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Associations of Exposure to Phthalates With Insulin Resistance and Epigenetic Change

NCT02284477 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2015-01-28

No results posted yet for this study

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.

Conditions

Interventions

OTHER

non- PVC containing packing materials

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

OTHER

PVC containing packing materials

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

Sponsors & Collaborators

  • Seoul National University Hospital

    lead OTHER

Principal Investigators

  • Yun-Chul Hong, MD, PhD · College of Medicine, Seoul National Unveirsity

Study Design

Allocation
RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
TRIPLE
Model
CROSSOVER

Eligibility

Min Age
60 Years
Max Age
85 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-01-31
Primary Completion
2015-04-30
Completion
2015-04-30

Countries

  • South Korea

Study Locations

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Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02284477 on ClinicalTrials.gov