Gut Microbiome and Gestational Diabetes Mellitus
1 other identifier
interventional
400
1 country
1
Brief Summary
The purpose of this study is to document the gut microbiome in the 1st, 2nd and 3rd trimester among pregnant women with gestational diabetes and non diabetic controls.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for not_applicable
Started Feb 2016
Typical duration for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
December 23, 2015
CompletedFirst Posted
Study publicly available on registry
January 7, 2016
CompletedStudy Start
First participant enrolled
February 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 10, 2018
CompletedStudy Completion
Last participant's last visit for all outcomes
December 10, 2018
CompletedSeptember 12, 2019
September 1, 2019
2.9 years
December 23, 2015
September 10, 2019
Conditions
Outcome Measures
Primary Outcomes (1)
Bacterial population diversity
It is a descriptive outcome descibint the physiological composition of the gut and oral microbiome. The microbiome population will be quantified by DNA analysis of the samples collected throughout pregnancy from the oral cavity and stool . The precentage of each baceria colonizing the gut and oral cavitiy will be reported
9 months
Study Arms (3)
Gestational diabetes mellitus
NO INTERVENTIONwomen diagnosed with GDM during pregnancy, either treated by diet or pharmacological therapy
No GDM, Dietary Modifications
ACTIVE COMPARATORWomen without GDM, will be advised and monitored for dietary, Exercise and lifestyle modifications
No GDM, free diet
NO INTERVENTIONWomen without GDM, for whom diet. exercise are continued regulary without any modifications
Interventions
Women without GDM will receive advise on diet, exercise and lifestyle modifications similar to what is advised to women with GDM
Eligibility Criteria
You may qualify if:
- \. Pregnant women at the 1st trimester
You may not qualify if:
- Type 1 Diabetes Mellitus
- Type 2 Diabetes Mellitus
- Post Bariatric surgery
- Any concurrent chronic illness or medication use
- Any use of hormones or antibiotics within prior 3 months
- Multiple gestation
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Rabin Medical Centerlead
- Clalit Health Servicescollaborator
Study Sites (1)
Rabin Medical Center
Petah Tikva, 49100, Israel
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Eran Hadar, MD
Rabin Medical Center
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NON RANDOMIZED
- Masking
- NONE
- Purpose
- BASIC SCIENCE
- Intervention Model
- PARALLEL
- Sponsor Type
- OTHER
- Responsible Party
- PRINCIPAL INVESTIGATOR
- PI Title
- Dr
Study Record Dates
First Submitted
December 23, 2015
First Posted
January 7, 2016
Study Start
February 1, 2016
Primary Completion
December 10, 2018
Study Completion
December 10, 2018
Last Updated
September 12, 2019
Record last verified: 2019-09
Data Sharing
- IPD Sharing
- Will not share