Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-25 @ 2:20 AM
Ignite Modification Date:
2025-12-25 @ 2:20 AM
NCT ID:
NCT04642534
Brief Summary:
For women of reproductive age, the overall postpartum weight retention (weight gain between pregnancies) plays a significant role in long-term obesity. With 20% of women retaining ≥ 5 kg at 12 months postpartum, the risk of developing conditions, such as gestational diabetes mellitus (GDM), metabolic syndrome (MS) and subsequently diabetes and cardiovascular diseases, is substantially increased. In post-GDM mothers (women who had GDM in their recent pregnancy), postpartum weight retention is also an essential predictor of future diabetes.
Recent studies have identified the impact of circadian rhythms (influencing sleep/wake cycles) and diurnal rhythm of eating (when and how often calories are consumed over a 24h period) on cardio-metabolic disorders. In women, one remarkable feature of the postpartum period is an 'externally imposed' circadian misalignment of both sleep and eating rhythms, because most babies take several weeks to months to establish their daily pattern of activity and feeding, which is particularly relevant for breastfeeding women, as the responsibility is generally on the mother.
The overarching goal of this project is to explore the interplay between the diurnal rhythm of eating, circadian and metabolic parameters in humans. The potential postpartum effects of circadian disruption will be unraveled in women who had GDM during their pregnancy and those with an uneventful pregnancy. These women are subject to a circadian misalignment due to their 'externally imposed' changes in sleep/wake cycles and eating times in the postpartum period.
With a comprehensive approach combining molecular characterization of in vivo and in vitro circadian clock parameters along with metabolic, endocrine, transcriptomic, and lipidomic studies, the investigators will assess if eating duration and/or circadian misalignment impact on circadian clock parameters of postpartum women in a prospective cohort of 6 months.
Study:
NCT04642534
Study Brief:
Protocol Section:
NCT04642534