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Leptin and Cytokines in Diabetic Pregnancy - Physiologic or Pathogenic Role

Primary Purpose

Gestational Diabetes Mellitus, Preeclampsia, Placental Hypoxia

Status
Unknown status
Phase
Locations
Israel
Study Type
Observational
Intervention
Sponsored by
Hadassah Medical Organization
About
Eligibility
Locations
Outcomes
Full info

About this trial

This is an observational trial for Gestational Diabetes Mellitus

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)FemaleAccepts Healthy Volunteers

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: -

Sites / Locations

  • Hadassah Medical OrganizationRecruiting

Outcomes

Primary Outcome Measures

Secondary Outcome Measures

Full Information

First Posted
June 5, 2006
Last Updated
November 5, 2007
Sponsor
Hadassah Medical Organization
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1. Study Identification

Unique Protocol Identification Number
NCT00334841
Brief Title
Leptin and Cytokines in Diabetic Pregnancy - Physiologic or Pathogenic Role
Official Title
Leptin and Cytokines in Diabetic Pregnancy - Physiologic or Pathogenic Role
Study Type
Observational

2. Study Status

Record Verification Date
May 2006
Overall Recruitment Status
Unknown status
Study Start Date
July 2006 (undefined)
Primary Completion Date
undefined (undefined)
Study Completion Date
undefined (undefined)

3. Sponsor/Collaborators

Name of the Sponsor
Hadassah Medical Organization

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Gestational Diabetes Mellitus, Preeclampsia, Placental Hypoxia

7. Study Design

Enrollment
30 (Anticipated)

10. Eligibility

Sex
Female
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
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: -
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Uriel Elchalal, Dr.
Phone
00 972 2 6774356
Email
elchalal@cc.huji.ac.il
First Name & Middle Initial & Last Name or Official Title & Degree
Vivian Barak, Prof.
Phone
00 972 2 6776764
Email
odeliah@ekmd.huji.ac.il
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Uriel Elchalal, Dr.
Organizational Affiliation
Hadassah Medical Organization
Official's Role
Principal Investigator
Facility Information:
Facility Name
Hadassah Medical Organization
City
Jerusalem
Country
Israel
Individual Site Status
Recruiting
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Arik Tzukert, DMD
Phone
00 972 2 6776095
Email
arik@hadassah.org.il
First Name & Middle Initial & Last Name & Degree
Hadas Lemberg, PhD
Phone
00 972 2 6777572
Email
lhadas@hadassah.org.il
First Name & Middle Initial & Last Name & Degree
Uriel Elchalal, Dr.

12. IPD Sharing Statement

Citations:
PubMed Identifier
16135665
Citation
Lappas M, Yee K, Permezel M, Rice GE. Release and regulation of leptin, resistin and adiponectin from human placenta, fetal membranes, and maternal adipose tissue and skeletal muscle from normal and gestational diabetes mellitus-complicated pregnancies. J Endocrinol. 2005 Sep;186(3):457-65. doi: 10.1677/joe.1.06227.
Results Reference
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Leptin and Cytokines in Diabetic Pregnancy - Physiologic or Pathogenic Role

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