Associations of Exposure to Phthalates With Insulin Resistance and Epigenetic Change | NCT02284477 | Trialant
Unknown statusInterventionalNot ApplicableUpdated Jan 28, 2015
Associations of Exposure to Phthalates With Insulin Resistance and Epigenetic Change
Associations of Exposure to Phthalates With Insulin Resistance and Epigenetic Change
ClinicalTrials.gov ID
NCT02284477
Lead Sponsor
Seoul National University HospitalOTHER
Overall Status
Unknown status
Study Type
Interventional
Phase
Not Applicable
Enrollment
60Estimated
Last Update Posted
Jan 28, 2015Estimated
Start Date
Jan 2015
Primary Completion Date
Apr 2015Estimated
Completion Date
Apr 2015Estimated
Official Title
Associations of Exposure to Phthalates With Insulin Resistance and Epigenetic Change
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.
Insulin Resistance
Decreased Pulmonary Function
non- PVC containing packing materials
PVC containing packing materials
Ages Eligible for Study
Adult (18-64)Older Adult (65+)
Sexes Eligible for Study
All
Accepts Healthy Volunteers
Yes
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 Purpose
Basic Science
Allocation
Randomized
Interventional Model
Crossover Assignment
Masking
Triple
Sanghyuk Bae, MD, PhDContact
sanghyukbae@snu.ac.kr+8227408576
Department of Preventive Medicine, College of Medicine, Seoul National UniversityRecruiting