GDMCNNCT02916667
Chrono Nutrition (CN) Intervention Program in Gestational Diabetes Mellitus
A study testing dietary guidelines in people with GDM, run by Rabin Medical Center.
Trial summary
Working hypothesis and aims: To asses Chrono Biological factors during the third trimester of gestational diabetes melittus (GDM) with birth weight and related complications. The investigators hypothesize that participants with GDM pregnancies with higher Chrono Biologocal status will be ended with higher birth weight… 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
- GDM
- What is being tested?
- dietary guidelines
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 280 participants
- Where
- No sites listed yet
- Study dates
- Nov 2016to Dec 2018
- Phase
- Interventional
- 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
Who may be able to join
- GDM first screened in 24-32 week of prenancy
- singleton pregnancy
- GDM screened in "Rabin medical center"
- signing an informed consent
Who cannot join
- women with history of metabolic disorder such as dislipidemia, heart disease, cancer, type 1 diabetes, type 2 diabetes, hypertension, kidney disease,liver disease, thyroids disorder, cancer.
- women with history of fertility drug therapy such as IVF or progsterone
- women who work night shifts
- women who work in air crew
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Chrono Nutrition Intervention Program in Gestational Diabetes Mellitus
Working hypothesis and aims:
To asses Chrono Biological factors during the third trimester of gestational diabetes melittus (GDM) with birth weight and related complications. The investigators hypothesize that participants with GDM pregnancies with higher Chrono Biologocal status will be ended with higher birth weight compared to participants with GDM pregnancies with lower status. In addition, the investigators hypothesize that the Chrono Nutritional intervention program will contribute to the reduction of the rate of birth weight above percentile 90 compared with the participants with GDM in the control group.
Read the detailed description
Background: Many studies have linked pre-pregnancy obesity and the metabolic syndrome, with an increased risk of developing gestational diabetes mellitus (GDM). These factors are associate with increased risk of newborn obesity, insulin resistance and diabetes. Recently, studies have shown that the "Chrono-Biological" (CB) aspects need to be considered in this context. These factors are related to endogenous circadian clocks, which regulate many body functions depending upon cycle of light and darkness during a day of almost 24 hours. By tracks daily fluctuations in heart rate, blood pressure, hormone secretion and control of a variety of metabolic pathways. Factors that can affect the setting of the circadian clock may include; Change dark and light hours, consumptions of certain nutrients during the day and more.
Chronic rhythm disruption associated with the development of obesity, diabetes, and more. Factors such as "chrono-nutrition" (CN) have a significant impact on variations in circadian rhythms includes: meals program schedule, glucose, saturated fat, caffeine and alcohol intake, and the ratio of macronutrients. Intervention studies in adults who are obese and diabetes were able to reduce the impact of these disorders by changing the composition and schedule of meals that lead to weight loss and diabetes control. Moreover, Insomnia during pregnancy can be caused by disorders CB. Insomnia affects 30-40% of all pregnancies. Some sleep disorders can be worsening by pregnancy, particularly overweight. Currently, routine monitoring and treatment of women with GDM does not include screening for sleep disorders and CN factors.
Working hypothesis and aims: To asses CB factors during the third trimester of participants with GDM pregnancies with a weight of childbirth and related complications. The investigators hypothesize that participants with GDM pregnancies with higher CB status will be ended with higher birth weight compared to participants with GDM pregnancies with a lower status.
In addition, the investigators assume that the CN intervention program will contribute to reducing the rate of birth weight above the 90 percentile compared to control group.
Methods: In a prospective cohort study, n= 280, The investigators will review the obstetric outcomes and the impact of CB disorders and complications for mother and fetus, through questionnaires. In a clinical trial n=100, The investigators will assess the effect of CN intervention on birth weight in participants with GDM pregnancies.
Expected results: Based on the investigators preliminary research and literature, The investigators expected that due to the increasing prevalence of obesity and sleep disturbance among GDM pregnancies , and the feasibility of high interference CN factors in pregnancy, Therefore, it is important to examine the impact of CB factors on maternal and fetal.
The importance of the study: Since there is a high probability that GDM is exposed to the interference of CB factors which are not monitored during GDM, this unique study, is of great importance for understanding the potential impact of the CB factors on higher birth weight rates.
- Conditions
- GDM
- Being tested
- dietary guidelines
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
dietary guidelinesOther
dietary guidelines will include chrono- nutrition diet plan
| Study group | Role | What they receive |
|---|---|---|
| CNdiet | Active comparator | CNdiet includes chrono nutritional dietary guidelines Receives: Other: dietary guidelines |
| GDMdiet | Placebo comparator | GDMdiet includes regular GDM diet Receives: Other: dietary guidelines |
What is being measured
The primary outcome is the main question the study is designed to answer.
