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Leptin and Cytokines in Diabetic Pregnancy - Physiologic or Pathogenic Role

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified May 2006 by Hadassah Medical Organization.
Recruitment status was:  Recruiting
ClinicalTrials.gov Identifier:
First Posted: June 8, 2006
Last Update Posted: November 6, 2007
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Hadassah Medical Organization

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 Preeclampsia 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

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Senior
Sexes 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
Information from the National Library of Medicine

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 6774356 elchalal@cc.huji.ac.il
Contact: Vivian Barak, Prof. 00 972 2 6776764 odeliah@ekmd.huji.ac.il

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.         
Sponsors and Collaborators
Hadassah Medical Organization
Principal Investigator: Uriel Elchalal, Dr. Hadassah Medical Organization
  More Information

ClinicalTrials.gov Identifier: NCT00334841     History of Changes
Other Study ID Numbers: 0507874356- HMO-CTIL
First Submitted: June 5, 2006
First Posted: June 8, 2006
Last Update Posted: November 6, 2007
Last Verified: May 2006

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes, Gestational
Pregnancy in Diabetics
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Signs and Symptoms, Respiratory
Signs and Symptoms
Pregnancy Complications
Hypertension, Pregnancy-Induced