Haptoglobin and Diabetes Complications in Pregnancy
1 other identifier
observational
400
1 country
3
Brief 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)
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P75+ for all trials
Started Nov 2012
Longer than P75 for all trials
3 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
Click on a node to explore related trials.
Study Timeline
Key milestones and dates
Study Start
First participant enrolled
November 1, 2012
CompletedFirst Submitted
Initial submission to the registry
December 23, 2012
CompletedFirst Posted
Study publicly available on registry
December 31, 2012
CompletedPrimary Completion
Last participant's last visit for primary outcome
December 1, 2016
CompletedStudy Completion
Last participant's last visit for all outcomes
June 1, 2017
CompletedOctober 7, 2015
October 1, 2015
4.1 years
December 23, 2012
October 6, 2015
Conditions
Outcome Measures
Primary Outcomes (1)
vascular complications in pregnancy
9 months
Eligibility Criteria
1. Pregastetional diabetic patients currently pregnant 2. Gestational diabetes patients currently pregnant
You may qualify if:
- Diabetes in pregnancy
You may not qualify if:
- Not willing to participate
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (3)
Soroka Medical Center
Beersheba, Israel
Rambam Health Care Cmpus
Haifa, Israel
Meir Hospital
Kfar Saba, Israel
Biospecimen
Serum
MeSH Terms
Conditions
Condition Hierarchy (Ancestors)
Central Study Contacts
Study Design
- Study Type
- observational
- Observational Model
- COHORT
- Time Perspective
- PROSPECTIVE
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
December 23, 2012
First Posted
December 31, 2012
Study Start
November 1, 2012
Primary Completion
December 1, 2016
Study Completion
June 1, 2017
Last Updated
October 7, 2015
Record last verified: 2015-10