Offspring of participants with GDM with higher Chrono Biological score will be reported with higher birth weight (+100 gr) compared to offspring of participants with GDM with lower Chrono Biological score.
Measured: 2 year
Secondary outcomes (1)
Offspring of participants with GDM with higher Chrono Biological score will be reported with higher birth weight above the 90 percentile compared to offspring of participants with GDM with lower Chrono Biological score.
Measured: 2 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted27 Sep 2016 (estimated)
- Study startNov 2016
- Primary completionOct 2017 (estimated)
- Study completionDec 2018 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (12)Papers the sponsor has linked to this study.
- Other trials for GDMStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 280 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Rabin Medical Center
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yoel Toledano, Rabin Medical Center
- Investigators
- Moshe MI Hod, Prof, Study director, head of the division of maternal fetal medicine at the women's hospital at Rabin medical center Israel
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02916667
- Sponsor's protocol ID
- 0277-15-RMC
- Acronym
- CN
- Status last verified
- Oct 2016
- First submitted
- 10 Sep 2016
- Last updated
- 11 Oct 2016
- Results posted
- No
- Data monitoring committee
- No
- Individual data sharing
- No
Publications
Donnelly JM, Walsh JM, Byrne J, Molloy EJ, McAuliffe FM. Impact of maternal diet on neonatal anthropometry: a randomized controlled trial. Pediatr Obes. 2015 Feb;10(1):52-6. doi: 10.1111/j.2047-6310.2013.00216.x. Epub 2014 Jan 20.
PubMed 24443392Hiersch L, Yogev Y. Impact of gestational hyperglycemia on maternal and child health. Curr Opin Clin Nutr Metab Care. 2014 May;17(3):255-60. doi: 10.1097/MCO.0000000000000030.
PubMed 24500517Schellong K, Schulz S, Harder T, Plagemann A. Birth weight and long-term overweight risk: systematic review and a meta-analysis including 643,902 persons from 66 studies and 26 countries globally. PLoS One. 2012;7(10):e47776. doi: 10.1371/journal.pone.0047776. Epub 2012 Oct 17.
PubMed 23082214Yogev Y, Hiersch L. Pregnancy: impact of maternal nutrition on intrauterine fetal growth. World Rev Nutr Diet. 2014;109:101-8. doi: 10.1159/000356110. Epub 2014 Jan 16. No abstract available.
PubMed 24457570Asher G, Sassone-Corsi P. Time for food: the intimate interplay between nutrition, metabolism, and the circadian clock. Cell. 2015 Mar 26;161(1):84-92. doi: 10.1016/j.cell.2015.03.015.
PubMed 25815987Cagampang FR, Bruce KD. The role of the circadian clock system in nutrition and metabolism. Br J Nutr. 2012 Aug;108(3):381-92. doi: 10.1017/S0007114512002139. Epub 2012 Jun 8.
PubMed 22676899Tahara Y, Shibata S. Chrono-biology, chrono-pharmacology, and chrono-nutrition. J Pharmacol Sci. 2014;124(3):320-35. doi: 10.1254/jphs.13r06cr. Epub 2014 Feb 27.
PubMed 24572815Reutrakul S, Van Cauter E. Interactions between sleep, circadian function, and glucose metabolism: implications for risk and severity of diabetes. Ann N Y Acad Sci. 2014 Apr;1311:151-73. doi: 10.1111/nyas.12355. Epub 2014 Mar 14.
PubMed 24628249Jakubowicz D, Barnea M, Wainstein J, Froy O. High caloric intake at breakfast vs. dinner differentially influences weight loss of overweight and obese women. Obesity (Silver Spring). 2013 Dec;21(12):2504-12. doi: 10.1002/oby.20460. Epub 2013 Jul 2.
PubMed 23512957O'Keeffe M, St-Onge MP. Sleep duration and disorders in pregnancy: implications for glucose metabolism and pregnancy outcomes. Int J Obes (Lond). 2013 Jun;37(6):765-70. doi: 10.1038/ijo.2012.142. Epub 2012 Sep 4.
PubMed 22945608Messika A, Toledano Y, Hadar E, Tauman R, Froy O, Shamir R. Chronobiological Factors Influencing Glycemic Control and Birth Outcomes in Gestational Diabetes Mellitus. Nutrients. 2024 Dec 31;17(1):157. doi: 10.3390/nu17010157.
PubMed 39796591Messika A, Toledano Y, Hadar E, Shmuel E, Tauman R, Shamir R, Froy O. Relationship among chrononutrition, sleep, and glycemic control in women with gestational diabetes mellitus: a randomized controlled trial. Am J Obstet Gynecol MFM. 2022 Sep;4(5):100660. doi: 10.1016/j.ajogmf.2022.100660. Epub 2022 May 4.
