Postpartum WomenNCT04642534
Circadian Clocks and Eating Patterns (Cohort)
An observational study of Postpartum Women and Diabetes, Gestational, run by University of Lausanne Hospitals at 1 site in Switzerland.
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… Read more about this study
- Who is it for?
- Ages 18 to 40 years, women onlyHealthy volunteers can take part
- Conditions the study is for
- Postpartum Women, Diabetes, Gestational
- How many people
- 38 participants
- Where
- 1 siteSwitzerland
- Study dates
- 12 Feb 2020to 30 Jun 2022
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 40 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Postpartum women followed at the Lausanne University Hospital (CHUV)
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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.
Read more
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
- Medical subject headings
- Diabetes, Gestational, Metabolic Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| 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 being measured
The primary outcome is the main question the study is designed to answer.
Eating duration
Duration from the first to last caloric intake over 24-hour cycle
Measured: 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
Measured: At baseline
Secondary outcomes (9)
Sleep/wake cycles
Measured by actigraphy
Measured: 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)
Measured: Changes between baseline and the close-out visit (i.e. changes between Month 0 and Month 6)
Body weight
Measured by bioelectrical impedance analysis
Measured: Changes between baseline and the close-out visit (i.e. changes between Month 0 and Month 6)
Fat mass
Measured by bioelectrical impedance analysis
Measured: 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
Measured: 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
Measured: Changes between baseline and the close-out visit (i.e. changes between Month 0 and Month 6)
Fasting glucose
Measured by clinical chemistry
Measured: 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
Measured: 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
Measured: Changes between baseline and the close-out visit (i.e. changes between Month 0 and Month 6)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted24 Nov 2020
- Study start12 Feb 2020
- Primary completion30 Jun 2022
- Study completion30 Jun 2022
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Postpartum WomenStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 38 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Lausanne Hospitals
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Jardena Puder, University of Lausanne Hospitals
- Investigators
- Jardena Puder, MD, Principal investigator, University of Lausanne HospitalsTinh-Hai Collet, MD, Principal investigator, University Hospital, Geneva
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04642534
- Sponsor's protocol ID
- 2019-01207
- Other IDs
- 2019
- Status last verified
- Oct 2022
- First submitted
- 2 Nov 2020
- Last updated
- 11 Dec 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
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. 2025 Feb;68(2):419-432. doi: 10.1007/s00125-024-06318-x. Epub 2024 Nov 12.
PubMed 39531039
Study at a glance
From the registry record, last updated by the sponsor on 11 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Molecular and Functional Interplay Between the Circadian Clocks and Eating Patterns in Patients With Cardio-metabolic Diseases (Cohort)
- ClinicalTrials.gov ID
- NCT04642534
- Acronym / sponsor ID
- 2019-01207
- Conditions
- Postpartum Women, Diabetes, Gestational
- Keywords
- Circadian rhythms, Metabolic syndrome, Eating duration, Sleep/wake cycles
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 38 participants (actual)
- Lead sponsor
- University of Lausanne HospitalsUniversity, hospital or other
- Study start
- 12 Feb 2020 (actual)
- Primary completion
- 30 Jun 2022 (actual)
- Study completion
- 30 Jun 2022 (actual)
- First posted
- 24 Nov 2020 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 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 |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Postpartum women followed at the Lausanne University Hospital (CHUV)
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (8 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
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
9 secondary outcomes
Sleep/wake cycles
Time frame: Changes between baseline and the close-out visit (i.e. changes between Month 0 and Month 6)
Sleep/wake cycles
Time frame: Changes between baseline and the close-out visit (i.e. changes between Month 0 and Month 6)
Body weight
Time frame: Changes between baseline and the close-out visit (i.e. changes between Month 0 and Month 6)
Fat mass
Time frame: Changes between baseline and the close-out visit (i.e.changes between Month 0 and Month 6)
Fat-free mass
Time frame: Changes between baseline and the close-out visit (i.e. changes between Month 0 and Month 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)
Fasting glucose
Time frame: 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)
Time frame: 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)
Time frame: Changes between baseline and the close-out visit (i.e. changes between Month 0 and Month 6)
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Dec 2024.
- Results publication: PubMed 39531039Phillips 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Jardena Puder, MD principal investigator
University of Lausanne Hospitals
Tinh-Hai Collet, MD principal investigator
University Hospital, Geneva
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Postpartum Women and Diabetes, Gestational, run by University of Lausanne Hospitals at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 11 Dec 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Eating duration (time frame: Changes between baseline and the close-out visit (i.e. changes between Month 0 and Month 6)). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT04642534, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Dec 2024.