Oxidative Stress in Patient With Haemoglobinopathy and Affect it of Endocrine SystemNCT05586932
Oxidative Stress and Iron Overload in Patient With Abnormal Haemoglobinopathy
An observational study of Oxidative Stress in Patient With Haemoglobinopathy and Affect it of Endocrine System, run by Assiut University.
Trial summary
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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Oxidative Stress in Patient With Haemoglobinopathy and Affect it of Endocrine System
- How many people
- 25 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2022to 1 Jan 2024
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- Adult, Older adult
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
Who may be able to join
- 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
Who cannot join
- age under 18 years.
- patient diagnosed with DM or those taking pharmacological agents such as steroids, insulin and lipid lowering drugs
Trial locations and contacts
No sites are listed yet.
About this study
Official title: 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.
Read the 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
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 1 year
Secondary outcomes (1)
Using of MDA level as a marker of oxidative stress
Malondialdehyde as a marker of oxidative stress
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Oct 2022
- Study start1 Dec 2022 (estimated)
- Primary completion1 Dec 2023 (estimated)
- Study completion1 Jan 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Oxidative Stress in Patient With Haemoglobinopathy and Affect it of Endocrine SystemStudies of the same condition, open and under way.
- More trials run by Assiut UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Case-control
- Time perspective
- Other
- Enrolment
- 25 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Assiut University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Samar Gebril Mohamed Mahdy, Assiut University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05586932
- Sponsor's protocol ID
- OxidativestressinabnormalHb
- Status last verified
- Oct 2022
- First submitted
- 16 Oct 2022
- Last updated
- 19 Oct 2022
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Oct 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effect of Iron Overload, Oxidative Stress and Dyslipidemia on Glucose Level and Thyroid Function in Patients With Abnormal Hemoglobinopathy
- ClinicalTrials.gov ID
- NCT05586932
- Acronym / sponsor ID
- OxidativestressinabnormalHb
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 25 participants (estimated)
- Lead sponsor
- Assiut UniversityUniversity, hospital or other
- Study start
- 1 Dec 2022 (estimated)
- Primary completion
- 1 Dec 2023 (estimated)
- Study completion
- 1 Jan 2024 (estimated)
- First posted
- 19 Oct 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
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 design
- Observational model
- Case-control
- Time perspective
- Other
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Age groups
- Adult, Older adult
- 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
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (2 listed)
- age under 18 years.
- patient diagnosed with DM or those taking pharmacological agents such as steroids, insulin and lipid lowering drugs
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
correlation between oxidative stress and endocrine dysfunction in patients with hemoglubinopathy
Time frame: 1 year
1. The effects of iron overload and oxidative stress and dyslipidemia on glucose level and thyroid function in patients with abnormal hemoglobinopathy.
1 secondary outcome
Using of MDA level as a marker of oxidative stress
Time frame: 1 year
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Oct 2022.
- Endocrinopathies complicating transfusion-dependent hemoglobinopathyLink provided by the sponsor.
- Pituitary Iron Deposition and Endocrine Complications in Patients with β-Thalassemia: From Childhood to AdulthoodLink provided by the sponsor.
- Sickle Cell Disease: Role of Oxidative Stress and Antioxidant TherapyLink provided by the sponsor.
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
An observational study of Oxidative Stress in Patient With Haemoglobinopathy and Affect it of Endocrine System, run by Assiut University.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 19 Oct 2022. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Samar Gebril Mahdy, Intern (+0201015714015, samargebril654321@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
correlation between oxidative stress and endocrine dysfunction in patients with hemoglubinopathy (time frame: 1 year). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 19 Oct 2022.