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Trial record 32 of 126 for:    diabetes type 1 AND (woman OR women OR female) AND Metabolism

Biological Changes in the Adipose Tissue Among Pregnant Women With Diabetes

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ClinicalTrials.gov Identifier: NCT02383537
Recruitment Status : Not yet recruiting
First Posted : March 9, 2015
Last Update Posted : September 2, 2016
Sponsor:
Information provided by (Responsible Party):
Hadassah Medical Organization

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.

Condition or disease Intervention/treatment
Pregnancy Diabetes Other: Diabetes

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:

  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

Study Type : Observational
Estimated Enrollment : 150 participants
Observational Model: Case Control
Time Perspective: Prospective
Official Title: Biological Changes in the Adipose Tissue (RNA Profile) Among Pregnant Women With Diabetes
Study Start Date : April 2017
Estimated Primary Completion Date : February 2019
Estimated Study Completion Date : February 2020

Group/Cohort Intervention/treatment
Pregnant women with diabetes
Pregnant women with diabetes type 1, type 2 or gestational diabetes
Other: Diabetes
the trial is observational with no intervention

Healthy pregnant women
Healthy pregnant women with no underlying illness



Primary Outcome Measures :
  1. miRNA profiling [ Time Frame: samles are taken during C-section samples will be analyzed after completion of collection ]


Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   Female
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
Pregnant women with diabetes. Healthy women will serve as a reference group
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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02383537


Contacts
Contact: Uriel Elchalal, Proffessor +972-2-6776424 Uriel@hadassah.org.il

Sponsors and Collaborators
Hadassah Medical Organization
Investigators
Principal Investigator: Uriel Elchalal, Professor Hadassah Ein Keren
Principal Investigator: Ram Weiss, Professor Hebrew University

Responsible Party: Hadassah Medical Organization
ClinicalTrials.gov Identifier: NCT02383537     History of Changes
Other Study ID Numbers: 0633-14-HMO
First Posted: March 9, 2015    Key Record Dates
Last Update Posted: September 2, 2016
Last Verified: March 2015

Additional relevant MeSH terms:
Diabetes Mellitus
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases