Clinical trial NCT01778868: Environmental Chemicals and Their Role in Obesity
Official title: Endocrine Disrupting Environmental Chemicals: From Accumulation to Their Role in the Global "Neuro-endocrine" Epidemic of Obesity and Its Metabolic Consequences
Study type: OBSERVATIONAL
Overall status: UNKNOWN
Conditions: Obesity
Lead sponsor: University Hospital, Antwerp
Sponsor class: OTHER
Collaborators: name: Universiteit Antwerpen
First posted: 2013-01-29
Enrollment: 203
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Observational model: COHORT
Time perspective: CROSS_SECTIONAL
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Individuals with BMI \> 25kg/m² and a normal weight (BMI \< 25 kg/m²) control population

Brief 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. 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.


Eligibility criteria: Inclusion Criteria:

* adult
* Overweight (BMI \> 25 kg/m²) or obesity (BMI \> 30 kg/²)

Exclusion Criteria:

* Type 1 diabetes mellitus
* psychiatric illness

Primary outcomes:
measure: Serum levels of polychlorinated biphenyls
timeFrame: at the moment of entering a weight loss program
measure: Serum levels of hydroxylated metabolites of polychlorinated biphenyls
timeFrame: at the moment of entering a weight loss program
measure: serum levels of organochlorine pesticides
timeFrame: at the moment of entering a weight loss program
measure: serum levels of polybrominated diphenyl ethers
timeFrame: at the moment of entering a weight loss program
measure: Urinary levels of pollutants
timeFrame: at the moment of entering a weight loss program
measure: Change in serum levels of polychlorinated biphenyls compared to the levels at the start of the weight loss program
timeFrame: after 3, 6 and 12 months of weight loss
measure: change in serum levels of hydroxylated metabolites of polychlorinated biphenyls compared to the level at the start of the weight loss program
timeFrame: after 3,6 and 12 months of weigth loss
measure: Change in serum levels of organochlorine pesticides compared to the level at the start of the weight loss program
timeFrame: after 3,6 and 12 months of weight loss
measure: Change in serum levels of polybrominated diphenyl ethers compared to the level at the start of the weight loss program
timeFrame: After 3,6 and 12 months of weight loss
measure: change in urine levels of pollutants compared to the level at the start of the weight loss program
timeFrame: after 3,6 and 12 months of weight loss
Secondary outcomes:
Other outcomes:
Locations:
city: Edegem
country: Belgium
facility: University Hospital Antwerp
state: Antwerpen
Study officials:
affiliation: University Hospital, Antwerp
name: Philippe Jorens, MD, PhD
role: PRINCIPAL_INVESTIGATOR
References:
citation: 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.
citation: 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.
citation: 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.