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NCT Number: NCT07143877

Prognostic Impacts of Lipid Profile and BMI in Adult AML

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.

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Key information

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

About this study

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

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

Primary outcomes

  1. Changes in lipid profile

    Time frame: Pre-induction to post-induction (day 28-35).

    Observing changes of lipid profile (total cholesterol, triglycerides, HDL-C, LDL-C) measured at baseline and after completion of induction therapy

  2. Changes in Body Mass Index

    Time frame: Pre-induction to post-induction (day 28-35)

    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

Secondary outcomes

  1. Association of lipid profile changes with treatment response

    Time frame: Pre-induction to post-induction (day 28-35).

    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.

  2. Association of Body Mass Index changes with treatment response

    Time frame: Pre-induction to post-induction (day 28-35)

    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.

Study contacts

Contact information is provided by the study sponsor or research team.

Amira H Abdel Aziz, MD

CONTACT

[email protected]

+201092094687

Mohammad S Mohammad, MBBS

CONTACT

[email protected]

+201095027359

Sponsors and collaborators

Lead sponsor

Assiut University

Other

Registry information

Official study title

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

Acronym: AML/BMI

Important dates

Study start
2025
Primary completion
2026
Study completion
2027
First posted
Aug 27, 2025
Registry last updated
Aug 27, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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