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Circadian Clocks and Eating Patterns (Cohort)

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ClinicalTrials.gov Identifier: NCT04642534
Recruitment Status : Recruiting
First Posted : November 24, 2020
Last Update Posted : November 24, 2020
Sponsor:
Information provided by (Responsible Party):
Jardena Puder, University of Lausanne Hospitals

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.


Condition or disease
Postpartum Women Diabetes, Gestational

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Study Type : Observational
Estimated Enrollment : 30 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: Molecular and Functional Interplay Between the Circadian Clocks and Eating Patterns in Patients With Cardio-metabolic Diseases (Cohort)
Actual Study Start Date : February 12, 2020
Estimated Primary Completion Date : February 28, 2022
Estimated Study Completion Date : February 28, 2022

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Postpartum Care

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



Primary Outcome Measures :
  1. 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

  2. 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 Outcome Measures :
  1. 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

  2. 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)

  3. 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

  4. 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

  5. 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

  6. 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

  7. 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

  8. 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

  9. 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


Other Outcome Measures:
  1. Blood hormonal profile [ Time Frame: Changes between baseline and the close-out visit (i.e. changes between Month 0 and Month 6) ]
    Insulin and thyroid-stimulating hormone (mIU/L)

  2. Blood hormonal profile [ Time Frame: Changes between baseline and the close-out visit (i.e. changes between Month 0 and Month 6) ]
    Cortisol (nmol/L)

  3. Markers of lipid metabolism [ Time Frame: Changes between baseline and the close-out visit (i.e. changes between Month 0 and Month 6) ]
    Measured by high-throughput mass spectrometry lipidomics

  4. Metabolomic parameters of energy metabolism [ Time Frame: Changes between baseline and the close-out visit (i.e. changes between Month 0 and Month 6) ]
    Measured by high-throughput mass spectrometry metabolomics


Biospecimen Description:
Blood, serum and plasma Skin biopsy


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 40 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
Postpartum women followed at the Lausanne University Hospital (CHUV)
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04642534


Contacts
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Contact: Sylvie Umwali +41795566399 sylvie.umwali@chuv.ch
Contact: Julie Mareschal, BSc julie.mareschal@chuv.ch

Locations
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Switzerland
Lausanne University Hospital (CHUV) Recruiting
Lausanne, Switzerland, 1011
Contact: Sylvie Umwali    +41795566399    sylvie.umwali@chuv.ch   
Sponsors and Collaborators
University of Lausanne Hospitals
Investigators
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Principal Investigator: Jardena Puder, MD Lausanne University Hospital
Principal Investigator: Tinh-Hai Collet, MD University Hospital, Geneva
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Responsible Party: Jardena Puder, Principal investigator, University of Lausanne Hospitals
ClinicalTrials.gov Identifier: NCT04642534    
Other Study ID Numbers: 2019-01207
First Posted: November 24, 2020    Key Record Dates
Last Update Posted: November 24, 2020
Last Verified: November 2020

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Keywords provided by Jardena Puder, University of Lausanne Hospitals:
Circadian rhythms
Metabolic syndrome
Eating duration
Sleep/wake cycles
Additional relevant MeSH terms:
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Diabetes, Gestational
Pregnancy Complications
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases