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Haptoglobin and Diabetes Complications in Pregnancy

This study is currently recruiting participants.
Verified October 2015 by Rambam Health Care Campus
Sponsor:
ClinicalTrials.gov Identifier:
NCT01758016
First Posted: December 31, 2012
Last Update Posted: October 7, 2015
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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
Rambam Health Care Campus
  Purpose

Pregnancies of patients with Diabetes are associated with increase adverse pregnancy outcome . The risk for vascular complications including: Intra uterine growth restriction (20%), hypertension (31%), preeclampsia (15%), eclampsia and placental abruption are significantly greater than those in background populations. The risk of developing vascular complications in diabetes pregnancies although is correlated with the severity and length of the disease is not fully understood. Enhanced oxidation has been suggested to be the underlying abnormality responsible for some of the complications of diabetes.

Haptoglobin (Hp) is an abundant plasma glycoprotein produced in the liver. The best understood function of Hp is to bind free hemoglobin (Hb) released from red blood cells. Extracorpuscular Hb is a potent Fenton reagent.capable of of inflicting oxidative tissue damage. Hp binds to Hb and serves to inhibit the oxidative potential of Hb by preventing the release of heme iron.

The haptoglobin (Hp) gene at chromosomal locus 16q22 is polymorphic, with two common alleles denoted 1 and 2. the prevalence of Hp 1-1, Hp 1-2 and Hp 2-2 genotypes is approximately 16%, 48% and 36%, respectively. In the western world. A total of five independent longitudinal studies have demonstrated that DM individuals with Hp 2-2 genotype have a two to five-fold increased risk of CVD as compared to DM individuals without the Hp 2-2 genotype We sought to determine whether HP genotype plays important role in development of vascular complications in pregastational pregnancies. and whether Hp genotype 2-2 is a risk factor for developing gestational diabetes (GDM)


Condition
Diabetes in Pregnancy

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Prospective
Official Title: Haptoglobin and Diabetes Complications in Pregnancy

Resource links provided by NLM:


Further study details as provided by Rambam Health Care Campus:

Primary Outcome Measures:
  • vascular complications in pregnancy [ Time Frame: 9 months ]

Biospecimen Retention:   Samples With DNA
Serum

Estimated Enrollment: 400
Study Start Date: November 2012
Estimated Study Completion Date: June 2017
Estimated Primary Completion Date: December 2016 (Final data collection date for primary outcome measure)
  Eligibility

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:   No
Sampling Method:   Probability Sample
Study Population
  1. Pregastetional diabetic patients currently pregnant
  2. Gestational diabetes patients currently pregnant
Criteria

Inclusion Criteria:

  • Diabetes in pregnancy

Exclusion Criteria:

  • Not willing to participate
  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): NCT01758016


Contacts
Contact: ron beloosesky, M.D 011972509205759 tomor2304@yahoo.com

Locations
Israel
Soroka Medical Center Recruiting
Be'er Sheva`, Israel
Contact: Ofer beharier, M.D    001972525398676    oferbeharie@gmail.com   
Sub-Investigator: Ofer Beharie, M.D         
Principal Investigator: Eyal Sheiner, M.D         
Rambam Health Care Cmpus Recruiting
Haifa, Israel
Principal Investigator: Ron Beloosesky, M.D         
Sub-Investigator: Nizzar KHATIB, M.D         
Meir Hospital Recruiting
Kfar Saba, Israel
Contact: Tal Biron-Shental, M.D    011972528362331    Tal.Biron-Shental@clalit.org.il   
Principal Investigator: Tal Biron-Shental, M/D         
Sponsors and Collaborators
Rambam Health Care Campus
  More Information

Responsible Party: Rambam Health Care Campus
ClinicalTrials.gov Identifier: NCT01758016     History of Changes
Other Study ID Numbers: 2304-2000-RMB CTIL
First Submitted: December 23, 2012
First Posted: December 31, 2012
Last Update Posted: October 7, 2015
Last Verified: October 2015

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Complications
Pregnancy in Diabetics
Diabetes, Gestational
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Pregnancy Complications


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