Viewing Study NCT00334841



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Study NCT ID: NCT00334841
Status: UNKNOWN
Last Update Posted: 2007-11-06
First Post: 2006-06-05

Brief Title: Leptin and Cytokines in Diabetic Pregnancy - Physiologic or Pathogenic Role
Sponsor: Hadassah Medical Organization
Organization: Hadassah Medical Organization

Study Overview

Official Title: Leptin and Cytokines in Diabetic Pregnancy - Physiologic or Pathogenic Role
Status: UNKNOWN
Status Verified Date: 2006-05
Last Known Status: RECRUITING
Delayed Posting: No
If Stopped, Why?: Not Stopped
Has Expanded Access: False
If Expanded Access, NCT#: N/A
Has Expanded Access, NCT# Status: N/A
Acronym: None
Brief Summary: 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
Detailed Description: None

Study Oversight

Has Oversight DMC: None
Is a FDA Regulated Drug?: None
Is a FDA Regulated Device?: None
Is an Unapproved Device?: None
Is a PPSD?: None
Is a US Export?: None
Is an FDA AA801 Violation?: None