Haptoglobin and Diabetes Complications in Pregnancy

Diabetes in Pregnancy Clinical Trial

Official title:

Haptoglobin and Diabetes Complications in Pregnancy

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01758016
• Other study ID #: 2304-2000-RMB CTIL
• Status: Recruiting
• Phase: N/A
• First received: December 23, 2012
• Last updated: October 6, 2015
• Start date: November 2012
• Est. completion date: June 2017

Study information

• Verified date: October 2015
• Source: Rambam Health Care Campus
• Contact: ron beloosesky, M.D
• Phone: 011972509205759
• Email: tomor2304[@]yahoo.com
• Is FDA regulated: No
• Health authority: Israel: Ministry of Health
• Study type: Observational

Clinical Trial Summary

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)

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 400
• Est. completion date: June 2017
• Est. primary completion date: December 2016
• Accepts healthy volunteers: No
• Gender: Female
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Diabetes in pregnancy

Exclusion Criteria:

• Not willing to participate

Study Design

Observational Model: Cohort, Time Perspective: Prospective

Related Conditions & MeSH terms

• Diabetes Complications
• Diabetes in Pregnancy
• Diabetes, Gestational
• Pregnancy in Diabetics

Locations

Country	Name	City	State
Israel	Soroka Medical Center	Be'er Sheva`
Israel	Rambam Health Care Cmpus	Haifa
Israel	Meir Hospital	Kfar Saba

Sponsors (1)

Lead Sponsor	Collaborator
Rambam Health Care Campus

Country where clinical trial is conducted

Israel, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	vascular complications in pregnancy		9 months	No