ObesityENDORUPNCT01778868
Environmental Chemicals and Their Role in Obesity
An observational study of Obesity, run by University Hospital, Antwerp at 1 site in Belgium.
Trial summary
Hormonal disruption is the inappropriate alteration of the hormonal system by chemical substances that are present in our environment. Some chemical substances are capable of replicating, enhancing or reducing the production, release, transport or action of natural hormones. Read more about this study
- Who is it for?
- Ages 18 years and olderHealthy volunteers can take part
- Conditions the study is for
- Obesity
- How many people
- 203 participants
- Where
- 1 siteBelgium
- Study dates
- Aug 2009to Jul 2013
- Phase
- Observational
- 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 18 years and older
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: Individuals with BMI > 25kg/m² and a normal weight (BMI < 25 kg/m²) control population
Who may be able to join
- adult
- Overweight (BMI > 25 kg/m²) or obesity (BMI > 30 kg/²)
Who cannot join
- Type 1 diabetes mellitus
- psychiatric illness
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Endocrine Disrupting Environmental Chemicals: From Accumulation to Their Role in the Global "Neuro-endocrine" Epidemic of Obesity and Its Metabolic Consequences
Hormonal disruption is the inappropriate alteration of the hormonal system by chemical substances that are present in our environment. Some chemical substances are capable of replicating, enhancing or reducing the production, release, transport or action of natural hormones. Therefore, they are called hormonal or endocrine disrupters. Some 'classic' endocrine disrupters such as pesticides and dioxins are considered responsible for infertility, cancer and thyroid problems. Recently, a number of additional chemical substances were stipulated to have endocrine disrupting capabilities. The industrial production of these substances in large quantities has led to an accumulation in our environment and thus possible negative consequences on human health.
The aim of this study is to investigate the rol of these chemical substances in the occurence of overweight and obesity.
- Conditions
- Obesity
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| Overweight and obese individuals | Not described | |
| Normal weight individuals | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
Serum levels of polychlorinated biphenyls
The following PCB congeners are measured (official IUPAC number is given):
CB 28 CB 52 CB 74 CB 95 CB 99 CB 101 CB 105 CB 118 CB 149 CB 146 CB 153 CB 138 CB 187 CB 183 CB 128 CB 167 CB 174 CB 177 CB 171 CB 172 CB 156 CB 180 CB 170 CB 199 CB 196/203 CB 194 CB 206 CB 209
Measured: at the moment of entering a weight loss program
Serum levels of hydroxylated metabolites of polychlorinated biphenyls
The following hydroxylated metabolites of polychlorinated biphenyls are measured 4-HO-CB79 4-HO-CB120 3HO-CB118 4HO-CB107 3HO-CB153 4HO-CB146 4HO-CB127 3HO-CB138 4HO-CB130 4HO-CB163 4HO-CB187 4-HO-CB162 4-HO-CB177 3HO-CB180 4HO-CB172 4HO-CB193 4-diMeO-CB202 4-HO-CB208
Measured: at the moment of entering a weight loss program
serum levels of organochlorine pesticides
The following organochlorine pesticides are measured:
alfa- hexachlorocyclohexane, beta-hexachlorocyclohexane, gamma-hexachlorocyclohexane Hexachlorobenzen Ocychlordane Transnonachlor p-p-dichlorodiphenyltrichloroethane, p,p'-dichlorodiphenyldichloroethylene pp-dichlorodiphenyldichloroethane
Measured: at the moment of entering a weight loss program
serum levels of polybrominated diphenyl ethers
The following polybrominated diphenyl ethers (BDE) are measured: BDE 28 BDE 47 BDE 100 BDE 99 BDE 154 BDE 153 BDE 183
Measured: at the moment of entering a weight loss program
