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Adiponectin, IL-6 and hsC-RP in Relation to Carotid Intima-media Thickness in B-thalassemia Patients

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ClinicalTrials.gov Identifier: NCT03170245
Recruitment Status : Completed
First Posted : May 31, 2017
Last Update Posted : February 16, 2021
Sponsor:
Information provided by (Responsible Party):
Asmaa Nady Hussein, Assiut University

Tracking Information
First Submitted Date May 26, 2017
First Posted Date May 31, 2017
Last Update Posted Date February 16, 2021
Actual Study Start Date August 1, 2018
Actual Primary Completion Date January 30, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: May 30, 2017)
Adiponectin [ Time Frame: once (1 day) ]
Estimated by ElISA
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: May 30, 2017)
  • HsC-reactive protein [ Time Frame: once (1 day) ]
    By ELISA
  • Interleukin-6 [ Time Frame: once (1 day) ]
    By ELISA
  • carotid intima media thickness [ Time Frame: once (1 day) ]
    By carotid doppler
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Adiponectin, IL-6 and hsC-RP in Relation to Carotid Intima-media Thickness in B-thalassemia Patients
Official Title Adiponectin, Interleukin-6 (IL-6) and High Sensitive C-reactive Protein (hsC-RP) in Relation to Carotid Intima-media Thickness in B-thalassemia Patients
Brief Summary Every year, 100,000 neonates are born with hemoglobinopathies around the world. Thalassemia is the most common heterogeneous disease of the human being . It is a disease of high prevalence in Mediterranean, Indian, North Chinese, and Pacific populations. Recently, the quantity and quality of the life of these patients have been significantly improved by regular transfusion and iron chelating therapy .
Detailed Description

β-thalassemia result from a decrease in β- globin chains which result in a relative excess of α-globin chains . Approximately 1.5% of the population is estimated to be carriers for β-thalassemia . Around 60,000 new births are recorded to be affected by β-thalassemia per year in the world . In Egypt, it was estimated that 1000/1.5 million live births per year suffer from thalassemia; β -thalassemia is the most common type, with a carrier rate starting from 5.3%-9% . Depending on severity of hematological and clinical conditions, β-thalassemia is classified into three types, namely, β-thalassemia minor (β-TMI) (also called as carrier), β-thalassemia intermedia (β-TI) and β-thalassemia major (β-TM). The clinical severity of β-thalassemia intermedia has ranged from asymptomatic carrier state to severe transfusion-dependent type. β-Thalassemia minor is clinically asymptomatic but can be characterized by specific hematological features .

A high incidence of thromboembolic event has been observed in patients with β -thalassemia. Endothelial dysfunction occurred in those patients was attributed to peroxidative tissue injury because of continuous blood transfusions . Carotid atherosclerosis was positively associated with serum ferritin independent of traditional cardiovascular risk factors and transfusion-related iron overload in β-thalassemia major (β-TM) has been associated with the onset of cardiovascular complications, including cardiac dysfunction and vascular anomalies. Increased iron overload has also been reported in patients with non-transfusion dependent thalassemia (NTDT) Direct iron-related injury is responsible for different kinds of cardiovascular abnormalities, including progressive worsening of diastolic and systolic ventricular function, increased arterial stiffness and pulmonary hypertension .

It has previously demonstrated that both patients with β-TM and β-TI exhibit a global impairment of arterial vasorelaxation and increased carotid intima-media thickness (cIMT) as compared with control healthy subjects , those findings strongly support the notion that the severe arterial dysfunction in thalassemia may indicate an additional clinical vulnerability for venous thromboembolism. Epidemiologically, vascular events appear at a relatively young age with a four times higher incidence in β-TI as compared with β-TM patients . Carotid intima-media thickness is related both with incident and prevalent cardiovascular disease and is accepted measure of subclinical atherosclerosis . It also increases the risk for future myocardial infarction (MI) .

Lipid abnormalities have been detected in different types of β -thalassemia, and also in various hematological disorders including sickle cell disease, glucose-6-phosphate dehydrogenase (G6PD) deficiency, spherocytosis, aplastic anemia and myelodysplastic syndrome . Patients with β - thalassemia are at risk of developing premature atherosclerosis because of those abnormalities .

