Ignite Creation Date:
2025-12-26 @ 11:46 AM
Ignite Modification Date:
2026-03-02 @ 4:11 AM
Study NCT ID:
NCT01758016
Status:
UNKNOWN
Last Update Posted:
2015-10-07
First Post:
2012-12-23
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Haptoglobin and Diabetes Complications in Pregnancy
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D016640', 'term': 'Diabetes, Gestational'}], 'ancestors': [{'id': 'D011248', 'term': 'Pregnancy Complications'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'bioSpec': {'retention': 'SAMPLES_WITH_DNA', 'description': 'Serum'}, 'studyType': 'OBSERVATIONAL', 'designInfo': {'timePerspective': 'PROSPECTIVE', 'observationalModel': 'COHORT'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 400}, 'patientRegistry': False}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2012-11'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-10', 'completionDateStruct': {'date': '2017-06', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2015-10-06', 'studyFirstSubmitDate': '2012-12-23', 'studyFirstSubmitQcDate': '2012-12-30', 'lastUpdatePostDateStruct': {'date': '2015-10-07', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2012-12-31', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2016-12', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'vascular complications in pregnancy', 'timeFrame': '9 months'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'conditions': ['Diabetes in Pregnancy']}, 'descriptionModule': {'briefSummary': '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.\n\nHaptoglobin (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.\n\nThe 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)'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'samplingMethod': 'PROBABILITY_SAMPLE', 'studyPopulation': '1. Pregastetional diabetic patients currently pregnant\n2. Gestational diabetes patients currently pregnant', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Diabetes in pregnancy\n\nExclusion Criteria:\n\n* Not willing to participate'}, 'identificationModule': {'nctId': 'NCT01758016', 'briefTitle': 'Haptoglobin and Diabetes Complications in Pregnancy', 'organization': {'class': 'OTHER', 'fullName': 'Rambam Health Care Campus'}, 'officialTitle': 'Haptoglobin and Diabetes Complications in Pregnancy', 'orgStudyIdInfo': {'id': '2304-2000-RMB CTIL'}}, 'contactsLocationsModule': {'locations': [{'city': 'Beersheba', 'status': 'RECRUITING', 'country': 'Israel', 'contacts': [{'name': 'Ofer beharier, M.D', 'role': 'CONTACT', 'email': 'oferbeharie@gmail.com', 'phone': '001972525398676'}, {'name': 'Ofer Beharie, M.D', 'role': 'SUB_INVESTIGATOR'}, {'name': 'Eyal Sheiner, M.D', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Soroka Medical Center', 'geoPoint': {'lat': 31.25181, 'lon': 34.7913}}, {'city': 'Haifa', 'status': 'RECRUITING', 'country': 'Israel', 'contacts': [{'name': 'Ron Beloosesky, M.D', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Nizzar KHATIB, M.D', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'Rambam Health Care Cmpus', 'geoPoint': {'lat': 32.81303, 'lon': 34.99928}}, {'city': 'Kfar Saba', 'status': 'RECRUITING', 'country': 'Israel', 'contacts': [{'name': 'Tal Biron-Shental, M.D', 'role': 'CONTACT', 'email': 'Tal.Biron-Shental@clalit.org.il', 'phone': '011972528362331'}, {'name': 'Tal Biron-Shental, M/D', 'role': 'PRINCIPAL_INVESTIGATOR'}], 'facility': 'Meir Hospital', 'geoPoint': {'lat': 32.175, 'lon': 34.90694}}], 'centralContacts': [{'name': 'ron beloosesky, M.D', 'role': 'CONTACT', 'email': 'tomor2304@yahoo.com', 'phone': '011972509205759'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Rambam Health Care Campus', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}