Plasticizer Exposure and Its Consequences on Health

NCT06512298 | Not Yet Recruiting

• 2 other identifiers: 1716/202310.55776/KLP1811624
• Study Type: observational
• Target: 120
• Locations: 1 country
• Sites: 1

Brief Summary

Plasticizers are chemicals commonly found in many everyday items, from food packaging to medical equipment. Although they are pervasive in our daily lives, researchers still don't have a clear picture of their long-term effects on human health. Evidence suggests that these substances might disrupt various biological functions such as the immune system, the balance of gut bacteria, hormone regulation, and brain processes. While some studies have linked plasticizer exposure to health issues, definitive data from human studies are still lacking. The PEACH study aims to bridge these knowledge gaps by investigating how plasticizers affect human health. The study focuses on understanding how these chemicals are absorbed, distributed, and accumulated in the body across different groups of patients. The investigators are particularly interested in how plasticizers influence gut microbiota and the functionality of immune cells, as well as their effects on neurotransmitters involved in brain function. A combination of patient data, systems biology, and laboratory models will be used to thoroughly assess the biological impacts of plasticizers. Advanced techniques such as mass spectrometry will aid in studying toxicokinetic properties, sequencing technologies will be used to examine immune effects, and radiouptake assays will be employed to explore interactions with neurotransmitter transport. This comprehensive methodology will provide new insights into the effects of both short-term and long-term exposure to plasticizers. The PEACH study introduces innovative methods to the field, aiming to create a robust model for understanding how plasticizer compounds behave in the human body. It employs state-of-the-art techniques to assess the dynamics of these chemicals, marking a significant advancement in environmental health research.

Conditions

Beta-thalassemia; Glioma; Healthy Controls; Transfusion-dependent Beta-Thalassemia; Intracranial Hemorrhages; Toxicity

Keywords

Plasticizer; Transfusion; Systems Biology; Immunology; Microbiome; Neuropharmacology; Pharmacokinetics; Pharmacodynamics; Exposomics

Outcome Measures

Primary Outcomes (1)

• Accumulation of plasticizers in transfused patients

  Plasticizer concentrations (mmol/L) will be measured from the plasma of thalassemia major patients two weeks after the last pRBC-transfusion and compared to plasma levels of healthy controls of beta-thalassemia intermedia/minor patient using MANCOVA. Age, sex and liver/kidney retention will be taken into account as covariates and Tukey HSD or Scheffe tests used for even and uneven group sizes, respectively.

  3 years

Other Outcomes (5)

• Accumulation of plasticizers during storage in pRBC-bags

  1 year

• Plasticizer release into the CSF of ICU-patients

  3 years

• Studying the accumulation of plasticizers within the CSF using a cross-sectional design

  3 years

Study Arms (6)

Transfusion-dependent thalassemia major (TDTM)

Patients suffering from homozygous transfusion-dependent Thalassemia Major.

Thalassemia Minor

Patients suffering from heterozygous transfusion-independent Thalassemia Minor.

Healthy controls

Healthy adult controls without any prevalent substance use (nicotine, alcohol etc.).

Glioma patients

Adults with high/low-grade glioma, a tumor size \> 3cm that require resection with access to the ventricular system without ventricular hemorrhage.

ICU patients

Adults with brain hemorrhage (intracranial, subdural, subarachnoidal), treated with a ventricular shunt.

Patients undergoing diagnostic lumbar-puncture (plastic-naive)

Adults that receive a diagnostic lumbar puncture in an outpatient setting.

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Two study cohorts will be recruited, one to study chronic exposure to plasticizers and another to analyze the "acute" penetration of plasticizers into the central nervous system. In total, 20 TDTM patients, 20 non-transfusion-dependent ß-thalassemia intermedia/minor patients, and 20 healthy controls will be recruited to study chronic exposure. To study the pharmacokinetics of acute transfusion-related accumulation of plasticizers within the CNS, 20 patients undergoing glioma resection, 20 ICU patients suffering from brain hemorrhage without ventricular collapse, and CSF from a cohort of medical-plastic-naïve patients undergoing diagnostic lumbar puncture in the outpatient setting (n=20) will be recruited.

You may not qualify if:

• Thalassemia Intermedia/Minor:
• Healthy adults:
• Glioma patients:
• ICU patients:
• Patients undergoing diagnostic lumbar-puncture:

Sponsors & Collaborators

• Medical University of Vienna: lead
• University of Vienna: collaborator

Study Sites (1)

Medical University of Vienna

Vienna, 1090, Austria

Location

Biospecimen

Retention: SAMPLES WITHOUT DNA

All collected samples will be analyzed for study purposes only. After completion of the study, left material will be destroyed.

MeSH Terms

Conditions

beta-Thalassemia; Glioma; Intracranial Hemorrhages

Condition Hierarchy (Ancestors)

Thalassemia; Anemia, Hemolytic, Congenital; Anemia, Hemolytic; Anemia; Hematologic Diseases; Hemic and Lymphatic Diseases; Hemoglobinopathies; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Neoplasms, Neuroepithelial; Neuroectodermal Tumors; Neoplasms, Germ Cell and Embryonal; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Glandular and Epithelial; Neoplasms, Nerve Tissue; Cerebrovascular Disorders; Brain Diseases; Central Nervous System Diseases; Nervous System Diseases; Vascular Diseases; Cardiovascular Diseases; Hemorrhage; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Lukas Wisgrill, MD, PhD

CONTACT

800-123-4567; lukas.wisgrill@meduniwien.ac.at

Harald Sitte, MD, PhD

CONTACT

800-123-4567; harald.sitte@meduniwien.ac.at

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator, MD

Study Record Dates

• First Submitted: July 6, 2024
• First Posted: July 22, 2024
• Study Start: October 1, 2024
• Primary Completion (Estimated): September 30, 2027
• Study Completion (Estimated): September 30, 2027
• Last Updated: July 24, 2024

Record last verified: 2024-07

Data Sharing

• IPD Sharing: Will not share

Locations

AU (1)