Circadian Clocks and Eating Patterns (Cohort)

NCT ID: NCT04642534

Last Updated: 2024-12-11

Basic Information

• Recruitment Status: COMPLETED
• Total Enrollment: 38 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2020-02-12
• Study Completion Date: 2022-06-30

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.

Conditions

Postpartum Women; Diabetes, Gestational

Keywords

Circadian rhythms; Metabolic syndrome; Eating duration; Sleep/wake cycles

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Study Groups

Postpartum women who had gestational diabetes mellitus

Inclusion at 4-8 weeks postpartum Follow-up for 6 months

No interventions assigned to this group

Postpartum women after an uneventful pregnancy

Inclusion at 4-8 weeks postpartum Follow-up for 6 months

No interventions assigned to this group

Eligibility Criteria

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

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: FEMALE
• Accepts Healthy Volunteers: Yes

Sponsors

University of Lausanne Hospitals

OTHER

Sponsor Role: lead

Responsible Party

Jardena Puder

Principal investigator

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Jardena Puder, MD

Role: PRINCIPAL_INVESTIGATOR

University of Lausanne Hospitals

Tinh-Hai Collet, MD

Role: PRINCIPAL_INVESTIGATOR

University Hospital, Geneva

Locations

Lausanne University Hospital (CHUV)

Lausanne, , Switzerland

Countries

Switzerland

References

Phillips NE, Mareschal J, Biancolin AD, Sinturel F, Umwali S, Blanc S, Hemmer A, Naef F, Salathe M, Dibner C, Puder JJ, Collet TH. The metabolic and circadian signatures of gestational diabetes in the postpartum period characterised using multiple wearable devices. Diabetologia. 2025 Feb;68(2):419-432. doi: 10.1007/s00125-024-06318-x. Epub 2024 Nov 12.

Reference Type: BACKGROUND

PMID: 39531039 (View on PubMed)

Other Identifiers

2019-01207

Identifier Type: -

Identifier Source: org_study_id