PubMed 35525420
Study at a glance
From the registry record, last updated by the sponsor on 11 Oct 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Chrono Nutrition Intervention Program in Gestational Diabetes Mellitus
- ClinicalTrials.gov ID
- NCT02916667
- Acronym / sponsor ID
- CN / 0277-15-RMC
- Conditions
- GDM
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 280 participants (estimated)
- Lead sponsor
- Rabin Medical CenterUniversity, hospital or other
- Study start
- Nov 2016
- Primary completion
- Oct 2017 (estimated)
- Study completion
- Dec 2018 (estimated)
- First posted
- 27 Sep 2016 (estimated)
- 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.
Working hypothesis and aims:
To asses Chrono Biological factors during the third trimester of gestational diabetes melittus (GDM) with birth weight and related complications. The investigators hypothesize that participants with GDM pregnancies with higher Chrono Biologocal status will be ended with higher birth weight compared to participants with GDM pregnancies with lower status. In addition, the investigators hypothesize that the Chrono Nutritional intervention program will contribute to the reduction of the rate of birth weight above percentile 90 compared with the participants with GDM in the control group.
Detailed description
Background: Many studies have linked pre-pregnancy obesity and the metabolic syndrome, with an increased risk of developing gestational diabetes mellitus (GDM). These factors are associate with increased risk of newborn obesity, insulin resistance and diabetes. Recently, studies have shown that the "Chrono-Biological" (CB) aspects need to be considered in this context. These factors are related to endogenous circadian clocks, which regulate many body functions depending upon cycle of light and darkness during a day of almost 24 hours. By tracks daily fluctuations in heart rate, blood pressure, hormone secretion and control of a variety of metabolic pathways. Factors that can affect the setting of the circadian clock may include; Change dark and light hours, consumptions of certain nutrients during the day and more.
Chronic rhythm disruption associated with the development of obesity, diabetes, and more. Factors such as "chrono-nutrition" (CN) have a significant impact on variations in circadian rhythms includes: meals program schedule, glucose, saturated fat, caffeine and alcohol intake, and the ratio of macronutrients. Intervention studies in adults who are obese and diabetes were able to reduce the impact of these disorders by changing the composition and schedule of meals that lead to weight loss and diabetes control. Moreover, Insomnia during pregnancy can be caused by disorders CB. Insomnia affects 30-40% of all pregnancies. Some sleep disorders can be worsening by pregnancy, particularly overweight. Currently, routine monitoring and treatment of women with GDM does not include screening for sleep disorders and CN factors.
Working hypothesis and aims: To asses CB factors during the third trimester of participants with GDM pregnancies with a weight of childbirth and related complications. The investigators hypothesize that participants with GDM pregnancies with higher CB status will be ended with higher birth weight compared to participants with GDM pregnancies with a lower status.
In addition, the investigators assume that the CN intervention program will contribute to reducing the rate of birth weight above the 90 percentile compared to control group.
Methods: In a prospective cohort study, n= 280, The investigators will review the obstetric outcomes and the impact of CB disorders and complications for mother and fetus, through questionnaires. In a clinical trial n=100, The investigators will assess the effect of CN intervention on birth weight in participants with GDM pregnancies.
Expected results: Based on the investigators preliminary research and literature, The investigators expected that due to the increasing prevalence of obesity and sleep disturbance among GDM pregnancies , and the feasibility of high interference CN factors in pregnancy, Therefore, it is important to examine the impact of CB factors on maternal and fetal.
The importance of the study: Since there is a high probability that GDM is exposed to the interference of CB factors which are not monitored during GDM, this unique study, is of great importance for understanding the potential impact of the CB factors on higher birth weight rates.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CNdiet | Active comparator | Other: dietary guidelinesCNdiet includes chrono nutritional dietary guidelines |
| GDMdiet | Placebo comparator | Other: dietary guidelinesGDMdiet includes regular GDM diet |
Who may qualify
- Ages
- 18 to 40 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- GDM first screened in 24-32 week of prenancy
- singleton pregnancy
- GDM screened in "Rabin medical center"
- signing an informed consent
Key exclusion criteria (4 listed)
- women with history of metabolic disorder such as dislipidemia, heart disease, cancer, type 1 diabetes, type 2 diabetes, hypertension, kidney disease,liver disease, thyroids disorder, cancer.
- women with history of fertility drug therapy such as IVF or progsterone
- women who work night shifts
- women who work in air crew
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| dietary guidelinesdietary guidelines will include chrono- nutrition diet plan | Other | CNdiet, GDMdiet |
Primary outcome
Offspring of participants with GDM with higher Chrono Biological score will be reported with higher birth weight (+100 gr) compared to offspring of participants with GDM with lower Chrono Biological score.
