Biological Changes in the Adipose Tissue Among Pregnant Women With Diabetes

NCT ID: NCT02383537

Last Updated: 2016-09-02

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

150 participants

Study Classification

OBSERVATIONAL

Study Start Date

2017-04-30

Study Completion Date

2020-02-29

Brief Summary

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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.

Detailed Description

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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:

1. fat tissue, Umbilical cord blood, placenta tissue and subcutaneous fat will be taken from pregnant diabetic woman over going a C-section.
2. Bloods will be analyzed for insulin, c-peptide, glucose and fat profile
3. Placenta and fat tissue will be analyzed for miRNA and total RNA
4. Clinical and anthropometric measurements will be taken from the mother
5. Placenta status will be taken

Conditions

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Pregnancy Diabetes

Study Design

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Observational Model Type

CASE_CONTROL

Study Time Perspective

PROSPECTIVE

Study Groups

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Pregnant women with diabetes

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

Diabetes

Intervention Type OTHER

the trial is observational with no intervention

Healthy pregnant women

Healthy pregnant women with no underlying illness

No interventions assigned to this group

Interventions

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Diabetes

the trial is observational with no intervention

Intervention Type OTHER

Eligibility Criteria

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Inclusion Criteria

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

Exclusion Criteria

* \<18 or \>45
* chronic illness that may effect the outcome
* polypharmacy
Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Hadassah Medical Organization

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Uriel Elchalal, Professor

Role: PRINCIPAL_INVESTIGATOR

Hadassah Ein Keren

Ram Weiss, Professor

Role: PRINCIPAL_INVESTIGATOR

Hebrew University

Central Contacts

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Uriel Elchalal, Proffessor

Role: CONTACT

+972-2-6776424

Other Identifiers

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0633-14-HMO

Identifier Type: -

Identifier Source: org_study_id

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