- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00334841
Leptin and Cytokines in Diabetic Pregnancy - Physiologic or Pathogenic Role
Leptin, a circulating hormone expressed abundantly in adipose tissue, has been reported to be a satiety factor. In addition, it has been shown to increase during pregnancy in maternal blood, parallel to increase in body fat mass, to correlate with fetal body weight gain and to fall down to basal levels after delivery.
Little is known about leptin levels in pregnant women with preexisting or gestational diabetes and their relationship with fetal and postnatal growth and perinatal complications.
Therefore, the proposed study aims to understand and characterize the role of leptin in gestational diabetes mellitus as well as the relationship between leptin, cytokines and the pathophysiological complications during diabetic pregnancy. Specifically, we will evaluate 60 pregnant women both in Germany and in Israel and evaluate serum levels and mRNA of leptin, cytokines (inflammatory as well as Th1 and Th2) and correlate them to maternal changes of body weight and birth weight in women of various degrees of glucose tolerance and with various degrees of metabolic control during pregnancy; relationship between serum and umbilical cord vein concentrations of leptin, cytokines and metabolic variables; placental expression of leptin, leptin receptor, selected cytokines, GLUT1 and 4 and relationship to leptin in serum and umbilical cord plasma; comparison between all above parameters of German and Israeli pregnant women.
The results of this new and systematic study will shed light on the role of leptin and cytokines in the development of glucose disturbances during pregnancy and the perinatal outcome of women with gestational or preexisting diabetes mellitus.
Study Overview
Status
Study Type
Enrollment (Anticipated)
Contacts and Locations
Study Contact
- Name: Uriel Elchalal, Dr.
- Phone Number: 00 972 2 6774356
- Email: elchalal@cc.huji.ac.il
Study Contact Backup
- Name: Vivian Barak, Prof.
- Phone Number: 00 972 2 6776764
- Email: odeliah@ekmd.huji.ac.il
Study Locations
-
-
-
Jerusalem, Israel
- Recruiting
- Hadassah Medical Organization
-
Principal Investigator:
- Uriel Elchalal, Dr.
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
- Child
- Adult
- Older Adult
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
random glucose challenge test (GCT): 50 g of glucose are orally given at any time of the day. The results are considered as positive if the capillary blood glucose concentrations 1 hour after the load are >130 mg/dl. Those with normal results serve as control group
Exclusion Criteria:
-
Study Plan
How is the study designed?
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Uriel Elchalal, Dr., Hadassah Medical Organization
Publications and helpful links
Study record dates
Study Major Dates
Study Start
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- 0507874356- HMO-CTIL
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Preeclampsia
-
MemorialCare Health SystemNot yet recruitingPreeclampsia | Preeclampsia Postpartum | Preeclampsia Severe | Preeclampsia Mild
-
Christiana Care Health ServicesActive, not recruitingPre-Eclampsia | Preeclampsia | Preterm | Preeclampsia Severe | Preeclampsia Second Trimester | Preeclampsia Complicating Childbirth | Preeclampsia PuerperiumUnited States
-
University Medical Centre LjubljanaCompletedPreeclampsia Postpartum | Preeclampsia SevereSlovenia
-
Cedars-Sinai Medical CenterThermoFisher Scientific Brahms Biomarkers FranceCompletedGestational Hypertension | Preeclampsia Severe | Preeclampsia and Eclampsia | Chronic Hypertension in Obstetric Context | Superimposed Pre-Eclampsia | Preeclampsia MildUnited States
-
Washington University School of MedicineRecruitingPreeclampsia Postpartum | Preeclampsia SevereUnited States
-
Brigham and Women's HospitalCompletedHypertension in Pregnancy | Postpartum | Postpartum Preeclampsia | Gestational Hypertension | Preeclampsia SevereUnited States
-
Christiana Care Health ServicesNot yet recruitingPreterm Birth Complication | Preeclampsia Severe | Preeclampsia Second TrimesterUnited States
-
AMAG Pharmaceuticals, Inc.TerminatedSevere PreeclampsiaUnited States, Poland, South Africa
-
Mpilo Central HospitalCompletedSevere PreeclampsiaZimbabwe