Circadian Clocks and Eating Patterns (Cohort)

Molecular and Functional Interplay Between the Circadian Clocks and Eating Patterns in Patients with Cardio-metabolic Diseases (Cohort)

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 Overview

• Status: Completed
• Conditions: Diabetes, Gestational; Postpartum Women

• Study Type: Observational
• Enrollment (Actual): 38

Contacts and Locations

Study Locations

• Switzerland
  • Lausanne, Switzerland, 1011
    • Lausanne University Hospital (CHUV)

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 40 years (Adult)
• Accepts Healthy Volunteers: Yes

• Sampling Method: Non-Probability Sample

Study Population

Postpartum women followed at the Lausanne University Hospital (CHUV)

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

2

Cohorts and Interventions

Group / Cohort
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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

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

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
Blood hormonal profile	Insulin and thyroid-stimulating hormone (mIU/L)	Changes between baseline and the close-out visit (i.e. changes between Month 0 and Month 6)
Blood hormonal profile	Cortisol (nmol/L)	Changes between baseline and the close-out visit (i.e. changes between Month 0 and Month 6)
Markers of lipid metabolism	Measured by high-throughput mass spectrometry lipidomics	Changes between baseline and the close-out visit (i.e. changes between Month 0 and Month 6)
Metabolomic parameters of energy metabolism	Measured by high-throughput mass spectrometry metabolomics	Changes between baseline and the close-out visit (i.e. changes between Month 0 and Month 6)

Collaborators and Investigators

• Sponsor: University of Lausanne Hospitals
• Investigators: Principal Investigator: Jardena Puder, MD, Lausanne University Hospital; Principal Investigator: Tinh-Hai Collet, MD, University Hospital, Geneva

Publications and helpful links

General Publications

• 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. 2024 Nov 12. doi: 10.1007/s00125-024-06318-x. Online ahead of print.

Study record dates

Study Major Dates

• Study Start (Actual): February 12, 2020
• Primary Completion (Actual): June 30, 2022
• Study Completion (Actual): June 30, 2022

Study Registration Dates

• First Submitted: November 2, 2020
• First Submitted That Met QC Criteria: November 18, 2020
• First Posted (Actual): November 24, 2020

Study Record Updates

• Last Update Posted (Estimated): December 11, 2024
• Last Update Submitted That Met QC Criteria: December 5, 2024
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Keywords: Metabolic syndrome; Circadian rhythms; Eating duration; Sleep/wake cycles
• Additional Relevant MeSH Terms: Urogenital Diseases; Endocrine System Diseases; Female Urogenital Diseases and Pregnancy Complications; Metabolic Diseases; Pregnancy Complications; Glucose Metabolism Disorders; Diabetes Mellitus; Diabetes, Gestational
• Other Study ID Numbers: 2019-01207

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No