Circadian Clocks and Eating Patterns (Cohort)

NCT04642534 | Completed

• 1 other identifier: 2019-01207
• Study Type: observational
• Target: 38
• Locations: 1 country
• Sites: 1

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

Outcome Measures

Primary Outcomes (2)

• Eating duration

  Duration from the first to last caloric intake over 24-hour cycle

  Changes between baseline and the close-out visit (i.e. changes between Month 0 and Month 6)

• Correlation of in vitro circadian parameters (amplitude and magnitude) with clinical metabolic health outcomes (body weight)

  Measured in cultured skin fibroblasts

  At baseline

Secondary Outcomes (9)

• Sleep/wake cycles

  Changes between baseline and the close-out visit (i.e. changes between Month 0 and Month 6)

• Sleep/wake cycles

  Changes between baseline and the close-out visit (i.e. changes between Month 0 and Month 6)

• Body weight

  Changes between baseline and the close-out visit (i.e. changes between Month 0 and Month 6)

• Fat mass

  Changes between baseline and the close-out visit (i.e.changes between Month 0 and Month 6)

• Fat-free mass

  Changes between baseline and the close-out visit (i.e. changes between Month 0 and Month 6)

Other Outcomes (4)

• Blood hormonal profile

  Changes between baseline and the close-out visit (i.e. changes between Month 0 and Month 6)

• Blood hormonal profile

  Changes between baseline and the close-out visit (i.e. changes between Month 0 and Month 6)

• Markers of lipid metabolism

  Changes between baseline and the close-out visit (i.e. changes between Month 0 and Month 6)

Study Arms (2)

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

Eligibility Criteria

• Age: 18 Years - 40 Years
• Sex: female
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)
• Sampling Method: Non-Probability Sample

Study Population

Postpartum women followed at the Lausanne University Hospital (CHUV)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• University of Lausanne Hospitals: lead

Study Sites (1)

Lausanne University Hospital (CHUV)

Lausanne, 1011, Switzerland

Location

Related Publications (1)

• 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.

  PMID: 39531039 BACKGROUND

Biospecimen

Blood, serum and plasma Skin biopsy

MeSH Terms

Conditions

Diabetes, Gestational; Metabolic Syndrome

Condition Hierarchy (Ancestors)

Pregnancy Complications; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases; Insulin Resistance; Hyperinsulinism

Study Officials

• Jardena Puder, MD

  University of Lausanne Hospitals

  PRINCIPAL INVESTIGATOR

• Tinh-Hai Collet, MD

  University Hospital, Geneva

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: November 2, 2020
• First Posted: November 24, 2020
• Study Start: February 12, 2020
• Primary Completion: June 30, 2022
• Study Completion: June 30, 2022
• Last Updated: December 11, 2024

Record last verified: 2022-10

Data Sharing

• IPD Sharing: Will not share

Locations

CH (1)