Urinary levels of pollutants
The pollutants detected in urine comprise of bisphenol A, triclosan, phtalates
Measured: at the moment of entering a weight loss program
Change in serum levels of polychlorinated biphenyls compared to the levels at the start of the weight loss program
The following PCB congeners are measured (official IUPAC number is given):
CB 28 CB 52 CB 74 CB 95 CB 99 CB 101 CB 105 CB 118 CB 149 CB 146 CB 153 CB 138 CB 187 CB 183 CB 128 CB 167 CB 174 CB 177 CB 171 CB 172 CB 156 CB 180 CB 170 CB 199 CB 196/203 CB 194 CB 206 CB 209
Measured: after 3, 6 and 12 months of weight loss
change in serum levels of hydroxylated metabolites of polychlorinated biphenyls compared to the level at the start of the weight loss program
The following hydroxylated metabolites of polychlorinated biphenyls are measured 4-HO-CB79 4-HO-CB120 3HO-CB118 4HO-CB107 3HO-CB153 4HO-CB146 4HO-CB127 3HO-CB138 4HO-CB130 4HO-CB163 4HO-CB187 4-HO-CB162 4-HO-CB177 3HO-CB180 4HO-CB172 4HO-CB193 4-diMeO-CB202 4-HO-CB208
Measured: after 3,6 and 12 months of weigth loss
Change in serum levels of organochlorine pesticides compared to the level at the start of the weight loss program
The following organochlorine pesticides are measured:
alfa- hexachlorocyclohexane, beta-hexachlorocyclohexane, gamma-hexachlorocyclohexane Hexachlorobenzen Ocychlordane Transnonachlor p-p-dichlorodiphenyltrichloroethane, p,p'-dichlorodiphenyldichloroethylene pp-dichlorodiphenyldichloroethane
Measured: after 3,6 and 12 months of weight loss
Change in serum levels of polybrominated diphenyl ethers compared to the level at the start of the weight loss program
The following polybrominated diphenyl ethers (BDE) are measured: BDE 28 BDE 47 BDE 100 BDE 99 BDE 154 BDE 153 BDE 183
Measured: After 3,6 and 12 months of weight loss
change in urine levels of pollutants compared to the level at the start of the weight loss program
The pollutants detected in urine comprise of bisphenol A, triclosan, phtalates
Measured: after 3,6 and 12 months of weight loss
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Jan 2013 (estimated)
- Study startAug 2009
- Primary completionMar 2013 (estimated)
- Study completionJul 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (3)Papers the sponsor has linked to this study.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by University Hospital, AntwerpThe 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
- Observational
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Enrolment
- 203 participants (actual)
Sponsor and investigators
- Lead sponsor
- University Hospital, Antwerp
- Sponsor type
- University, hospital or other
- Collaborators
- Universiteit Antwerpen
- Responsible party
- Principal investigator, Ethisch Comité UZ Antwerpen, University Hospital, Antwerp
- Investigators
- Philippe Jorens, MD, PhD, Principal investigator, University Hospital, Antwerp
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01778868
- Sponsor's protocol ID
- ENDORUP
- Acronym
- ENDORUP
- Status last verified
- Jan 2013
- First submitted
- 18 Jan 2013
- Last updated
- 29 Jan 2013
- Results posted
- No
- Data monitoring committee
- No
Publications
Dirinck EL, Dirtu AC, Govindan M, Covaci A, Jorens PG, Van Gaal LF. Endocrine-disrupting polychlorinated biphenyls in metabolically healthy and unhealthy obese subjects before and after weight loss: difference at the start but not at the finish. Am J Clin Nutr. 2016 Apr;103(4):989-98. doi: 10.3945/ajcn.115.119081.
PubMed 26961932Dirinck E, Dirtu AC, Jorens PG, Malarvannan G, Covaci A, Van Gaal LF. Pivotal Role for the Visceral Fat Compartment in the Release of Persistent Organic Pollutants During Weight Loss. J Clin Endocrinol Metab. 2015 Dec;100(12):4463-71. doi: 10.1210/jc.2015-2571. Epub 2015 Oct 15.
