Biological Changes in the Adipose Tissue Among Pregnant W... | NCT02383537

Studies
Biological Changes in the Adipose Tissue Among Pregnant Women With Diabetes

NCT02383537

Sponsor

Hadassah Medical Organization

Status

Unknown status

Last Update Posted

Sep 2, 2016Estimated

Enrollment

150Estimated

Phase

Not provided

Conditions

Pregnancy
Diabetes

Interventions

Diabetes

Countries

Not provided

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Mar 2015

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Apr 2017

Primary Completion Date

Feb 2019Estimated

Completion Date

Feb 2020Estimated

First Submitted Date

Mar 4, 2015

First Submission Date that Met QC Criteria

Mar 4, 2015

First Posted Date

Mar 9, 2015Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 1, 2016

Last Update Posted Date

Sep 2, 2016Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

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.
Bloods will be analyzed for insulin, c-peptide, glucose and fat profile
Placenta and fat tissue will be analyzed for miRNA and total RNA
Clinical and anthropometric measurements will be taken from the mother
Placenta status will be taken

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

150Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
Diabetes	Other	the trial is observational with no intervention	Pregnant women with diabetes

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
miRNA profiling		samles are taken during C-section samples will be analyzed after completion of collection

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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

Accepts Healthy Volunteers

Yes

Sex

Female

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

45 Years

Standard Ages

Adult

Study Population

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

Sampling Method

Probability Sample

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Uriel Elchalal, Proffessor	Contact	+972-2-6776424		Uriel@hadassah.org.il

Overall Officials

Name	Affiliation	Role
Uriel Elchalal, Professor	Hadassah Ein Keren	Principal Investigator
Ram Weiss, Professor	Hebrew University	Principal Investigator

Locations

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D003920	Diabetes Mellitus

Ancestor Terms

ID	Term
D044882	Glucose Metabolism Disorders
D008659	Metabolic Diseases
D009750	Nutritional and Metabolic Diseases
D004700	Endocrine System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided