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Clinical Trial Details — Status: Not yet recruiting

Administrative data

NCT number NCT02916667
Other study ID # 0277-15-RMC
Secondary ID
Status Not yet recruiting
Phase N/A
First received September 10, 2016
Last updated October 9, 2016
Start date November 2016
Est. completion date December 2018

Study information

Verified date October 2016
Source Rabin Medical Center
Contact yoel MI toledano, MD
Phone +972-546331268
Email yoelto@clalit.org.il
Is FDA regulated No
Health authority Israel: Ethics Commission
Study type Interventional

Clinical 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 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.


Description:

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Study Design

Allocation: Randomized, Intervention Model: Parallel Assignment, Masking: Single Blind (Subject), Primary Purpose: Prevention


Related Conditions & MeSH terms


Intervention

Other:
dietary guidelines
dietary guidelines will include chrono- nutrition diet plan

Locations

Country Name City State
n/a

Sponsors (1)

Lead Sponsor Collaborator
Rabin Medical Center

References & Publications (10)

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Outcome

Type Measure Description Time frame Safety issue
Primary 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 No
Secondary 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 No
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