Prognostic Impacts of Lipid Profile and BMI in Adult AML

NCT ID: NCT07143877

Last Updated: 2025-08-27

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Total Enrollment: 200 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2025-11-15
• Study Completion Date: 2027-03-15

Brief Summary

The goal of this observational study is to evaluate the changes in lipid profile parameters (total cholesterol, triglycerides, HDL-C, and LDL-C) in adult AML patients before and after intensive induction chemotherapy. The main questions it aims to answer are:

• Are there correlations between metabolic changes (in lipid profile and BMI) and treatment outcomes, including remission status and incidence of chemotherapy-related complications?
• Can the baseline lipid profile and BMI serve as prognostic markers for response to induction chemotherapy.?

Participants will be observed before and after induction chemotherapy regarding their lipid profile, and BMI, observing any correlations between the different results with any complications, and with remission status.

Detailed Description

Acute Myeloid Leukemia is a heterogeneous hematological malignancy characterized by clonal proliferation and accumulation of immature myeloid cells in the bone marrow and peripheral blood. It predominantly affects adults and often requires aggressive treatment in the form of intensive induction chemotherapy, typically based on cytarabine and anthracyclines.

The metabolic state of patients with AML including their lipid profile and body mass index, can influence both the disease course and response to treatment. Chemotherapy and its associated complications-such as infections, inflammation, and nutritional deficiencies-may lead to profound alterations in lipid metabolism and body composition.

Dyslipidemia may also emerge as a side effect of supportive medications like corticosteroids or parenteral nutrition. BMI is a simple anthropometric indicator of nutritional and general health status. Both undernutrition and obesity have been linked to adverse outcomes in cancer patients, including increased treatment-related toxicity and inferior survival rates. Similarly, changes in lipid parameters-such as total cholesterol, triglycerides, HDL, and LDL-may reflect systemic inflammation or hepatic dysfunction during treatment.

Given the rising interest in the metabolic implications of chemotherapy, it becomes imperative to investigate how intensive treatment affects these parameters in AML patients. However, there is a paucity of local data, particularly in Egyptian settings such as Assiut University Hospitals, where nutritional profiles and healthcare practices may differ from global norms.

Studying the lipid profile and BMI before and after induction chemotherapy may help identify at-risk patients, guide supportive care, and contribute to personalized treatment planning. This research aims to bridge the gap by exploring these metabolic indicators in adult AML patients managed at the Hematology Department of Assiut University Hospitals.

Study tools include patients' demographics including (age, sex, residence, occupation and age at time of diagnosis), detailed clinical history and physical examination, recording of demographic data (age and gender) and disease characteristics (AML subtype). Documentation of weight and height to calculate BMI before and after induction chemotherapy. Metabolic confounders (e.g.DM and Thyroid diseases) could be ruled out by History and examination. Laboratory tests would include Complete lipid profile (total cholesterol, triglycerides, HDL-C and LDL-C) measured at baseline and after completion of induction therapy. Complete blood count (CBC), liver function tests (LFTs), renal function tests, bone marrow aspirate for AML diagnosis and monitoring, and medication received

Conditions

AML (Acute Myeloid Leukemia); BMI; Lipid Profile; Induction Chemotherapy

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: PROSPECTIVE

Eligibility Criteria

Inclusion Criteria

• Adult patients (≥18yearsold) newly diagnosed with AML.
• Patients eligible for intensive induction chemotherapy.
• Patients who have given informed consent to participate in the study.

Exclusion Criteria

• Patients with secondary or relapsed AML.
• Patients currently using lipid-lowering medications (e.g., statins).
• Patients with known endocrine or metabolic disorders affecting BMI or lipid profile (e.g., uncontrolled diabetes, hypothyroidism, Cushing's syndrome).
• Pregnant or lactating women.
• Patients unwilling or unable to complete the study protocol.
• Patients with M3 subtype of AML.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Assiut University

OTHER

Sponsor Role: lead

Responsible Party

Mohammad Sayed Mohammad Bakheet

Resident of internal medicine department

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Mohammad S Mohammad, MBBS

Role: PRINCIPAL_INVESTIGATOR

Assiut University

Locations

Assiut university Hospitals

Asyut, Asyut Governorate, Egypt

Countries

Egypt

Central Contacts

Mohammad S Mohammad, MBBS

Role: CONTACT

mohamed.17289893@med.aun.edu.eg

+201095027359

Amira H Abdel Aziz, MD

Role: CONTACT

amirahassan13@aun.edu.eg

+201092094687

Facility Contacts

Gamal A Badr, MD

Role: primary

vp_grad@aun.edu.eg

+208822080150

Other Identifiers

04-2025-201323

Identifier Type: -

Identifier Source: org_study_id