Now Available for Public Comment: Notice of Proposed Rulemaking (NPRM) for FDAAA 801 and NIH Draft Reporting Policy for NIH-Funded Trials

Leptin and Cytokines in Diabetic Pregnancy - Physiologic or Pathogenic Role

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2006 by Hadassah Medical Organization.
Recruitment status was  Recruiting
Information provided by:
Hadassah Medical Organization Identifier:
First received: June 5, 2006
Last updated: November 5, 2007
Last verified: May 2006

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.

Gestational Diabetes Mellitus
Placental Hypoxia

Study Type: Observational
Official Title: Leptin and Cytokines in Diabetic Pregnancy - Physiologic or Pathogenic Role

Resource links provided by NLM:

Further study details as provided by Hadassah Medical Organization:

Estimated Enrollment: 30
Study Start Date: July 2006

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:


  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00334841

Contact: Uriel Elchalal, Dr. 00 972 2 6774356
Contact: Vivian Barak, Prof. 00 972 2 6776764

Hadassah Medical Organization Recruiting
Jerusalem, Israel
Contact: Arik Tzukert, DMD    00 972 2 6776095   
Contact: Hadas Lemberg, PhD    00 972 2 6777572   
Principal Investigator: Uriel Elchalal, Dr.         
Sponsors and Collaborators
Hadassah Medical Organization
Principal Investigator: Uriel Elchalal, Dr. Hadassah Medical Organization
  More Information

Publications: 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
Diabetes, Gestational
Pregnancy in Diabetics
Endocrine System Diseases
Glucose Metabolism Disorders
Hypertension, Pregnancy-Induced
Metabolic Diseases
Pregnancy Complications processed this record on November 25, 2014