Circadian Clocks and Eating Patterns (Cohort)

Overview

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.

Full Title of Study: “Molecular and Functional Interplay Between the Circadian Clocks and Eating Patterns in Patients With Cardio-metabolic Diseases (Cohort)”

Study Type

  • Study Type: Observational
  • Study Design
    • Time Perspective: Prospective
  • Study Primary Completion Date: February 28, 2022

Arms, Groups and Cohorts

  • Postpartum women who had gestational diabetes mellitus
    • Inclusion at 4-8 weeks postpartum Follow-up for 6 months
  • Postpartum women after an uneventful pregnancy
    • Inclusion at 4-8 weeks postpartum Follow-up for 6 months

Clinical Trial Outcome Measures

Primary Measures

  • Eating duration
    • Time Frame: Changes between baseline and the close-out visit (i.e. changes between Month 0 and Month 6)
    • Duration from the first to last caloric intake over 24-hour cycle
  • Correlation of in vitro circadian parameters (amplitude and magnitude) with clinical metabolic health outcomes (body weight)
    • Time Frame: At baseline
    • Measured in cultured skin fibroblasts

Secondary Measures

  • Sleep/wake cycles
    • Time Frame: Changes between baseline and the close-out visit (i.e. changes between Month 0 and Month 6)
    • Measured by actigraphy
  • Sleep/wake cycles
    • Time Frame: Changes between baseline and the close-out visit (i.e. changes between Month 0 and Month 6)
    • Measured by the Pittsburgh Sleep Quality Index (scale 0-21, 0 indicating no sleeping difficulty, 21 indicating severe sleeping difficulties)
  • Body weight
    • Time Frame: Changes between baseline and the close-out visit (i.e. changes between Month 0 and Month 6)
    • Measured by bioelectrical impedance analysis
  • Fat mass
    • Time Frame: Changes between baseline and the close-out visit (i.e.changes between Month 0 and Month 6)
    • Measured by bioelectrical impedance analysis
  • Fat-free mass
    • Time Frame: Changes between baseline and the close-out visit (i.e. changes between Month 0 and Month 6)
    • Measured by bioelectrical impedance analysis
  • Physical activity (activity count per minute)
    • Time Frame: Changes between baseline and the close-out visit (i.e. changes between Month 0 and Month 6)
    • Measured by actigraphy
  • Fasting glucose
    • Time Frame: Changes between baseline and the close-out visit (i.e. changes between Month 0 and Month 6)
    • Measured by clinical chemistry
  • Lipid profile (concentration of total cholesterol, LDL cholesterol, triglycerides, HDL cholesterol)
    • Time Frame: Changes between baseline and the close-out visit (i.e. changes between Month 0 and Month 6)
    • Measured by clinical chemistry
  • Glucose excursion (time-in-range, coefficient of variation)
    • Time Frame: Changes between baseline and the close-out visit (i.e. changes between Month 0 and Month 6)
    • Measured by continuous glucose monitoring

Participating in This Clinical Trial

Inclusion Criteria

  • Age 18-40 years – Breastfeeding mothers at 4-8 week postpartum – With or without gestational diabetes mellitus diagnosed at 24-32 gestational weeks, according to the International Association of Diabetes and Pregnancy Study Groups (IADPSG) consensus criteria – Confident use of a smartphone and able to take regular pictures of food/drinks Exclusion Criteria:

  • Pre-existing diabetes (prior to pregnancy) – Major illness/fever over the 2 weeks (prior to the visits with blood tests) – Shift work or work at irregular hours planned after maternity leave – Active cancer and/or oncologic treatment over the previous 12 months – Coagulation disorder, on regular anticoagulant drug, skin disorder affecting wound healing – Enrolled in a clinical trial / intervention study – Major known mental illness, unable to give informed consent – Inability to follow the study procedures

Gender Eligibility: Female

Minimum Age: 18 Years

Maximum Age: 40 Years

Are Healthy Volunteers Accepted: Accepts Healthy Volunteers

Investigator Details

  • Lead Sponsor
    • University of Lausanne Hospitals
  • Provider of Information About this Clinical Study
    • Principal Investigator: Jardena Puder, Principal investigator – University of Lausanne Hospitals
  • Overall Official(s)
    • Jardena Puder, MD, Principal Investigator, Lausanne University Hospital
    • Tinh-Hai Collet, MD, Principal Investigator, University Hospital, Geneva
  • Overall Contact(s)
    • Sylvie Umwali, +41795566399, sylvie.umwali@chuv.ch

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