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Environmental Chemicals and Their Role in Obesity (ENDORUP)

This study is ongoing, but not recruiting participants.
Sponsor:
Collaborator:
Universiteit Antwerpen
Information provided by (Responsible Party):
Ethisch Comité UZ Antwerpen, University Hospital, Antwerp
ClinicalTrials.gov Identifier:
NCT01778868
First received: January 18, 2013
Last updated: January 28, 2013
Last verified: January 2013
History of Changes
  Purpose

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.


Condition
Obesity

Study Type: Observational
Study Design: Observational Model: Cohort
Time Perspective: Cross-Sectional
Official Title: Endocrine Disrupting Environmental Chemicals: From Accumulation to Their Role in the Global "Neuro-endocrine" Epidemic of Obesity and Its Metabolic Consequences

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by University Hospital, Antwerp:

Primary Outcome Measures:
  • Serum levels of polychlorinated biphenyls [ Time Frame: at the moment of entering a weight loss program ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]

    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 ] [ Designated as safety issue: No ]
    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 ] [ Designated as safety issue: No ]
    The pollutants detected in urine comprise of bisphenol A, triclosan, phtalates


Biospecimen Retention:   Samples With DNA

Blood samples Urinary samples Fat samples


Enrollment: 203
Study Start Date: August 2009
Estimated Study Completion Date: July 2013
Estimated Primary Completion Date: March 2013 (Final data collection date for primary outcome measure)
Groups/Cohorts
Overweight and obese individuals
Normal weight individuals

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population

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

Criteria

Inclusion Criteria:

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

Exclusion Criteria:

  • Type 1 diabetes mellitus
  • psychiatric illness
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01778868

Locations
Belgium
University Hospital Antwerp
Edegem, Antwerpen, Belgium, 2650
Sponsors and Collaborators
University Hospital, Antwerp
Universiteit Antwerpen
Investigators
Principal Investigator: Philippe Jorens, MD, PhD University Hospital, Antwerp
  More Information

No publications provided

Responsible Party: Ethisch Comité UZ Antwerpen, University Hospital, Antwerp
ClinicalTrials.gov Identifier: NCT01778868     History of Changes
Other Study ID Numbers: ENDORUP
Study First Received: January 18, 2013
Last Updated: January 28, 2013
Health Authority: Belgium: Ethics Committee

Additional relevant MeSH terms:
Obesity
Overnutrition
Nutrition Disorders
 Overweight
Body Weight
Signs and Symptoms

ClinicalTrials.gov processed this record on May 16, 2013