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Associations of Exposure to Phthalates With Insulin Resistance and Epigenetic Change

Primary Purpose

Insulin Resistance, Decreased Pulmonary Function

Status

Unknown status

Phase

Not Applicable

Locations

Korea, Republic of

Study Type

Interventional

Intervention

non- PVC containing packing materials

PVC containing packing materials

About this trial

This is an interventional basic science trial for Insulin Resistance focused on measuring Insulin resistance, Pulmonary function, Phthalates

Eligibility Criteria

60 Years - 85 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

Department of Preventive Medicine, College of Medicine, Seoul National UniversityRecruiting

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

No Intervention

Arm Label

non- PVC containing packing materials

PVC containing packing materials

Only lunch and dinner

Arm Description

Participants will be provided food for lunch and dinner with 360mL apple juice which was stored in glass bottle for 24 hours in 4 ℃. After 1 week, participant will cross over to other intervention.

Participants will be provided food for lunch and dinner with 360mL apple juice which was stored in PVC blood bag for 24 hours in 4 ℃. After 1 week, participant will cross over to other intervention.

Participant received food for lunch and dinner After 1 week, participant get over to each experimental arms.

Outcomes

Primary Outcome Measures

Increase of insulin resistance assessed by HOMA (Homeostatic model assessment)

Secondary Outcome Measures

Change of DNA methylation assessed by Percent DNA methylation

Decrease of lung function assessed by FEV1

Decrease of lung function assessed by FVC

Decrease of lung function assessed by FEV1/FVC

Decrease of lung function assessed by FEF25-75

Increased exposure to Phthalate assessed by urinary concentration of metabolites

Full Information

NCT ID

NCT02284477

First Posted

October 30, 2014

Last Updated

January 27, 2015

Sponsor

Seoul National University Hospital

1. Study Identification

Unique Protocol Identification Number

NCT02284477

Brief Title

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

2. Study Status

Record Verification Date

October 2014

Overall Recruitment Status

Unknown status

Study Start Date

January 2015 (undefined)

Primary Completion Date

April 2015 (Anticipated)

Study Completion Date

April 2015 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Seoul National University Hospital

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Insulin Resistance, Decreased Pulmonary Function

Keywords

Insulin resistance, Pulmonary function, Phthalates

7. Study Design

Primary Purpose

Basic Science

Study Phase

Not Applicable

Interventional Study Model

Crossover Assignment

Masking

ParticipantCare ProviderOutcomes Assessor

Allocation

Randomized

Enrollment

60 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title

non- PVC containing packing materials

Arm Type

Experimental

Arm Description

Participants will be provided food for lunch and dinner with 360mL apple juice which was stored in glass bottle for 24 hours in 4 ℃. After 1 week, participant will cross over to other intervention.

Arm Title

PVC containing packing materials

Arm Type

Experimental

Arm Description

Arm Title

Only lunch and dinner

Arm Type

No Intervention

Arm Description

Participant received food for lunch and dinner After 1 week, participant get over to each experimental arms.

Intervention Type

Other

Intervention Name(s)

non- PVC containing packing materials

Other Intervention Name(s)

Beverage stored in glass bottle

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

PVC containing packing materials

Other Intervention Name(s)

Beverage stored in blood bag

Intervention Description

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

Primary Outcome Measure Information:

Title

Increase of insulin resistance assessed by HOMA (Homeostatic model assessment)

Time Frame