- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01778868
Environmental Chemicals and Their Role in Obesity (ENDORUP)
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.
Study Overview
Status
Conditions
Study Type
Enrollment (Actual)
Contacts and Locations
Study Locations
-
-
Antwerpen
-
Edegem, Antwerpen, Belgium, 2650
- University Hospital Antwerp
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Sampling Method
Study Population
Description
Inclusion Criteria:
- adult
- Overweight (BMI > 25 kg/m²) or obesity (BMI > 30 kg/²)
Exclusion Criteria:
- Type 1 diabetes mellitus
- psychiatric illness
Study Plan
How is the study designed?
Design Details
Cohorts and Interventions
Group / Cohort |
---|
Overweight and obese individuals
|
Normal weight individuals
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
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 |
at the moment of entering a weight loss program
|
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
|
at the moment of entering a weight loss program
|
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 |
at the moment of entering a weight loss program
|
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
|
at the moment of entering a weight loss program
|
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
|
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
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 |
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
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
|
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
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 |
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
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
|
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
Time Frame: after 3,6 and 12 months of weight loss
|
The pollutants detected in urine comprise of bisphenol A, triclosan, phtalates
|
after 3,6 and 12 months of weight loss
|
Collaborators and Investigators
Sponsor
Collaborators
Investigators
- Principal Investigator: Philippe Jorens, MD, PhD, University Hospital, Antwerp
Publications and helpful links
General 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.
- Dirinck 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.
- Dirinck 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- ENDORUP
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