Circadian Clocks and Eating Patterns (Cohort)

Diabetes, Gestational Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT04642534
• Other study ID #: 2019-01207
• Status: Completed
• Start date: February 12, 2020
• Est. completion date: June 30, 2022

Study information

• Verified date: October 2022
• Source: University of Lausanne Hospitals
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 38
• Est. completion date: June 30, 2022
• Est. primary completion date: June 30, 2022
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 40 Years

Eligibility

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

Related Conditions & MeSH terms

• Diabetes, Gestational
• Postpartum Women

Locations

Country	Name	City	State
Switzerland	Lausanne University Hospital (CHUV)	Lausanne

Sponsors (1)

Lead Sponsor	Collaborator
University of Lausanne Hospitals

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Other	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)
Other	Blood hormonal profile	Cortisol (nmol/L)	Changes between baseline and the close-out visit (i.e. changes between Month 0 and Month 6)
Other	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)
Other	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)
Primary	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)
Primary	Correlation of in vitro circadian parameters (amplitude and magnitude) with clinical metabolic health outcomes (body weight)	Measured in cultured skin fibroblasts	At baseline
Secondary	Sleep/wake cycles	Measured by actigraphy	Changes between baseline and the close-out visit (i.e. changes between Month 0 and Month 6)
Secondary	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)
Secondary	Body weight	Measured by bioelectrical impedance analysis	Changes between baseline and the close-out visit (i.e. changes between Month 0 and Month 6)
Secondary	Fat mass	Measured by bioelectrical impedance analysis	Changes between baseline and the close-out visit (i.e.changes between Month 0 and Month 6)
Secondary	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)
Secondary	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)
Secondary	Fasting glucose	Measured by clinical chemistry	Changes between baseline and the close-out visit (i.e. changes between Month 0 and Month 6)
Secondary	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)
Secondary	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)