Associations of Exposure to Phthalates With Insulin Resistance and Epigenetic Change

Insulin Resistance Clinical Trial

Official title:

Associations of Exposure to Phthalates With Insulin Resistance and Epigenetic Change

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02284477
• Other study ID #: 2014-2075
• Status: Recruiting
• Phase: N/A
• First received: October 30, 2014
• Last updated: January 27, 2015
• Start date: January 2015
• Est. completion date: April 2015

Study information

• Verified date: October 2014
• Source: Seoul National University Hospital
• Contact: Sanghyuk Bae, MD, PhD
• Phone: +8227408576
• Email: sanghyukbae[@]snu.ac.kr
• Is FDA regulated: No
• Health authority: Republic of Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 60
• Est. completion date: April 2015
• Est. primary completion date: April 2015
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 60 Years to 85 Years

Eligibility

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.

Study Design

Allocation: Randomized, Intervention Model: Crossover Assignment, Masking: Double Blind (Subject, Caregiver, Outcomes Assessor), Primary Purpose: Basic Science

Related Conditions & MeSH terms

• Decreased Pulmonary Function
• Insulin Resistance
• Respiratory Insufficiency

Intervention

Other:
• non- PVC containing packing materials
Beverage which was stored in glass bottle for 24 hours in 4 ?.
• PVC containing packing materials
Beverage which was stored in PVC blood bag for 24 hours in 4 ?.

Locations

Country	Name	City	State
Korea, Republic of	Department of Preventive Medicine, College of Medicine, Seoul National University	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Seoul National University Hospital

Country where clinical trial is conducted

Korea, Republic of, 

References & Publications (9)

Hoppin JA, Tolbert PE, Flagg EW, Blair A, Zahm SH. Use of a life events calendar approach to elicit occupational history from farmers. Am J Ind Med. 1998 Nov;34(5):470-6. — View 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. — View 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. — View Citation

Manikkam M, Tracey R, Guerrero-Bosagna C, Skinner MK. Plastics derived endocrine disruptors (BPA, DEHP and DBP) induce epigenetic transgenerational inheritance of obesity, reproductive disease and sperm epimutations. PLoS One. 2013;8(1):e55387. doi: 10.1371/journal.pone.0055387. Epub 2013 Jan 24. — View Citation

Rudel RA, Gray JM, Engel CL, Rawsthorne TW, Dodson RE, Ackerman JM, Rizzo J, Nudelman JL, Brody JG. Food packaging and bisphenol A and bis(2-ethyhexyl) phthalate exposure: findings from a dietary intervention. Environ Health Perspect. 2011 Jul;119(7):914-20. doi: 10.1289/ehp.1003170. Epub 2011 Mar 30. — View Citation

Singh S, Li SS. Epigenetic effects of environmental chemicals bisphenol A and phthalates. Int J Mol Sci. 2012;13(8):10143-53. doi: 10.3390/ijms130810143. Epub 2012 Aug 15. Review. — View 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. Epub 2007 Mar 14. Erratum in: Environ Health Perspect. 2007 Sep;115(9):A443. — View Citation

van der Mei IA, Blizzard L, Ponsonby AL, Dwyer T. Validity and reliability of adult recall of past sun exposure in a case-control study of multiple sclerosis. Cancer Epidemiol Biomarkers Prev. 2006 Aug;15(8):1538-44. — View Citation

Zahm SH, Colt JS, Engel LS, Keifer MC, Alvarado AJ, Burau K, Butterfield P, Caldera S, Cooper SP, Garcia D, Hanis C, Hendrikson E, Heyer N, Hunt LM, Krauska M, MacNaughton N, McDonnell CJ, Mills PK, Mull LD, Nordstrom DL, Outterson B, Slesinger DP, Smith MA, Stallones L, Stephens C, Sweeney A, Sweitzer K, Vernon SW, Blair A. Development of a life events/icon calendar questionnaire to ascertain occupational histories and other characteristics of migrant farmworkers. Am J Ind Med. 2001 Nov;40(5):490-501. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Increase of insulin resistance assessed by HOMA (Homeostatic model assessment)		average 14 hours after consumption of assigned food and beverage	No
Secondary	Change of DNA methylation assessed by Percent DNA methylation		average 14 hours after consumption of assigned food and beverage	No
Secondary	Decrease of lung function assessed by FEV1		average 14 hours after consumption of assigned food and beverage	No
Secondary	Decrease of lung function assessed by FVC		average 14 hours after consumption of assigned food and beverage	No
Secondary	Decrease of lung function assessed by FEV1/FVC		average 14 hours after consumption of assigned food and beverage	No
Secondary	Decrease of lung function assessed by FEF25-75		average 14 hours after consumption of assigned food and beverage	No
Secondary	Increased exposure to Phthalate assessed by urinary concentration of metabolites		average 14 hours after consumption of assigned food and beverage	No