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

NCT03170245 | Completed

• 1 other identifier: ADICIBT
• Study Type: observational
• Target: 85
• Locations: 1 country
• Sites: 1

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 .

Conditions

Thalassemia

Outcome Measures

Primary Outcomes (1)

• Adiponectin

  Estimated by ElISA

  once (1 day)

Secondary Outcomes (3)

• HsC-reactive protein

  once (1 day)

• Interleukin-6

  once (1 day)

• carotid intima media thickness

  once (1 day)

Study Arms (2)

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; 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

Diagnostic Test: Interleukin-6; Diagnostic Test: HsC-RP; Diagnostic Test: Adiponectin level; Diagnostic Test: Carotid intima media thickness

Interventions

Interleukin-6 DIAGNOSTIC_TEST

serum samples used for doing the test by ELISA

B thalassemia group; Control group

HsC-RP DIAGNOSTIC_TEST

serum samples used for doing the test by ELISA

B thalassemia group; Control group

Adiponectin level DIAGNOSTIC_TEST

serum samples used for doing the test by ELISA

B thalassemia group; Control group

Carotid intima media thickness DIAGNOSTIC_TEST

Done by carotid doppler

B thalassemia group; Control group

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)
• Sampling Method: Probability Sample

Study Population

All B thalassemia parients who admitted to Clinical Hematology Unit - Internal Medicine Department at Assiut University Gospital

You may qualify if:

• B thalassemia patients

You may not qualify if:

• Diabetes mellitus
• Hypertension
• Obesity

Sponsors & Collaborators

• Assiut University: lead

Study Sites (1)

Assiut University Hospital

Asyut, Assiut university 71515, Egypt

Location

Related Publications (13)

• Hahalis G, Kremastinos DT, Terzis G, Kalogeropoulos AP, Chrysanthopoulou A, Karakantza M, Kourakli A, Adamopoulos S, Tselepis AD, Grapsas N, Siablis D, Zoumbos NC, Alexopoulos D. Global vasomotor dysfunction and accelerated vascular aging in beta-thalassemia major. Atherosclerosis. 2008 Jun;198(2):448-57. doi: 10.1016/j.atherosclerosis.2007.09.030. Epub 2007 Nov 7.

  PMID: 17988670 BACKGROUND

• Stoyanova E, Trudel M, Felfly H, Lemsaddek W, Garcia D, Cloutier G. Vascular endothelial dysfunction in beta-thalassemia occurs despite increased eNOS expression and preserved vascular smooth muscle cell reactivity to NO. PLoS One. 2012;7(6):e38089. doi: 10.1371/journal.pone.0038089. Epub 2012 Jun 19.

  PMID: 22723848 BACKGROUND

• Hahalis G, Kalogeropoulos A, Terzis G, Tselepis AD, Kourakli A, Mylona P, Grapsas N, Alexopoulos D. Premature atherosclerosis in non-transfusion-dependent beta-thalassemia intermedia. Cardiology. 2011;118(3):159-63. doi: 10.1159/000327997. Epub 2011 Jun 1.

  PMID: 21646780 BACKGROUND

• Chen YG, Lin CL, Ho CL, Chen YC, Kao CH. Risk of coronary artery disease in transfusion-naive thalassemia populations: A nationwide population-based retrospective cohort study. Eur J Intern Med. 2015 May;26(4):250-4. doi: 10.1016/j.ejim.2015.02.001. Epub 2015 Feb 18.

  PMID: 25704855 BACKGROUND

• Tantawy AA, Adly AA, El Maaty MG, Amin SA. Subclinical atherosclerosis in young beta-thalassemia major patients. Hemoglobin. 2009;33(6):463-74. doi: 10.3109/03630260903343616.

  PMID: 19958191 BACKGROUND

• Lee WY, Allison MA, Kim DJ, Song CH, Barrett-Connor E. Association of interleukin-6 and C-reactive protein with subclinical carotid atherosclerosis (the Rancho Bernardo Study). Am J Cardiol. 2007 Jan 1;99(1):99-102. doi: 10.1016/j.amjcard.2006.07.070. Epub 2006 Nov 9.

