Insulin ResistanceNCT02284477
Associations of Exposure to Phthalates With Insulin Resistance and Epigenetic Change
A study testing non- PVC containing packing materials and PVC containing packing materials in people with Insulin Resistance and Decreased Pulmonary Function, run by Seoul National University Hospital at 1 site in South Korea.
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. Read more about this study
- Who is it for?
- Ages 60 to 85 yearsHealthy volunteers can take part
- Conditions the study is for
- Insulin Resistance, Decreased Pulmonary Function
- What is being tested?
- non- PVC containing packing materials and PVC containing packing materials
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteSouth Korea
- Study dates
- Jan 2015to Apr 2015
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 60 to 85 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Who may be able to join
- Participants who understand aim of this study and who provided informed consent
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country.
South Korea1 site, 1 recruiting
- Recruiting
Department of Preventive Medicine, College of Medicine, Seoul National University
Seoul, 110-799
Sanghyuk Bae, MD, 8227408572, sanghyukbae@snu.ac.kr
Yun-Chul Hong, MD, PhD
About this study
- 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
- Insulin Resistance, Decreased Pulmonary Function
- Being tested
- non- PVC containing packing materials, PVC containing packing materials
- Keywords
- Insulin resistance, Pulmonary function, Phthalates
- Medical subject headings
- Insulin Resistance, Respiratory Insufficiency
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
non- PVC containing packing materialsOther
Also called Beverage stored in glass bottle
Beverage which was stored in glass bottle for 24 hours in 4 ℃.
PVC containing packing materialsOther
Also called Beverage stored in blood bag
Beverage which was stored in PVC blood bag for 24 hours in 4 ℃.
| Study group | Role | What they receive |
|---|---|---|
| non- PVC containing packing materials | Experimental | 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. Receives: Other: non- PVC containing packing materials |
| PVC containing packing materials | Experimental | 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. Receives: Other: PVC containing packing materials |
| Only lunch and dinner | No intervention | Participant received food for lunch and dinner After 1 week, participant get over to each experimental arms. |
What is being measured
The primary outcome is the main question the study is designed to answer.
Increase of insulin resistance assessed by HOMA (Homeostatic model assessment)
Measured: average 14 hours after consumption of assigned food and beverage
Secondary outcomes (6)
Change of DNA methylation assessed by Percent DNA methylation
Measured: average 14 hours after consumption of assigned food and beverage
Decrease of lung function assessed by FEV1
Measured: average 14 hours after consumption of assigned food and beverage
Decrease of lung function assessed by FVC
Measured: average 14 hours after consumption of assigned food and beverage
Decrease of lung function assessed by FEV1/FVC
Measured: average 14 hours after consumption of assigned food and beverage
Decrease of lung function assessed by FEF25-75
Measured: average 14 hours after consumption of assigned food and beverage
Increased exposure to Phthalate assessed by urinary concentration of metabolites
Measured: average 14 hours after consumption of assigned food and beverage
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Nov 2014 (estimated)
- Study startJan 2015
- Primary completionApr 2015 (estimated)
- Study completionApr 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (9)Papers the sponsor has linked to this study.
- Other trials for Insulin ResistanceStudies of the same condition, open and under way.
- More trials run by Seoul National University HospitalThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Seoul National University Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Yun-Chul Hong, MD, PhD, Principal investigator, College of Medicine, Seoul National Unveirsity
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02284477
- Sponsor's protocol ID
- 2014-2075
- Status last verified
- Oct 2014
- First submitted
- 30 Oct 2014
- Last updated
- 28 Jan 2015
- Results posted
- No
- Data monitoring committee
- Yes
Publications
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.
PubMed 17589594Rudel 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.
PubMed 21450549Singh S, Li SS. Epigenetic effects of environmental chemicals bisphenol A and phthalates. Int J Mol Sci. 2012;13(8):10143-10153. doi: 10.3390/ijms130810143. Epub 2012 Aug 15.
PubMed 22949852Manikkam 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.
PubMed 23359474Kim 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.
PubMed 25044062Kim 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.
PubMed 23977034Hoppin 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. doi: 10.1002/(sici)1097-0274(199811)34:53.0.co;2-u.
