Environmental Chemicals and Their Role in Obesity (ENDORUP)

January 28, 2013 updated by: Ethisch Comité UZ Antwerpen, University Hospital, Antwerp

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

Unknown

Conditions

Study Type

Observational

Enrollment (Actual)

203

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

    • Antwerpen
      • Edegem, Antwerpen, Belgium, 2650
        • University Hospital Antwerp

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Sampling Method

Non-Probability Sample

Study Population

Individuals with BMI > 25kg/m² and a normal weight (BMI < 25 kg/m²) control 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

This section provides details of the study plan, including how the study is designed and what the study is measuring.

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

This is where you will find people and organizations involved with this study.

Collaborators

Investigators

  • Principal Investigator: Philippe Jorens, MD, PhD, University Hospital, Antwerp

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2009

Primary Completion (Anticipated)

March 1, 2013

Study Completion (Anticipated)

July 1, 2013

Study Registration Dates

First Submitted

January 18, 2013

First Submitted That Met QC Criteria

January 28, 2013

First Posted (Estimate)

January 29, 2013

Study Record Updates

Last Update Posted (Estimate)

January 29, 2013

Last Update Submitted That Met QC Criteria

January 28, 2013

Last Verified

January 1, 2013

More Information

Terms related to this study

Other Study ID Numbers

  • ENDORUP

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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