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Status unknownNCT05586932Updated Oct 19, 2022

Oxidative Stress and Iron Overload in Patient With Abnormal Haemoglobinopathy

An observational study in Oxidative Stress in Patient With Haemoglobinopathy and Affect it of Endocrine System, sponsored by Assiut University. Status unknown. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2022-10-19.

Sponsored by Assiut University · Observational

The sponsor has not verified this record recently (last verified Oct 2022), so the status shown — last known as Not yet recruiting — may be out of date.
Study type
Observational
Model
Case-control
Time perspective
Other
Enrollment
25
Ages
18 Years to 75 Years
Sex
All
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Study 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 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

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Conditions studied

  • Oxidative Stress in Patient With Haemoglobinopathy and Affect it of Endocrine System
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In context

Lead sponsor

Assiut University is the lead sponsor of 5,050 studies on the registry; 2,174 are open to participants now.

Of its 14 completed or terminated interventional studies of FDA-regulated products, 0 (0%) have results posted.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
18 Years to 75 Years
Sexes eligible
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

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

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

Exclusion Criteria:

  • age under 18 years.
  • patient diagnosed with DM or those taking pharmacological agents such as steroids, insulin and lipid lowering drugs
05

Study design

Observational model
Case-control
Time perspective
Other
Enrollment
25 participants (estimated)
Patient registry
No
06

What researchers measure

Primary outcomes

  1. correlation between oxidative stress and endocrine dysfunction in patients with hemoglubinopathy

    1. The effects of iron overload and oxidative stress and dyslipidemia on glucose level and thyroid function in patients with abnormal hemoglobinopathy.

    Time frame: 1 year

Secondary outcomes

  1. Using of MDA level as a marker of oxidative stress

    Malondialdehyde as a marker of oxidative stress

    Time frame: 1 year

07

Study locations

No study locations are listed for this record.

08

References and documents

09

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reached

Start is estimated for Dec 2022; primary completion for Dec 2023, 12 months later.

How these figures are worked out, and which studies are left out of them.

Registered
Oct 16, 2022
First posted
Oct 19, 2022
StartEst.
Dec 1, 2022
Primary completionEst.
Dec 1, 2023
CompletionEst.
Jan 1, 2024
Last update
Oct 19, 2022
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on Oct 19, 2022, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
10

Registry details

Key details

Study ID
NCT05586932
Lead sponsor
Assiut University
Responsible party
Samar Gebril Mohamed Mahdy (Doctor, Assiut University) — Principal investigator
First posted
Oct 19, 2022
Start date
Dec 1, 2022 (estimated)
Primary completion
Dec 1, 2023 (estimated)
Completion
Jan 1, 2024 (estimated)
Last update
Oct 19, 2022

Study contacts

Samar Gebril Mahdy, Intern
Contact
samargebril654321@gmail.com
+0201015714015

Oversight

FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in Oct 2022. You cannot join it, but the record below documents what was studied.

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