Leptin and Cytokines in Diabetic Pregnancy - Physiologic or Pathogenic Role
Recruitment status was Recruiting
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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 |
---|
Gestational Diabetes Mellitus Preeclampsia Placental Hypoxia |
Study Type: | Observational |
Official Title: | Leptin and Cytokines in Diabetic Pregnancy - Physiologic or Pathogenic Role |
Genders Eligible for Study: | Female |
Accepts Healthy Volunteers: | Yes |
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:
-
Contact: Uriel Elchalal, Dr. | 00 972 2 6774356 | elchalal@cc.huji.ac.il |
Contact: Vivian Barak, Prof. | 00 972 2 6776764 | odeliah@ekmd.huji.ac.il |
Israel | |
Hadassah Medical Organization | Recruiting |
Jerusalem, Israel | |
Contact: Arik Tzukert, DMD 00 972 2 6776095 arik@hadassah.org.il | |
Contact: Hadas Lemberg, PhD 00 972 2 6777572 lhadas@hadassah.org.il | |
Principal Investigator: Uriel Elchalal, Dr. |
Principal Investigator: | Uriel Elchalal, Dr. | Hadassah Medical Organization |
Publications:
ClinicalTrials.gov Identifier: | NCT00334841 History of Changes |
Other Study ID Numbers: | 0507874356- HMO-CTIL |
Study First Received: | June 5, 2006 |
Last Updated: | November 5, 2007 |
Health Authority: | Israel: Israeli Health Ministry Pharmaceutical Administration |
Additional relevant MeSH terms:
Diabetes Mellitus Pre-Eclampsia Pregnancy in Diabetics Diabetes, Gestational Anoxia Glucose Metabolism Disorders |
Metabolic Diseases Endocrine System Diseases Hypertension, Pregnancy-Induced Pregnancy Complications Signs and Symptoms, Respiratory Signs and Symptoms |
ClinicalTrials.gov processed this record on October 16, 2012