Oxidative Stress and Iron Overload in Patient With Abnormal Haemoglobinopathy

The Effect of Iron Overload, Oxidative Stress and Dyslipidemia on Glucose Level and Thyroid Function in Patients With Abnormal Hemoglobinopathy

The effects of iron overload and oxidative stress and dyslipidemia on glucose level and thyroid function in patients with abnormal hemoglobinopathy. 2- Evaluation of MDA level as a marker of oxidative stress.

Study Overview

• Status: Not yet recruiting
• Conditions: Oxidative Stress in Patient With Haemoglobinopathy and Affect it of Endocrine System

Detailed Description

Severe anemia due to defect in the synthesis of hemoglobin and hemolysis can endanger the life of β- thalassemia major (β-TM) patients and sickle cell anemia; therefore, the span and patient's quality of life is highly dependent on regular blood transfusion. Nonetheless, blood transfusion causes iron accumulation in the patients. Excess iron deposits in vital organs, such as liver, heart and endocrine glands, result in their malfunction. Endocrinopathies account as one of the most common iron overload complications. Oxidative stress is a major mechanism contributing to the progression of the disease in TDT. Iron overload enhances oxidative stress in patients with TDT. Iron is recognized to be a catalyst in developing reactive oxygen species (ROS).

MDA is an eosinophilic enol compound that reacts with the structural and functional cellular protein to generate toxic lipoxidation end product destined for cellular damage of the affected organs. It is used as a sensitive biomarker for oxidative stress. Disturbances in serum lipids and carbohydrates homoeostasis as well as OS were documented in β-TM and sickle cell anemia. Increase in serum levels total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C) and decrease in high-density lipoprotein cholesterol (HDL-C) are the well-known causative factors and predictors of CHD development and endocrine abnormality

• Study Type: Observational
• Enrollment (Anticipated): 25

Contacts and Locations

• Study Contact: Name: Samar Gebril Mahdy, Intern; Phone Number: +0201015714015; Email: samargebril654321@gmail.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 75 years (Adult, Older Adult)
• Accepts Healthy Volunteers: N/A
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

The study will be done in Assiut University Hospital on 50 cases as Group (A): cases diagnosed as beta thalassemia major Group (B): healthy individuals (control)

All patients will be subjected to full clinical history, examination and investigation. -investigation will include:

• laboratory test:
• CBC. -TSH, T4, T3. -serum oxidative stress marker (MDA).
• glucose level.
• cholesterol, triglycerides, HDl, LDL

Description

Inclusion Criteria:

- age 18 and above.

-patients diagnosed according to physical examination and results of laboratory tests as beta thalassemia major. -patient under gradual blood transfusion and iron chelating therapy. -Gender and age matched healthy controls with normal serum lipid, glucose level and thyroid function will enrolled in this study as the control group

Exclusion Criteria:

• age under 18 years.
• patient diagnosed with DM or those taking pharmacological agents such as steroids, insulin and lipid lowering drugs

Study Plan

How is the study designed?

Design Details

• Observational Models: Case-Control
• Time Perspectives: Other

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
correlation between oxidative stress and endocrine dysfunction in patients with hemoglubinopathy	The effects of iron overload and oxidative stress and dyslipidemia on glucose level and thyroid function in patients with abnormal hemoglobinopathy.	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Using of MDA level as a marker of oxidative stress	Malondialdehyde as a marker of oxidative stress	1 year

Collaborators and Investigators

• Sponsor: Assiut University

Publications and helpful links

Helpful Links

• Endocrinopathies complicating transfusion-dependent hemoglobinopathy
• Pituitary Iron Deposition and Endocrine Complications in Patients with β-Thalassemia: From Childhood to Adulthood
• Sickle Cell Disease: Role of Oxidative Stress and Antioxidant Therapy

Study record dates

Study Major Dates

• Study Start (Anticipated): December 1, 2022
• Primary Completion (Anticipated): December 1, 2023
• Study Completion (Anticipated): January 1, 2024

Study Registration Dates

• First Submitted: October 16, 2022
• First Submitted That Met QC Criteria: October 16, 2022
• First Posted (Actual): October 19, 2022

Study Record Updates

• Last Update Posted (Actual): October 19, 2022
• Last Update Submitted That Met QC Criteria: October 16, 2022
• Last Verified: October 1, 2022

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Metabolic Diseases; Hematologic Diseases; Genetic Diseases, Inborn; Iron Metabolism Disorders; Iron Overload; Hemoglobinopathies
• Other Study ID Numbers: OxidativestressinabnormalHb

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No