sponsors (1)

Lead Sponsor	Collaborator
Assistance Publique - Hôpitaux de Paris

Country where clinical trial is conducted

France, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Correlation between ghrelin levels and birth weight of children born to mothers who had a sleeve gastrectomy	Fasting blood ghrelin level measured in plasma by radioimmunoassay technique in the second trimester of pregnancy. The dosages will be carried out deferred after freezing at -80 ° C in a laboratory, in order to be able to dose all the samples at the same time and limit the variability of the results.	18 months
Secondary	Nutritional factors that may influence birth weight after sleeve gastrectomy	These parameters will be collected between the 3rd and 6th month of pregnancy and childbirth.; Parameters collected : parity, tobacco, alcohol, current treatment, vitamin supplementation, weight and BMI before sleeve, weight loss after sleeve, weight gain during the visit, caloric intake during the visit, number and type of nutritional deficiencies, total weight gain during pregnancy.	18 months
Secondary	Obstetric factors that may influence birth weight after sleeve gastrectomy	These parameters will be collected between the 3rd and 6th month of pregnancy and childbirth.; Parameters collected : term at time of analysis, time since sleeve, term of pregnancy at birth, sex of child, PN Z-score, complications of pregnancy or birth	18 months
Secondary	Nutritional factors that may interact with the effect of ghrelin	These parameters will be collected between the 3rd and 6th month of pregnancy and childbirth.; Parameters collected : parity, tobacco, alcohol, current treatment, vitamin supplementation, weight and BMI before sleeve, weight loss after sleeve, weight gain during the visit, caloric intake during the visit, number and type of nutritional deficiencies, total weight gain during pregnancy.	18 months
Secondary	Obstetric factors that may interact with the effect of ghrelin	These parameters will be collected between the 3rd and 6th month of pregnancy and childbirth.; Parameters collected : term at time of analysis, time since sleeve, term of pregnancy at birth, sex of child, PN Z-score, complications of pregnancy or birth	18 months