PubMed 26469381Dirinck EL, Dirtu AC, Govindan M, Covaci A, Van Gaal LF, Jorens PG. Exposure to persistent organic pollutants: relationship with abnormal glucose metabolism and visceral adiposity. Diabetes Care. 2014 Jul;37(7):1951-8. doi: 10.2337/dc13-2329.
PubMed 24963112
Study at a glance
From the registry record, last updated by the sponsor on 29 Jan 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Endocrine Disrupting Environmental Chemicals: From Accumulation to Their Role in the Global "Neuro-endocrine" Epidemic of Obesity and Its Metabolic Consequences
- ClinicalTrials.gov ID
- NCT01778868
- Acronym / sponsor ID
- ENDORUP / ENDORUP
- Conditions
- Obesity
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 203 participants (actual)
- Lead sponsor
- University Hospital, AntwerpUniversity, hospital or other
- Collaborators
- Universiteit Antwerpen
- Study start
- Aug 2009
- Primary completion
- Mar 2013 (estimated)
- Study completion
- Jul 2013 (estimated)
- First posted
- 29 Jan 2013 (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.
Hormonal disruption is the inappropriate alteration of the hormonal system by chemical substances that are present in our environment. Some chemical substances are capable of replicating, enhancing or reducing the production, release, transport or action of natural hormones. Therefore, they are called hormonal or endocrine disrupters. Some 'classic' endocrine disrupters such as pesticides and dioxins are considered responsible for infertility, cancer and thyroid problems. Recently, a number of additional chemical substances were stipulated to have endocrine disrupting capabilities. The industrial production of these substances in large quantities has led to an accumulation in our environment and thus possible negative consequences on human health.
The aim of this study is to investigate the rol of these chemical substances in the occurence of overweight and obesity.
Study design
- Observational model
- Cohort
- Time perspective
- Cross-sectional
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Overweight and obese individuals | – | – |
| Normal weight individuals | – | – |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- Individuals with BMI > 25kg/m² and a normal weight (BMI < 25 kg/m²) control population
Key inclusion criteria (2 listed)
- adult
- Overweight (BMI > 25 kg/m²) or obesity (BMI > 30 kg/²)
Key exclusion criteria (2 listed)
- Type 1 diabetes mellitus
- psychiatric illness
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
Serum levels of polychlorinated biphenyls
Time frame: at the moment of entering a weight loss program
The following PCB congeners are measured (official IUPAC number is given): CB 28 CB 52 CB 74 CB 95 CB 99 CB 101 CB 105 CB 118 CB 149 CB 146 CB 153 CB 138 CB 187 CB 183 CB 128 CB 167 CB 174 CB 177 CB 171 CB 172 CB 156 CB 180 CB 170 CB 199 CB 196/203 CB 194 CB 206 CB 209
Serum levels of hydroxylated metabolites of polychlorinated biphenyls
Time frame: at the moment of entering a weight loss program
The following hydroxylated metabolites of polychlorinated biphenyls are measured 4-HO-CB79 4-HO-CB120 3HO-CB118 4HO-CB107 3HO-CB153 4HO-CB146 4HO-CB127 3HO-CB138 4HO-CB130 4HO-CB163 4HO-CB187 4-HO-CB162 4-HO-CB177 3HO-CB180 4HO-CB172 4HO-CB193 4-diMeO-CB202 4-HO-CB208
serum levels of organochlorine pesticides
Time frame: at the moment of entering a weight loss program
The following organochlorine pesticides are measured: alfa- hexachlorocyclohexane, beta-hexachlorocyclohexane, gamma-hexachlorocyclohexane Hexachlorobenzen Ocychlordane Transnonachlor p-p-dichlorodiphenyltrichloroethane, p,p'-dichlorodiphenyldichloroethylene pp-dichlorodiphenyldichloroethane
serum levels of polybrominated diphenyl ethers
Time frame: at the moment of entering a weight loss program
The following polybrominated diphenyl ethers (BDE) are measured: BDE 28 BDE 47 BDE 100 BDE 99 BDE 154 BDE 153 BDE 183
Urinary levels of pollutants
