Prognostic Impacts of Lipid Profile and BMI in Adult AML (AML/BMI)

Prognostic Impacts of Lipid Profile and Body Mass Index in Adult Acute Myeloid Leukemia Patients Treated With Intensive Induction Chemotherapy

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.

Study Overview

• Status: Not yet recruiting
• Conditions: BMI; Lipid Profile; Induction Chemotherapy; AML (Acute Myeloid Leukemia)

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

• Study Type: Observational
• Enrollment (Estimated): 200

Contacts and Locations

• Study Contact: Name: Mohammad S Mohammad, MBBS; Phone Number: +201095027359; Email: mohamed.17289893@med.aun.edu.eg
• Study Contact Backup: Name: Amira H Abdel Aziz, MD; Phone Number: +201092094687; Email: amirahassan13@aun.edu.eg

Study Locations

• Egypt
  • Asyut Governorate
    • Asyut, Asyut Governorate, Egypt, 71511
      • Assiut University Hospitals
      • Contact: Gamal A Badr, MD; Phone Number: +208822080150; Email: vp_grad@aun.edu.eg

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Adult patients(≥18yearsold) newly diagnosed with AML.

Description

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.

Study Plan

How is the study designed?

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Changes in lipid profile	Observing changes of lipid profile (total cholesterol, triglycerides, HDL-C, LDL-C) measured at baseline and after completion of induction therapy	Pre-induction to post-induction (day 28-35).
Changes in Body Mass Index	Observing changes of Body Mass Index (measured as weight in kilograms divided by squared height in meters) measured at baseline and after completion of induction therapy	Pre-induction to post-induction (day 28-35)

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Association of lipid profile changes with treatment response	Observing association of lipid profile changes with treatment response (complete remission, partial response, failure), occurrence of treatment-related complications (e.g., infections, tumor lysis syndrome), and duration of hospitalization.	Pre-induction to post-induction (day 28-35).
Association of Body Mass Index changes with treatment response	Observing association of Body Mass Index (measures as weight in kilograms divided by squared height in meters) changes with treatment response (complete remission, partial response, failure), occurrence of treatment-related complications (e.g., infections, tumor lysis syndrome), and duration of hospitalization.	Pre-induction to post-induction (day 28-35)

Collaborators and Investigators

• Sponsor: Assiut University
• Investigators: Principal Investigator: Mohammad S Mohammad, MBBS, Assiut University

Study record dates

Study Major Dates

• Study Start (Estimated): November 15, 2025
• Primary Completion (Estimated): December 15, 2026
• Study Completion (Estimated): March 15, 2027

Study Registration Dates

• First Submitted: August 15, 2025
• First Submitted That Met QC Criteria: August 23, 2025
• First Posted (Estimated): August 27, 2025

Study Record Updates

• Last Update Posted (Estimated): August 27, 2025
• Last Update Submitted That Met QC Criteria: August 23, 2025
• Last Verified: August 1, 2025

More Information

Terms related to this study

• Keywords: AML; Adult; Lipid profile; BMI; Induction chemotherapy
• Additional Relevant MeSH Terms: Neoplasms; Neoplasms by Histologic Type; Hematologic Diseases; Leukemia, Myeloid; Leukemia; Hemic and Lymphatic Diseases; Leukemia, Myeloid, Acute
• Other Study ID Numbers: 04-2025-201323

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO