Clinical trial NCT02284477: Associations of Exposure to Phthalates With Insulin Resistance and Epigenetic Change
Official title: Associations of Exposure to Phthalates With Insulin Resistance and Epigenetic Change
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Insulin Resistance
Decreased Pulmonary Function
Keywords: Insulin resistance
Pulmonary function
Phthalates
Lead sponsor: Seoul National University Hospital
Sponsor class: OTHER
First posted: 2014-11-06
Enrollment: 60
Sex: ALL
Minimum age (years): 60
Maximum age (years): 85
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.


Eligibility criteria: 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.

Primary outcomes:
measure: Increase of insulin resistance assessed by HOMA (Homeostatic model assessment)
timeFrame: average 14 hours after consumption of assigned food and beverage
Secondary outcomes:
measure: Change of DNA methylation assessed by Percent DNA methylation
timeFrame: average 14 hours after consumption of assigned food and beverage
measure: Decrease of lung function assessed by FEV1
timeFrame: average 14 hours after consumption of assigned food and beverage
measure: Decrease of lung function assessed by FVC
timeFrame: average 14 hours after consumption of assigned food and beverage
measure: Decrease of lung function assessed by FEV1/FVC
timeFrame: average 14 hours after consumption of assigned food and beverage
measure: Decrease of lung function assessed by FEF25-75
timeFrame: average 14 hours after consumption of assigned food and beverage
measure: Increased exposure to Phthalate assessed by urinary concentration of metabolites
timeFrame: average 14 hours after consumption of assigned food and beverage
Other outcomes:
Locations:
city: Seoul
country: Korea, Republic of
facility: Department of Preventive Medicine, College of Medicine, Seoul National University
Study officials:
affiliation: College of Medicine, Seoul National Unveirsity
name: Yun-Chul Hong, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: Stahlhut RW, van Wijngaarden E, Dye TD, Cook S, Swan SH. Concentrations of urinary phthalate metabolites are associated with increased waist circumference and insulin resistance in adult U.S. males. Environ Health Perspect. 2007 Jun;115(6):876-82. doi: 10.1289/ehp.9882. Epub 2007 Mar 14.
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citation: Kim JH, Hong YC. HSP70-hom gene polymorphisms modify the association of diethylhexyl phthalates with insulin resistance. Environ Mol Mutagen. 2014 Dec;55(9):727-34. doi: 10.1002/em.21884. Epub 2014 Jul 7.
citation: Kim JH, Park HY, Bae S, Lim YH, Hong YC. Diethylhexyl phthalates is associated with insulin resistance via oxidative stress in the elderly: a panel study. PLoS One. 2013 Aug 19;8(8):e71392. doi: 10.1371/journal.pone.0071392. eCollection 2013.
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