Haptoglobin and Diabetes Complications in Pregnancy

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2012 by Rambam Health Care Campus
Sponsor:
Information provided by (Responsible Party):
Rambam Health Care Campus
ClinicalTrials.gov Identifier:
NCT01758016
First received: December 23, 2012
Last updated: December 30, 2012
Last verified: December 2012
  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 ] [ Designated as safety issue: No ]

Biospecimen Retention:   Samples With DNA

Serum


Estimated Enrollment: 400
Study Start Date: November 2012
Estimated Study Completion Date: June 2014
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
  Eligibility

Genders 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
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 ClinicalTrials.gov identifier: 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

No publications provided

Responsible Party: Rambam Health Care Campus
ClinicalTrials.gov Identifier: NCT01758016     History of Changes
Other Study ID Numbers: 2304-2000-RMB CTIL
Study First Received: December 23, 2012
Last Updated: December 30, 2012
Health Authority: Israel: Ministry of Health

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

ClinicalTrials.gov processed this record on August 20, 2014