Environmental Chemicals and Their Role in Obesity

Obesity Clinical Trial

— ENDORUP  

Official title:

Endocrine Disrupting Environmental Chemicals: From Accumulation to Their Role in the Global "Neuro-endocrine" Epidemic of Obesity and Its Metabolic Consequences

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01778868
• Other study ID #: ENDORUP
• Status: Active, not recruiting
• Phase: N/A
• First received: January 18, 2013
• Last updated: January 28, 2013
• Start date: August 2009
• Est. completion date: July 2013

Study information

• Verified date: January 2013
• Source: University Hospital, Antwerp
• Contact: n/a
• Is FDA regulated: No
• Health authority: Belgium: Ethics Committee
• Study type: Observational

Clinical 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. 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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 203
• Est. completion date: July 2013
• Est. primary completion date: March 2013
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• adult

• Overweight (BMI > 25 kg/m²) or obesity (BMI > 30 kg/²)

Exclusion Criteria:

• Type 1 diabetes mellitus

• psychiatric illness

Study Design

Observational Model: Cohort, Time Perspective: Cross-Sectional

Related Conditions & MeSH terms

• Obesity

Locations

Country	Name	City	State
Belgium	University Hospital Antwerp	Edegem	Antwerpen

Sponsors (2)

Lead Sponsor	Collaborator
University Hospital, Antwerp	Universiteit Antwerpen

Country where clinical trial is conducted

Belgium, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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	at the moment of entering a weight loss program	No
Primary	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	at the moment of entering a weight loss program	No
Primary	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	at the moment of entering a weight loss program	No
Primary	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	at the moment of entering a weight loss program	No
Primary	Urinary levels of pollutants	The pollutants detected in urine comprise of bisphenol A, triclosan, phtalates	at the moment of entering a weight loss program	No
Primary	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	after 3, 6 and 12 months of weight loss	No
Primary	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	after 3,6 and 12 months of weigth loss	No
Primary	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	after 3,6 and 12 months of weight loss	No
Primary	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	After 3,6 and 12 months of weight loss	No
Primary	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	after 3,6 and 12 months of weight loss	No