  PMID: 17196470 BACKGROUND

• Guo F, Dong M, Ren F, Zhang C, Li J, Tao Z, Yang J, Li G. Association between local interleukin-6 levels and slow flow/microvascular dysfunction. J Thromb Thrombolysis. 2014 May;37(4):475-82. doi: 10.1007/s11239-013-0974-0.

  PMID: 24242026 BACKGROUND

• Prakash J, Mittal B, Awasthi S, Srivastava N. Association of adiponectin gene polymorphism with adiponectin levels and risk for insulin resistance syndrome. Int J Prev Med. 2015 Apr 8;6:31. doi: 10.4103/2008-7802.154773. eCollection 2015.

  PMID: 25949781 BACKGROUND

• Kriketos AD, Greenfield JR, Peake PW, Furler SM, Denyer GS, Charlesworth JA, Campbell LV. Inflammation, insulin resistance, and adiposity: a study of first-degree relatives of type 2 diabetic subjects. Diabetes Care. 2004 Aug;27(8):2033-40. doi: 10.2337/diacare.27.8.2033.

  PMID: 15277436 BACKGROUND

• Kim DH, Kim C, Ding EL, Townsend MK, Lipsitz LA. Adiponectin levels and the risk of hypertension: a systematic review and meta-analysis. Hypertension. 2013 Jul;62(1):27-32. doi: 10.1161/HYPERTENSIONAHA.113.01453. Epub 2013 May 28.

  PMID: 23716587 BACKGROUND

• Okui H, Hamasaki S, Ishida S, Kataoka T, Orihara K, Fukudome T, Ogawa M, Oketani N, Saihara K, Shinsato T, Shirasawa T, Mizoguchi E, Kubozono T, Ichiki H, Ninomiya Y, Matsushita T, Nakasaki M, Tei C. Adiponectin is a better predictor of endothelial function of the coronary artery than HOMA-R, body mass index, immunoreactive insulin, or triglycerides. Int J Cardiol. 2008 May 7;126(1):53-61. doi: 10.1016/j.ijcard.2007.03.116. Epub 2007 May 2.

  PMID: 17477992 BACKGROUND

• Attar MJ, Mohammadi S, Karimi M, Hosseinnezhad A, Hosseini SH, Eshraghian MR, Jafari N, Rahmani M, Karimi F, Nezhad MK. Association of adiponectin with dietary factors and cardiovascular risk factors in type 2 diabetes mellitus patients. Diabetes Metab Syndr. 2013 Jan-Mar;7(1):3-7. doi: 10.1016/j.dsx.2013.02.027. Epub 2013 Mar 9.

  PMID: 23517787 BACKGROUND

• Ahmad Ibrahim O, Ahmad AB, Nigm DA, Hussien AN, Mohammad Ibrahim WH. Subclinical atherosclerotic predictive value of inflammatory markers in thalassemia intermedia patients. Expert Rev Hematol. 2021 Jul;14(7):669-677. doi: 10.1080/17474086.2021.1959316. Epub 2021 Aug 6.

  PMID: 34296962 DERIVED

Biospecimen

Retention: SAMPLES WITHOUT DNA

Whole blood and serum to be used

MeSH Terms

Conditions

Thalassemia

Interventions

Carotid Intima-Media Thickness

Condition Hierarchy (Ancestors)

Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities

Intervention Hierarchy (Ancestors)

Ultrasonography, Carotid Arteries; Ultrasonography; Diagnostic Imaging; Diagnostic Techniques and Procedures; Diagnosis; Diagnostic Techniques, Cardiovascular; Cardiovascular Physiological Phenomena; Circulatory and Respiratory Physiological Phenomena

Study Design

• Study Type: observational
• Observational Model: CASE CONTROL
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal investigator

Study Record Dates

• First Submitted: May 26, 2017
• First Posted: May 31, 2017
• Study Start: August 1, 2018
• Primary Completion: January 30, 2021
• Study Completion: February 15, 2021
• Last Updated: February 16, 2021

Record last verified: 2021-02

Data Sharing

• IPD Sharing: Will not share

Locations

EG (1)