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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03170245
Recruitment Status : Recruiting
First Posted : May 31, 2017
Last Update Posted : September 18, 2019
Sponsor:
Information provided by (Responsible Party):
Asmaa Nady Hussein, Assiut University

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 .

Condition or disease Intervention/treatment
Thalassemia Diagnostic Test: Interleukin-6 Diagnostic Test: HsC-RP Diagnostic Test: Adiponectin level Diagnostic Test: Carotid intima media thickness

Show Show detailed description

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Study Type : Observational
Estimated Enrollment : 80 participants
Observational Model: Case-Control
Time Perspective: Prospective
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
Actual Study Start Date : August 1, 2018
Estimated Primary Completion Date : January 1, 2020
Estimated Study Completion Date : September 2020

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Thalassemia

Group/Cohort Intervention/treatment
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
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

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
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




Primary Outcome Measures :
  1. Adiponectin [ Time Frame: once (1 day) ]
    Estimated by ElISA


Secondary Outcome Measures :
  1. HsC-reactive protein [ Time Frame: once (1 day) ]
    By ELISA

  2. Interleukin-6 [ Time Frame: once (1 day) ]
    By ELISA

  3. carotid intima media thickness [ Time Frame: once (1 day) ]
    By carotid doppler


Biospecimen Retention:   Samples Without DNA
Whole blood and serum to be used


Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


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Ages Eligible for Study:   16 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Probability Sample
Study Population
All B thalassemia parients who admitted to Clinical Hematology Unit - Internal Medicine Department at Assiut University Gospital
Criteria

Inclusion Criteria:

  • B thalassemia patients

Exclusion Criteria:

  • Diabetes mellitus
  • Hypertension
  • Obesity

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03170245


Contacts
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Contact: Osama A Ibraheim, MD 00201006372498 oibrahiem@yahoo.com
Contact: Walaa H Mohammed, MD 00201005220944 walaa.hosny2012@gmail.com

Locations
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Egypt
Assiut University Hospital Recruiting
Assiut, Egypt, Assiut university 71515
Sponsors and Collaborators
Assiut University

Publications:

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Responsible Party: Asmaa Nady Hussein, Principal investigator, Assiut University
ClinicalTrials.gov Identifier: NCT03170245    
Other Study ID Numbers: ADICIBT
First Posted: May 31, 2017    Key Record Dates
Last Update Posted: September 18, 2019
Last Verified: September 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Thalassemia
beta-Thalassemia
Anemia, Hemolytic, Congenital
Anemia, Hemolytic
Anemia
Hematologic Diseases
Hemoglobinopathies
Genetic Diseases, Inborn