PubMed 9787851Zahm 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. doi: 10.1002/ajim.1117.
PubMed 11675618van 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. doi: 10.1158/1055-9965.EPI-05-0969.
PubMed 16896046
Study at a glance
From the registry record, last updated by the sponsor on 28 Jan 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Associations of Exposure to Phthalates With Insulin Resistance and Epigenetic Change
- ClinicalTrials.gov ID
- NCT02284477
- Acronym / sponsor ID
- 2014-2075
- Conditions
- Insulin Resistance, Decreased Pulmonary Function
- Keywords
- Insulin resistance, Pulmonary function, Phthalates
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Seoul National University HospitalUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Apr 2015 (estimated)
- Study completion
- Apr 2015 (estimated)
- First posted
- 6 Nov 2014 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
- 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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Triple blind (participant, care provider, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| non- PVC containing packing materials | Experimental | Other: non- PVC containing packing materialsParticipants 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. |
| PVC containing packing materials | Experimental | Other: PVC containing packing materialsParticipants 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. |
| Only lunch and dinner | No intervention | –Participant received food for lunch and dinner After 1 week, participant get over to each experimental arms. |
Who may qualify
- Ages
- 60 to 85 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Participants who understand aim of this study and who provided informed consent
Key exclusion criteria (2 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| non- PVC containing packing materialsAlso: Beverage stored in glass bottleBeverage which was stored in glass bottle for 24 hours in 4 ℃. | Other | non- PVC containing packing materials |
| PVC containing packing materialsAlso: Beverage stored in blood bagBeverage which was stored in PVC blood bag for 24 hours in 4 ℃. | Other | PVC containing packing materials |
Primary outcome
Increase of insulin resistance assessed by HOMA (Homeostatic model assessment)
Time frame: average 14 hours after consumption of assigned food and beverage
6 secondary outcomes
Change of DNA methylation assessed by Percent DNA methylation
Time frame: average 14 hours after consumption of assigned food and beverage
Decrease of lung function assessed by FEV1
Time frame: average 14 hours after consumption of assigned food and beverage
Decrease of lung function assessed by FVC
Time frame: average 14 hours after consumption of assigned food and beverage
Decrease of lung function assessed by FEV1/FVC
Time frame: average 14 hours after consumption of assigned food and beverage
Decrease of lung function assessed by FEF25-75
Time frame: average 14 hours after consumption of assigned food and beverage
Increased exposure to Phthalate assessed by urinary concentration of metabolites
Time frame: average 14 hours after consumption of assigned food and beverage
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Jan 2015.
- Background: PubMed 17589594Stahlhut 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.
- Background: PubMed 21450549Rudel 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.
- Background: PubMed 22949852Singh S, Li SS. Epigenetic effects of environmental chemicals bisphenol A and phthalates. Int J Mol Sci. 2012;13(8):10143-10153. doi: 10.3390/ijms130810143. Epub 2012 Aug 15.
- Background: PubMed 23359474Manikkam 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.
- Background: PubMed 25044062Kim 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.
- Background: PubMed 23977034Kim 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.
- Background: PubMed 9787851Hoppin 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. doi: 10.1002/(sici)1097-0274(199811)34:53.0.co;2-u.
- Background: PubMed 11675618Zahm 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. doi: 10.1002/ajim.1117.
- Background: PubMed 16896046van 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. doi: 10.1158/1055-9965.EPI-05-0969.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Yun-Chul Hong, MD, PhD principal investigator
College of Medicine, Seoul National Unveirsity
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing non- PVC containing packing materials and PVC containing packing materials in people with Insulin Resistance and Decreased Pulmonary Function, run by Seoul National University Hospital at 1 site in South Korea.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 1 inclusion and 2 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 28 Jan 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in South Korea. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Sanghyuk Bae, MD, PhD (+8227408576, sanghyukbae@snu.ac.kr), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Increase of insulin resistance assessed by HOMA (Homeostatic model assessment) (time frame: average 14 hours after consumption of assigned food and beverage). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT02284477, which also lists 9 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 28 Jan 2015.