NCT02916667

Brief 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 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.

Trial Health

35
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
280

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Nov 2016

Typical duration for not_applicable

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 10, 2016

Completed
17 days until next milestone

First Posted

Study publicly available on registry

September 27, 2016

Completed
1 month until next milestone

Study Start

First participant enrolled

November 1, 2016

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 1, 2017

Completed
1.2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

December 1, 2018

Completed
Last Updated

October 11, 2016

Status Verified

October 1, 2016

Enrollment Period

11 months

First QC Date

September 10, 2016

Last Update Submit

October 9, 2016

Conditions

GDM

Outcome Measures

Primary Outcomes (1)

  • 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.

    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.

    2 year

Study Arms (2)

CNdiet

ACTIVE COMPARATOR

CNdiet includes chrono nutritional dietary guidelines

Other: dietary guidelines

GDMdiet

PLACEBO COMPARATOR

GDMdiet includes regular GDM diet

Other: dietary guidelines

Interventions

dietary guidelinesOTHER

dietary guidelines will include chrono- nutrition diet plan

CNdietGDMdiet

Eligibility Criteria

Age18 Years - 40 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • GDM first screened in 24-32 week of prenancy
  • singleton pregnancy
  • GDM screened in "Rabin medical center"
  • signing an informed consent

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Related Publications (12)

  • 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.

    PMID: 24443392BACKGROUND

  • Hiersch 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.

    PMID: 24500517BACKGROUND

  • Schellong 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.

    PMID: 23082214BACKGROUND

  • Yogev 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.

    PMID: 24457570BACKGROUND

  • Asher 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.

    PMID: 25815987BACKGROUND

  • Cagampang 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.

    PMID: 22676899BACKGROUND

  • Tahara 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.

    PMID: 24572815BACKGROUND

  • Reutrakul 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.

    PMID: 24628249BACKGROUND

  • Jakubowicz 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.

    PMID: 23512957BACKGROUND

  • O'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.

    PMID: 22945608BACKGROUND

  • Messika 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.

    PMID: 39796591DERIVED

  • Messika 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.

    PMID: 35525420DERIVED

MeSH Terms

Interventions

Nutrition Policy

Intervention Hierarchy (Ancestors)

Health PolicyPublic PolicySocial Control PoliciesPolicyHealth Care Economics and Organizations

Study Officials

  • Moshe MI Hod, Prof

    head of the division of maternal fetal medicine at the women's hospital at Rabin medical center Israel

    STUDY DIRECTOR

Central Study Contacts

yoel MI toledano, MD

CONTACT

+972-546331268yoelto@clalit.org.il

amalia MI messika, RD

CONTACT

+972-528187913amali.messika@gmail.com

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
PREVENTION
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
principal investigator

Study Record Dates

First Submitted

September 10, 2016

First Posted

September 27, 2016

Study Start

November 1, 2016

Primary Completion

October 1, 2017

Study Completion

December 1, 2018

Last Updated

October 11, 2016

Record last verified: 2016-10

Data Sharing

IPD Sharing
Will not share