Time frame: at the moment of entering a weight loss program
The pollutants detected in urine comprise of bisphenol A, triclosan, phtalates
Change in serum levels of polychlorinated biphenyls compared to the levels at the start of the weight loss program
Time frame: after 3, 6 and 12 months of weight loss
The following PCB congeners are measured (official IUPAC number is given): CB 28 CB 52 CB 74 CB 95 CB 99 CB 101 CB 105 CB 118 CB 149 CB 146 CB 153 CB 138 CB 187 CB 183 CB 128 CB 167 CB 174 CB 177 CB 171 CB 172 CB 156 CB 180 CB 170 CB 199 CB 196/203 CB 194 CB 206 CB 209
change in serum levels of hydroxylated metabolites of polychlorinated biphenyls compared to the level at the start of the weight loss program
Time frame: after 3,6 and 12 months of weigth loss
The following hydroxylated metabolites of polychlorinated biphenyls are measured 4-HO-CB79 4-HO-CB120 3HO-CB118 4HO-CB107 3HO-CB153 4HO-CB146 4HO-CB127 3HO-CB138 4HO-CB130 4HO-CB163 4HO-CB187 4-HO-CB162 4-HO-CB177 3HO-CB180 4HO-CB172 4HO-CB193 4-diMeO-CB202 4-HO-CB208
Change in serum levels of organochlorine pesticides compared to the level at the start of the weight loss program
Time frame: after 3,6 and 12 months of weight loss
The following organochlorine pesticides are measured: alfa- hexachlorocyclohexane, beta-hexachlorocyclohexane, gamma-hexachlorocyclohexane Hexachlorobenzen Ocychlordane Transnonachlor p-p-dichlorodiphenyltrichloroethane, p,p'-dichlorodiphenyldichloroethylene pp-dichlorodiphenyldichloroethane
Change in serum levels of polybrominated diphenyl ethers compared to the level at the start of the weight loss program
Time frame: After 3,6 and 12 months of weight loss
The following polybrominated diphenyl ethers (BDE) are measured: BDE 28 BDE 47 BDE 100 BDE 99 BDE 154 BDE 153 BDE 183
change in urine levels of pollutants compared to the level at the start of the weight loss program
Time frame: after 3,6 and 12 months of weight loss
The pollutants detected in urine comprise of bisphenol A, triclosan, phtalates
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Jan 2013.
- Derived from this study: PubMed 26961932Dirinck EL, Dirtu AC, Govindan M, Covaci A, Jorens PG, Van Gaal LF. Endocrine-disrupting polychlorinated biphenyls in metabolically healthy and unhealthy obese subjects before and after weight loss: difference at the start but not at the finish. Am J Clin Nutr. 2016 Apr;103(4):989-98. doi: 10.3945/ajcn.115.119081.
- Derived from this study: PubMed 26469381Dirinck E, Dirtu AC, Jorens PG, Malarvannan G, Covaci A, Van Gaal LF. Pivotal Role for the Visceral Fat Compartment in the Release of Persistent Organic Pollutants During Weight Loss. J Clin Endocrinol Metab. 2015 Dec;100(12):4463-71. doi: 10.1210/jc.2015-2571. Epub 2015 Oct 15.
- Derived from this study: PubMed 24963112Dirinck EL, Dirtu AC, Govindan M, Covaci A, Van Gaal LF, Jorens PG. Exposure to persistent organic pollutants: relationship with abnormal glucose metabolism and visceral adiposity. Diabetes Care. 2014 Jul;37(7):1951-8. doi: 10.2337/dc13-2329.
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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.
Philippe Jorens, MD, PhD principal investigator
University Hospital, Antwerp
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Obesity, run by University Hospital, Antwerp at 1 site in Belgium.
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 2 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 29 Jan 2013. 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 Belgium. 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?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Serum levels of polychlorinated biphenyls (time frame: at the moment of entering a weight loss program). The study lists 10 primary outcomes in all. 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 NCT01778868, which also lists 3 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 29 Jan 2013.