Leptin and Cytokines in Diabetic Pregnancy - Physiologic or Pathogenic Role

NCT ID: NCT00334841

Last Updated: 2007-11-06

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Total Enrollment

30 participants

Study Classification

OBSERVATIONAL

Study Start Date

2006-07-31

Brief Summary

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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.

Detailed Description

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Conditions

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Gestational Diabetes Mellitus Preeclampsia Placental Hypoxia

Eligibility Criteria

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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

\-
Eligible Sex

FEMALE

Accepts Healthy Volunteers

Yes

Sponsors

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Hadassah Medical Organization

OTHER

Sponsor Role lead

Principal Investigators

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Uriel Elchalal, Dr.

Role: PRINCIPAL_INVESTIGATOR

Hadassah Medical Organization

Locations

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Hadassah Medical Organization

Jerusalem, , Israel

Site Status RECRUITING

Countries

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Israel

Central Contacts

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Uriel Elchalal, Dr.

Role: CONTACT

Phone: 00 972 2 6774356

Email: [email protected]

Vivian Barak, Prof.

Role: CONTACT

Phone: 00 972 2 6776764

Email: [email protected]

Facility Contacts

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Arik Tzukert, DMD

Role: primary

Hadas Lemberg, PhD

Role: backup

References

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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.

Reference Type BACKGROUND
PMID: 16135665 (View on PubMed)

Other Identifiers

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0507874356- HMO-CTIL

Identifier Type: -

Identifier Source: org_study_id