NCT02383537

Brief Summary

The aim of the research is to study the effect of miRNA, fat tissue and insulin resistance on the pathophysiology of diabetes during pregnancy. During the study fat tissue, Umbilical cord blood, placenta tissue and subcutaneous fat will be taken from pregnant diabetic woman over going a C-section. Healthy pregnant women will serve as a 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
150

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Apr 2017

Typical duration for all trials

Status
unknown

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

March 4, 2015

Completed
5 days until next milestone

First Posted

Study publicly available on registry

March 9, 2015

Completed
2.1 years until next milestone

Study Start

First participant enrolled

April 1, 2017

Completed
1.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

February 1, 2019

Completed
1 year until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2020

Completed
Last Updated

September 2, 2016

Status Verified

March 1, 2015

Enrollment Period

1.8 years

First QC Date

March 4, 2015

Last Update Submit

September 1, 2016

Conditions

PregnancyDiabetes

Outcome Measures

Primary Outcomes (1)

  • miRNA profiling

    samles are taken during C-section samples will be analyzed after completion of collection

Study Arms (2)

Pregnant women with diabetes

Pregnant women with diabetes type 1, type 2 or gestational diabetes

Other: Diabetes

Healthy pregnant women

Healthy pregnant women with no underlying illness

Interventions

DiabetesOTHER

the trial is observational with no intervention

Pregnant women with diabetes

Eligibility Criteria

Age18 Years - 45 Years
Sexfemale
Healthy VolunteersYes
Age GroupsAdult (18-64)
Sampling MethodProbability Sample
Study Population

Pregnant women with diabetes. Healthy women will serve as a reference group

You may qualify if:

  • age 18-45
  • pregnant
  • signed consent form
  • going through an elective C-section
  • Diabetic
  • reference group: healthy women with no background illness

You may not qualify if:

  • \<18 or \>45
  • chronic illness that may effect the outcome
  • polypharmacy

Contact the study team to confirm eligibility.

Sponsors & Collaborators

MeSH Terms

Conditions

Diabetes Mellitus

Condition Hierarchy (Ancestors)

Glucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Officials

  • Uriel Elchalal, Professor

    Hadassah Ein Keren

    PRINCIPAL INVESTIGATOR

  • Ram Weiss, Professor

    Hebrew University

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Uriel Elchalal, Proffessor

CONTACT

+972-2-6776424Uriel@hadassah.org.il

Study Design

Study Type
observational
Observational Model
CASE CONTROL
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

March 4, 2015

First Posted

March 9, 2015

Study Start

April 1, 2017

Primary Completion

February 1, 2019

Study Completion

February 1, 2020

Last Updated

September 2, 2016

Record last verified: 2015-03