Glucose Homeostasis, Metabolomics and Pregnancy Outcomes After Bariatric Surgery
Ориентир для пациента и семьи
Простыми словами
Автоматическая сводка по структурированным данным реестра. Она помогает сориентироваться, но не заменяет официальный протокол или оценку врача.
- Что изучают
- В протоколе указаны: CGM.
- Кому может быть актуально
- Состояния в реестре: Bariatric Surgery Status Complicating Pregnancy. Базовые параметры: 18 лет — 45 лет · Женщины.
- Что важно проверить
- Возраст, диагноз и пол — только базовые ориентиры. Предыдущее лечение, анализы и другие обязательные условия указаны ниже в критериях участия.
- Где проводится
- Бельгия
- Следующий шаг
- Сохраните исследование, покажите его лечащему врачу и уточните актуальный статус у исследовательского центра. Расходы, документы и поездка →
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Обзор
The aim of the GLORIA study is to determine whether an altered glucose metabolism (with more hypoglycaemia and glycaemic variability) and altered metabolomics during pregnancy after bariatric surgery contribute to the increased risk for adverse pregnancy outcomes such as small-for-gestational age infants. In addition, the investigators also aim to evaluate whether continuous glucose monitoring (CGM) can be used to diagnose gestational diabetes (GDM).
Подробное описание
The GLORIA study is a Belgian multicenter prospective cohort study. The investigators aim to recruit 95 pregnant women after bariatric surgery (gastric bypass or sleeve gastrectomy) and as a control group, an age and BMI-matched cohort of 95 pregnant women without bariatric surgery. Participants will be recruited before 12 weeks of pregnancy. To evaluate glucose homeostasis, a masked CGM will be used for 10 days during each trimester in pregnancy and at the time of screening for GDM (at 24-28 weeks). The primary outcome is the mean glycaemia levels and glycaemic variability (SD) measured by CGM in pregnancy. At the different time points, anthropometric measurements (including body composition), food diary, questionnaires and micronutrients will be evaluated. In addition, in collaboration with the lab of Cristina Legido Quigle from the Steno Diabetes Center in Copenhagen, metabolomics will be analyzed. Women with a history of bariatric surgery will receive screening for GDM between 24-28 weeks of pregnancy by performing self- monitoring of blood glucose (SMBG) with a glucometer during one week. In addition to SMBG, women will receive a masked CGM during one week.
Вмешательства
- Диагностический тест CGM
blinded CGM used at 4 different time points in pregnancy
Первичные конечные точки
- mean glycaemia [Срок оценки: between 6-12 weeks of pregnancy, 18-22 weeks of pregnancy, 24-28 weeks of pregnancy and 30-34 weeks of pregnancy]
- Standard deviation of glycaemia [Срок оценки: between 6-12 weeks of pregnancy, 18-22 weeks of pregnancy, 24-28 weeks of pregnancy and 30-34 weeks of pregnancy]
Вторичные конечные точки (12)
- time <54mg/dl [Срок оценки: between 6-12 weeks of pregnancy, 18-22 weeks of pregnancy, 24-28 weeks of pregnancy and 30-34 weeks of pregnancy]
- glycaemic variability measured by coefficient of variation (CV) [Срок оценки: between 6-12 weeks of pregnancy, 18-22 weeks of pregnancy, 24-28 weeks of pregnancy and 30-34 weeks of pregnancy]
- glycaemic variability measured by mean amplitude of glucose excursions (MAGE) [Срок оценки: between 6-12 weeks of pregnancy, 18-22 weeks of pregnancy, 24-28 weeks of pregnancy and 30-34 weeks of pregnancy]
- time <70mg/dl [Срок оценки: between 6-12 weeks of pregnancy, 18-22 weeks of pregnancy, 24-28 weeks of pregnancy and 30-34 weeks of pregnancy]
- time <63mg/dl [Срок оценки: between 6-12 weeks of pregnancy, 18-22 weeks of pregnancy, 24-28 weeks of pregnancy and 30-34 weeks of pregnancy]
- time <50mg/dl [Срок оценки: between 6-12 weeks of pregnancy, 18-22 weeks of pregnancy, 24-28 weeks of pregnancy and 30-34 weeks of pregnancy]
- low blood glucose index (LBGI) [Срок оценки: between 6-12 weeks of pregnancy, 18-22 weeks of pregnancy, 24-28 weeks of pregnancy and 30-34 weeks of pregnancy]
- time > 120mg/dl [Срок оценки: between 6-12 weeks of pregnancy, 18-22 weeks of pregnancy, 24-28 weeks of pregnancy and 30-34 weeks of pregnancy]
- time > 140mg/dl [Срок оценки: between 6-12 weeks of pregnancy, 18-22 weeks of pregnancy, 24-28 weeks of pregnancy and 30-34 weeks of pregnancy]
- time > 180mg/dl [Срок оценки: between 6-12 weeks of pregnancy, 18-22 weeks of pregnancy, 24-28 weeks of pregnancy and 30-34 weeks of pregnancy]
- prevalence of gestational diabetes [Срок оценки: 24-28 weeks of pregnancy]
- gestational weight gain [Срок оценки: at end of pregnancy]
Критерии участия
Критерии включения
- Age 18-45 years and with a singleton pregnancy with ultrasound-confirmed gestational age up to 11 weeks and 6 days
- for the group with bariatric surgery: history of gastric bypass (RYBG) or sleeve gastrectomy (SG)
- Participants need to speak and understand Flemish, French or English and have e-mail access.
Критерии исключения
- multiple pregnancy
- pregnancy ≥12 weeks
- other types of bariatric surgery than RYBG or SG
- known pregestational diabetes
- a physical or psychological disease likely to interfere with the conduct of the study
- medications known to interfere with glucose metabolism.
Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.
Здоровые добровольцы: Да
Дизайн исследования
- Модель наблюдения
- Когортное
Центры проведения
Бельгия · 8 центров
- OLV-Aalst-Asse — Aalst
- UZA — Antwerp
- ZNA Antwerpen — Antwerp
- Imelda Bonheiden — Bonheiden
- AZ St-Jan Brugge — Bruges
- UZ Gent — Ghent
- AZ Groeninge Kortrijk — Kortrijk
- UZ Leuven — Leuven
Публикации
- Deleus E, Bochanen N, Ceulemans D, Debunne H, Denys B, Devlieger R, Geerts I, Laenen A, Jochems L, Lannoey E, Lannoo M, Loccufier A, Maes T, Marlier J, Morrens A, Myngheer N, Tierens L, Vandenberghe G, Van den Bruel A, Van den Haute L, Van der Schueren B, Van Pottelbergh I, Benhalima K. Glucose Homeostasis, Metabolomics, and Pregnancy Outcomes After Bariatric Surgery (GLORIA): Protocol for a Multi PMID 40649156
Идентификаторы
NCT: NCT05084339 · S65734