Time frame: 2 year
1 secondary outcome
Offspring of participants with GDM with higher Chrono Biological score will be reported with higher birth weight above the 90 percentile compared to offspring of participants with GDM with lower Chrono Biological score.
Time frame: 2 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 11 Oct 2016.
- Background: PubMed 24443392Donnelly JM, Walsh JM, Byrne J, Molloy EJ, McAuliffe FM. Impact of maternal diet on neonatal anthropometry: a randomized controlled trial. Pediatr Obes. 2015 Feb;10(1):52-6. doi: 10.1111/j.2047-6310.2013.00216.x. Epub 2014 Jan 20.
- Background: PubMed 24500517Hiersch L, Yogev Y. Impact of gestational hyperglycemia on maternal and child health. Curr Opin Clin Nutr Metab Care. 2014 May;17(3):255-60. doi: 10.1097/MCO.0000000000000030.
- Background: PubMed 23082214Schellong K, Schulz S, Harder T, Plagemann A. Birth weight and long-term overweight risk: systematic review and a meta-analysis including 643,902 persons from 66 studies and 26 countries globally. PLoS One. 2012;7(10):e47776. doi: 10.1371/journal.pone.0047776. Epub 2012 Oct 17.
- Background: PubMed 24457570Yogev Y, Hiersch L. Pregnancy: impact of maternal nutrition on intrauterine fetal growth. World Rev Nutr Diet. 2014;109:101-8. doi: 10.1159/000356110. Epub 2014 Jan 16. No abstract available.
- Background: PubMed 25815987Asher G, Sassone-Corsi P. Time for food: the intimate interplay between nutrition, metabolism, and the circadian clock. Cell. 2015 Mar 26;161(1):84-92. doi: 10.1016/j.cell.2015.03.015.
- Background: PubMed 22676899Cagampang FR, Bruce KD. The role of the circadian clock system in nutrition and metabolism. Br J Nutr. 2012 Aug;108(3):381-92. doi: 10.1017/S0007114512002139. Epub 2012 Jun 8.
- Background: PubMed 24572815Tahara Y, Shibata S. Chrono-biology, chrono-pharmacology, and chrono-nutrition. J Pharmacol Sci. 2014;124(3):320-35. doi: 10.1254/jphs.13r06cr. Epub 2014 Feb 27.
- Background: PubMed 24628249Reutrakul S, Van Cauter E. Interactions between sleep, circadian function, and glucose metabolism: implications for risk and severity of diabetes. Ann N Y Acad Sci. 2014 Apr;1311:151-73. doi: 10.1111/nyas.12355. Epub 2014 Mar 14.
- Background: PubMed 23512957Jakubowicz D, Barnea M, Wainstein J, Froy O. High caloric intake at breakfast vs. dinner differentially influences weight loss of overweight and obese women. Obesity (Silver Spring). 2013 Dec;21(12):2504-12. doi: 10.1002/oby.20460. Epub 2013 Jul 2.
- Background: PubMed 22945608O'Keeffe M, St-Onge MP. Sleep duration and disorders in pregnancy: implications for glucose metabolism and pregnancy outcomes. Int J Obes (Lond). 2013 Jun;37(6):765-70. doi: 10.1038/ijo.2012.142. Epub 2012 Sep 4.
- Derived from this study: PubMed 39796591Messika A, Toledano Y, Hadar E, Tauman R, Froy O, Shamir R. Chronobiological Factors Influencing Glycemic Control and Birth Outcomes in Gestational Diabetes Mellitus. Nutrients. 2024 Dec 31;17(1):157. doi: 10.3390/nu17010157.
- Derived from this study: PubMed 35525420Messika A, Toledano Y, Hadar E, Shmuel E, Tauman R, Shamir R, Froy O. Relationship among chrononutrition, sleep, and glycemic control in women with gestational diabetes mellitus: a randomized controlled trial. Am J Obstet Gynecol MFM. 2022 Sep;4(5):100660. doi: 10.1016/j.ajogmf.2022.100660. Epub 2022 May 4.
- Individual participant dataSharing planned: No
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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.
Moshe MI Hod, Prof study director
head of the division of maternal fetal medicine at the women's hospital at Rabin medical center Israel
Questions about this trial
What is this clinical trial studying?
A study testing dietary guidelines in people with GDM, run by Rabin Medical Center.
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 4 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: status not confirmed, as of the sponsor's last update on 11 Oct 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact yoel MI toledano, MD (+972-546331268 ext. ISRAEL, yoelto@clalit.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Offspring of participants with GDM with higher Chrono Biological score will be reported with higher birth weight (+100 gr) compared to offspring of participants with GDM with lower Chrono Biological score. (time frame: 2 year). 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 NCT02916667, which also lists 12 linked publications.
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 Oct 2016.