PregnancyNCT02383537
Biological Changes in the Adipose Tissue Among Pregnant Women With Diabetes
An observational study of Pregnancy and Diabetes, run by Hadassah Medical Organization.
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. Read more about this study
- Who is it for?
- Ages 18 to 45 years, women onlyHealthy volunteers can take part
- What is being tested?
- Diabetes
- How many people
- 150 participants
- Where
- No sites listed yet
- Study dates
- Apr 2017to Feb 2020
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- Women only
- Healthy volunteers accepted
- Adult
Study population: Pregnant women with diabetes. Healthy women will serve as a reference group
Who may be able to join
- age 18-45
- pregnant
- signed consent form
- going through an elective C-section
- Diabetic
- reference group: healthy women with no background illness
Who cannot join
- <18 or >45
- chronic illness that may effect the outcome
- polypharmacy
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Biological Changes in the Adipose Tissue (RNA Profile) Among Pregnant Women With Diabetes
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.
Read the 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
- Being tested
- Diabetes
- Medical subject headings
- Diabetes Mellitus
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DiabetesOther
the trial is observational with no intervention
| Study group | Role | What they receive |
|---|---|---|
| Pregnant women with diabetes | Pregnant women with diabetes type 1, type 2 or gestational diabetes Receives: Other: Diabetes | |
| Healthy pregnant women | Healthy pregnant women with no underlying illness |
What is being measured
The primary outcome is the main question the study is designed to answer.
miRNA profiling
Measured: samles are taken during C-section samples will be analyzed after completion of collection
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Mar 2015 (estimated)
- Study startApr 2017
- Primary completionFeb 2019 (estimated)
- Study completionFeb 2020 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for PregnancyStudies of the same condition, open and under way.
- More trials run by Hadassah Medical OrganizationThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Prospective
- Enrolment
- 150 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Hadassah Medical Organization
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Uriel Elchalal, Professor, Principal investigator, Hadassah Ein KerenRam Weiss, Professor, Principal investigator, Hebrew University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02383537
- Sponsor's protocol ID
- 0633-14-HMO
- Status last verified
- Mar 2015
- First submitted
- 4 Mar 2015
- Last updated
- 2 Sep 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Sep 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Biological Changes in the Adipose Tissue (RNA Profile) Among Pregnant Women With Diabetes
- ClinicalTrials.gov ID
- NCT02383537
- Acronym / sponsor ID
- 0633-14-HMO
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 150 participants (estimated)
- Lead sponsor
- Hadassah Medical OrganizationUniversity, hospital or other
- Study start
- Apr 2017
- Primary completion
- Feb 2019 (estimated)
- Study completion
- Feb 2020 (estimated)
- First posted
- 9 Mar 2015 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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
Study design
- Observational model
- Case-control
- Time perspective
- Prospective
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Pregnant women with diabetes | – | Other: DiabetesPregnant women with diabetes type 1, type 2 or gestational diabetes |
| Healthy pregnant women | – | –Healthy pregnant women with no underlying illness |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- Female only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Pregnant women with diabetes. Healthy women will serve as a reference group
Key inclusion criteria (6 listed)
- age 18-45
- pregnant
- signed consent form
- going through an elective C-section
- Diabetic
Key exclusion criteria (3 listed)
- <18 or >45
- chronic illness that may effect the outcome
- polypharmacy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Diabetesthe trial is observational with no intervention | Other | Pregnant women with diabetes |
Primary outcome
miRNA profiling
Time frame: samles are taken during C-section samples will be analyzed after completion of collection
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Sep 2016.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Uriel Elchalal, Professor principal investigator
Hadassah Ein Keren
Ram Weiss, Professor principal investigator
Hebrew University
Questions about this trial
What is this clinical trial studying?
An observational study of Pregnancy and Diabetes, run by Hadassah Medical Organization.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 2 Sep 2016. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Uriel Elchalal, Proffessor (+972-2-6776424, Uriel@hadassah.org.il), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
miRNA profiling (time frame: samles are taken during C-section samples will be analyzed after completion of collection). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 2 Sep 2016.