Haptoglobin and Diabetes Complications in Pregnancy
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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 |
- 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 |
- Pregastetional diabetic patients currently pregnant
- Gestational diabetes patients currently pregnant
Inclusion Criteria:
- Diabetes in pregnancy
Exclusion Criteria:
- Not willing to participate
Contacts and Locations| Contact: ron beloosesky, M.D | 011972509205759 | tomor2304@yahoo.com |
| 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 | |
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 May 21, 2013