Inflammatory biomarkers including C-reactive proteins and cytokines (IL-6) are found to be increased in various inflammatory conditions and have been used by a number of workers as biomarker of inflammation in thalassemia . The iron laden insult to the tissues in transfusion dependent thalassemic patients has been monitored using the high sensitive C-reactive proteins as biomarker of inflammation and vascular risk .

High Sensitive C-reactive protein(hsC-RP)is clinically proven as a method to predict vascular risk and to enhance event rates in clinical trials. As hsC-RP and IL-6 levels measured in apparently healthy populations also predict future vascular risk; hsC-RP and IL-6 levels have been shown to correlate with endothelial dysfunction, arterial stiffness, and extent of subclinical atherosclerosis . IL-6 signaling has also been linked to plaque initiation and destabilization , to microvascular flow dysfunction , and to adverse outcomes in the setting of acute ischemia .

Adiponectin, an adipose tissue secreted protein, has been well recognized to exhibit insulin-sensitizing, anti-inflammatory and anti-atherosclerotic properties . Its level is associated with atherosclerosis markers such as inflammation, oxidative stress, and endothelial dysfunction . Its anti-inflammatory action, resulting in decreased production and inhibition of tumor necrosis factor-α (TNF-α) action, decreased IL-6 production, and human studies previously reported an inverse association between adiponectin level and C-RP , TNF-α and IL-6 .

Adiponectin varies according to body mass index with lower levels in obese individuals , in type 2 diabetes mellitus (T2DM) and in hypertensive patients.

Circulating low adiponectin levels (hypoadiponectinemia) is considered an independent risk factor for endothelial dysfunction and modulating vessel wall health . It has been correlated with elevated risk factors of atherosclerotic cardiovascular disease and associated with hypertension, dyslipidemia, and inflammation in both the general population and in diabetic patients .

Study Type Observational
Study Design Observational Model: Case-Control
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples Without DNA
Description:
Whole blood and serum to be used
Sampling Method Probability Sample
Study Population All B thalassemia parients who admitted to Clinical Hematology Unit - Internal Medicine Department at Assiut University Gospital
Condition Thalassemia
Intervention
  • Diagnostic Test: Interleukin-6
    serum samples used for doing the test by ELISA
  • Diagnostic Test: HsC-RP
    serum samples used for doing the test by ELISA
  • Diagnostic Test: Adiponectin level
    serum samples used for doing the test by ELISA
  • Diagnostic Test: Carotid intima media thickness
    Done by carotid doppler
Study Groups/Cohorts
  • B thalassemia group

    Laboratory investigations :

    • complete blood count
    • renal and liver function tests
    • serum ferritin
    • lipid profile
    • Interleukin -6
    • HsC-RP
    • Adiponectin level

    Imaging :

    • Abdominal ultrasound
    • Echocardiography
    • Carotid intima media thickness
    Interventions:
    • Diagnostic Test: Interleukin-6
    • Diagnostic Test: HsC-RP
    • Diagnostic Test: Adiponectin level
    • Diagnostic Test: Carotid intima media thickness
  • Control group

    Laboratory investigations :

    • complete blood count
    • renal and liver function tests
    • serum ferritin
    • lipid profile
    • Interleukin -6
    • HsC-RP
    • Adiponectin level

    Imaging :

    • Abdominal ultrasound
    • Echocardiography
    • Carotid intima media thickness
    Interventions:
    • Diagnostic Test: Interleukin-6
    • Diagnostic Test: HsC-RP
    • Diagnostic Test: Adiponectin level
    • Diagnostic Test: Carotid intima media thickness
Publications *

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: February 15, 2021)
85
Original Estimated Enrollment
 (submitted: May 30, 2017)
80
Actual Study Completion Date February 15, 2021
Actual Primary Completion Date January 30, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • B thalassemia patients

Exclusion Criteria:

  • Diabetes mellitus
  • Hypertension
  • Obesity
Sex/Gender
Sexes Eligible for Study: All
Ages 16 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers Yes
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Egypt
Removed Location Countries  
 
Administrative Information
NCT Number NCT03170245
Other Study ID Numbers ADICIBT
Has Data Monitoring Committee No
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement
Plan to Share IPD: No
Current Responsible Party Asmaa Nady Hussein, Assiut University
Original Responsible Party Asmaa Nady Hussein, Assiut University, Director
Current Study Sponsor Assiut University
Original Study Sponsor Asmaa Nady Hussein
Collaborators Not Provided
Investigators Not Provided
PRS Account Assiut University
Verification Date February 2021