跳至主要内容
临床试验/NCT07578597
NCT07578597Enrolling By Invitation不适用

Bariatric Surgery and Consequences for Mother and Baby in Pregnancy - II

Odense University Hospital1 个研究点 分布在 1 个国家目标入组 225 人开始时间: 2025年4月1日最近更新:

试验速览

阶段
不适用
状态
Enrolling By Invitation
入组人数
225
试验地点
1

研究概览

简要总结

Background Bariatric surgery (BS) is an efficient treatment of severe obesity and diseases like female infertility. Almost half of the population having BS are women of reproductive age, and BMI above 35 kg/m2 and infertility even serve as eligibility for surgery. BS improves fertility, however with risk of adverse effects on maternal glucose regulation and fetal growth.

Objective We hypothesize that pregnant women with BS have a higher frequency of both hypo- and hyperglycemia causing abnormal fetal growth, and that Roux-en-Y gastric bypass (RYGB) results in higher risk of hypoglycemia and larger glucose variability than sleeve gastrectomy (SG).

Methods In this prospective, multicenter study, we will include 225 pregnant BMI, age, and parity-matched women from four obstetric departments: 75 with RYGB, 75 with SG and 75 without BS. Data include continuous glucose monitoring, activity tracking, blood sampling, questionnaires, and fetal growth.

Discussion Knowledge on prevalence, clinical significance and treatment of maternal glucose excursions and fetal growth in pregnancy following BS are lacking. This study will help clinicians improve the care of pregnant women with BS and to guide women of reproductive age considering BS.

详细描述

Background Glucose metabolism in pregnancy following bariatric surgery Bariatric surgery (BS) increases fertility and decreases obesity related risks associated with pregnancy such as macrosomia, gestational diabetes mellitus (GDM), and pre-eclampsia (1, 2, 3). However, BS is also associated with alterations to the glucose metabolism (4). These alterations have been shown to be more pronounced following Roux-en-Y gastric bypass (RYGB) compared to sleeve gastrectomy (SG) given that RYGB causes more extensive modifications to the gastro-intestinal system (5). Meals are associated with an exaggerated secretion of insulin, which can cause a mismatch between glucose and insulin levels with a risk of hypoglycemia, also known as post-bariatric hypoglycemia (4, 5). On the other hand, pregnancy is accompanied by a progressively decreasing insulin sensitivity (6), which could counteract the risk of hypoglycemia. Results from the first Bariatric surgery And consequences for Mother and Baby In pregnancy (BAMBI) study showed that hypoglycemia was present in both early and late pregnancy as measured by continuous glucose monitoring (CGM) and mixed meal test (7, 8). Surprisingly, the BAMBI study revealed a two-fold increase in time spent in hyperglycemia during CGM throughout pregnancy and in the postpartum period among pregnant women with RYGB compared to BMI-matched healthy pregnant controls (7). Therefore, identification of women with GDM is important. Oral glucose tolerance testing (OGTT) is not recommended among women with bariatric surgery given the risk of hypoglycemia following the glucose load as well as the lack of validated cut-offs (9). According to our current national guideline, diagnosis of GDM in post-bariatric pregnant women is based on self-monitoring of fasting glucose and glucose 1.5 hour following meals (10). However, as shown for both non-pregnant and pregnant individuals with previous bariatric surgery, nadir glucose appears at about 1.5 hour following meals (5, 8). Thus, we might underestimate the prevalence of gestational diabetes in this population. Given the risks associated with GDM for both the mother and the offspring (11), correctly identifying women with GDM is crucial.

Please see attached figure 1, a schematic overview of different outcomes in pregnancy following bariatric surgery.

Fetal growth During the initial 12 months post-surgery, the body is in a catabolic state characterized by a significant weight loss including both lean and fat body mass (12). As of now, it is recommended to postpone conception at least 12 months after BS in order to reduce the risk of insufficient gestational weight gain (GWG) and thereby restricted fetal growth (9). Small-for-gestational age (SGA) neonates are increased in prevalence following BS (13). Insufficient GWG have been associated with an increased risk of delivering SGA neonates, yet insufficient GWG only account for about half the cases (13, 14). The BAMBI study showed a tendency towards increased time spent in hypoglycemia and decreased time in hyperglycemia among the women with RYGB delivering SGA neonates as compared to the women with RYGB delivering appropriate-for-gestational age (AGA) neonates. Additionally, women with RYGB delivering large-for-gestational (LGA) neonates spent less time in hypoglycemia and more time in hyperglycemia as compared to the women with RYGB delivering AGA neonates (8). Unfortunately, the BAMBI study lacked power to show a statistical significant difference.

In Denmark, female infertility and BMI >35kg/m2 serve as eligibility criteria for BS (15). About 40% of people having BS are women of childbearing age, both nationally and internationally (16, 17). The number of bariatric surgeries performed among women of childbearing age have been increasing since 2015, and 890 women had bariatric surgery in Denmark in 2022 (16). Therefore, studies comparing RYGB and SG are needed to guide the women to the best possible pregnancy outcome when having BS before pregnancy.

Aims

研究设计

研究类型
Interventional
分配方式
Non Randomized
干预模型
Parallel
主要目的
Diagnostic
盲法
None

入排标准

年龄范围
18 Years 至 —(Adult, Older Adult)
性别
Female
接受健康志愿者

入选标准

  • RYGB group: pregnant women with RYGB and their neonate (n = 75)
  • SG group: pregnant women with SG and their neonate (n = 75)
  • non-BS group: pregnant women without BS matched on age, pre-pregnancy-BMI and parity and their neonate (n = 75)

排除标准

  • multiple pregnancy
  • age below 18 and above 45 years
  • ongoing smoking or substance abuse
  • severe psychiatric disorder or chronic disease
  • use of GLP-1 analogue within two months of conception
  • women with overt diabetes at inclusion (HbA1c ≥ 48 mmol/l and/or fasting p-glucose ≥ 7 mmol/l)
  • women with pre-gestational diabetes (type1 or 2) prior to RYGB
  • women with GDM in a previous pregnancy will not be excluded

研究者

申办方类型
Other
责任方
Principal Investigator
主要研究者

Louise Brügmann Jessen

MD

Odense University Hospital

研究点 (1)

Loading locations...

相似试验