Biological Changes in the Adipose Tissue Among Pregnant Women With Diabetes

Diabetes Clinical Trial

Official title:

Biological Changes in the Adipose Tissue (RNA Profile) Among Pregnant Women With Diabetes

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT02383537
• Other study ID #: 0633-14-HMO
• Status: Not yet recruiting
• Phase: N/A
• First received: March 4, 2015
• Last updated: September 1, 2016
• Start date: April 2017
• Est. completion date: February 2020

Study information

• Verified date: March 2015
• Source: Hadassah Medical Organization
• Contact: Uriel Elchalal, Proffessor
• Phone: +972-2-6776424
• Email: Uriel[@]hadassah.org.il
• Is FDA regulated: No
• Health authority: Israel: Ethics Commission
• Study type: Observational

Clinical Trial 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.

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:

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

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 150
• Est. completion date: February 2020
• Est. primary completion date: February 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Female
• Age group: 18 Years to 45 Years

Eligibility

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

Study Design

Observational Model: Case Control, Time Perspective: Prospective

Related Conditions & MeSH terms

• Diabetes
• Diabetes Mellitus
• Pregnancy

Intervention

Other:
• Diabetes
the trial is observational with no intervention

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Hadassah Medical Organization

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	miRNA profiling		samles are taken during C-section samples will be analyzed after completion of collection	No