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Associations of Exposure to Phthalates With Insulin Resistance and Epigenetic Change

Associations of Exposure to Phthalates With Insulin Resistance and Epigenetic Change

Status
UNKNOWN
Phases
NA
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT02284477
Enrollment
60
Registered
2014-11-06
Start date
2015-01-31
Completion date
2015-04-30
Last updated
2015-01-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Decreased Pulmonary Function, Insulin Resistance

Keywords

Insulin resistance, Pulmonary function, Phthalates

Brief summary

* Phthalate is an endocrine disrupting chemical, which works as an anti-androgenic agent. * Phthalate is mainly used as PVC plasticizer and easily found in commonly used products such as electronic device, paint, lubricant, surfactant, medical supplies, spray etc. Especially, PVC blood bag used for blood transfusion have been reported to have high level of phthalate concentration. * Previous studies reported that urinary concentration of phthalate metabolites and HOMA (Homeostatic model assessment, indicator of insulin resistance) has positive association. * Previous studies also reported negative associations between urinary phthalate concentration and pulmonary function. * Exposure to phthalates occurs mainly through oral route. Food wrapping with phthalate containing package material is expected to be one of the major contributor for phthalate exposure. * In this present trial, the investigators are to examine whether increased phthalate exposure by consuming beverage stored in PVC containing packing materials actually effect insulin resistance, pulmonary function and epigenetic feature. * For this aim, the investigators will conduct a cross-over trial.

Interventions

OTHERnon- PVC containing packing materials

Beverage which was stored in glass bottle for 24 hours in 4 ℃.

OTHERPVC containing packing materials

Beverage which was stored in PVC blood bag for 24 hours in 4 ℃.

Sponsors

Seoul National University Hospital
Lead SponsorOTHER

Study design

Allocation
RANDOMIZED
Intervention model
CROSSOVER
Primary purpose
BASIC_SCIENCE
Masking
TRIPLE (Subject, Caregiver, Outcomes Assessor)

Eligibility

Sex/Gender
ALL
Age
60 Years to 85 Years
Healthy volunteers
Yes

Inclusion criteria

* Participants who understand aim of this study and who provided informed consent

Exclusion criteria

* Who did not provided informed consent * Person who are undergoing or planning to take a treatment due to liver, nervous system, respiratory system, hematologic, oncologic, psychiatric, cardiovascular(angina pectoris, myocardial infarction, stroke etc), endocrinal(Diabetes mellitus, thyroid disease) disorders.

Design outcomes

Primary

MeasureTime frame
Increase of insulin resistance assessed by HOMA (Homeostatic model assessment)average 14 hours after consumption of assigned food and beverage

Secondary

MeasureTime frame
Decrease of lung function assessed by FEV1average 14 hours after consumption of assigned food and beverage
Decrease of lung function assessed by FVCaverage 14 hours after consumption of assigned food and beverage
Change of DNA methylation assessed by Percent DNA methylationaverage 14 hours after consumption of assigned food and beverage
Decrease of lung function assessed by FEF25-75average 14 hours after consumption of assigned food and beverage
Increased exposure to Phthalate assessed by urinary concentration of metabolitesaverage 14 hours after consumption of assigned food and beverage
Decrease of lung function assessed by FEV1/FVCaverage 14 hours after consumption of assigned food and beverage

Countries

South Korea

Contacts

Primary ContactSanghyuk Bae, MD, PhD
sanghyukbae@snu.ac.kr+8227408576

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026