Leptin and Cytokines in Diabetic Pregnancy - Physiologic or Pathogenic Role
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|ClinicalTrials.gov Identifier: NCT00334841|
Recruitment Status : Unknown
Verified May 2006 by Hadassah Medical Organization.
Recruitment status was: Recruiting
First Posted : June 8, 2006
Last Update Posted : November 6, 2007
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.
|Condition or disease|
|Gestational Diabetes Mellitus Preeclampsia Placental Hypoxia|
|Study Type :||Observational|
|Estimated Enrollment :||30 participants|
|Official Title:||Leptin and Cytokines in Diabetic Pregnancy - Physiologic or Pathogenic Role|
|Study Start Date :||July 2006|
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): NCT00334841
|Contact: Uriel Elchalal, Dr.||00 972 2 firstname.lastname@example.org|
|Contact: Vivian Barak, Prof.||00 972 2 email@example.com|
|Principal Investigator:||Uriel Elchalal, Dr.||Hadassah Medical Organization|