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Environmental Chemicals That Accumulate in Fat

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03726567
Recruitment Status : Completed
First Posted : October 31, 2018
Last Update Posted : July 15, 2019
Sponsor:
Collaborator:
University of Hull
Information provided by (Responsible Party):
Hull University Teaching Hospitals NHS Trust

Brief Summary:

A crucial factor in evaluating the risk of dioxins, and related endocrine disruptor compounds (dioxins for short) in the human population is the accumulation of these chemicals in the human body. Human data on tissue background levels is extremely limited, and there are no studies in UK populations, although there are several European studies looking at blood levels of dioxins. Adipose tissue concentrations were 139 ng of TEQ (total dioxin-like compounds) per kg lipid weight (5.4 ± 4.6 ng of TCDD per kg lipid weight). However, given the different dietary habits of Japanese populations, compared to European populations, these estimates may differ considerably from UK values. Thus determining human tissue concentrations of dioxins is an important issue for assessing the risk to public health from these compounds, and this information is currently lacking for European populations. This information will also guide and inform the necessity fro continued measures to reduce the environmental dioxin levels in the UK.

Aims

Primary outcomes:

  1. Investigation of the toxicodynamics of/dioxin distribution in adipose of a morbidly obese and comparative control population
  2. Characterisation of the burden of dioxins in liver and adipose tissue, and the relationship with blood levels of dioxins, in a UK population

Secondary outcome:

Determining whether bariatric surgery-induced weight loss causes an increase in tissue concentration of dioxin-like compounds

The primary aims of this study will yield useful information to refine the risk assessment process for the obese population.

Experimental Methodology This proposal seeks to examine thirty non-obese patients taking liver (500mg) and adipose tissue (visceral and subcutaneous: 40g each) samples at the time of gastric/abdominal surgery; and thirty obese patients, taking liver (500mg) and adipose tissue (visceral and subcutaneous: 40g each) samples at the time of undertaking Roux -en-y bariatric surgery. Weight and bioimpedance and a food diary will be performed prior to surgery.

A further body weight and bioimpedance will be undertaken at 3, 6, 9 and 12 months from the obese population. A subcutaneous adipose biopsy will be taken under local anaesthetic from these individuals at after bariatric surgery (minimum of 10% body weight loss). A record of weight loss since bariatric surgery will documented with the change in body composition. The statistical power for seeing an effect of gastroplasty, assuming a coefficient of variation of TEQ measurements of 75% and an increase in TEQ of two-fold, is 90% at P<0.05 for a population of thirty individuals.

Should subjects need additional surgery (eg. cholecystectomy, diagnostic laproscopy) either as a consequence of bariatric surgery or for any other reasons during the 24 month following initial operation, a liver biopsy and visceral fat biopsy will be taken during the future surgery. If subjects undergo abdominal wall surgeries (eg. Apronectomy, ventral hernia repair) in the 24 months following initial bariatric surgery, an subcutaneous fat biopsy will be taken during the future surgery.


Condition or disease Intervention/treatment Phase
Obesity Procedure: Bariatric surgery Not Applicable

  Show Detailed Description

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 80 participants
Allocation: Non-Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Participants who are undergoing bariatric surgery and control group who is having abdominal surgery for non-bariatric reasons
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Environmental Chemicals That Accumulate in Fat
Actual Study Start Date : October 12, 2012
Actual Primary Completion Date : December 30, 2015
Actual Study Completion Date : January 30, 2016

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Active Comparator: Bariatric surgery group
Patients who are undergoing bariatric surgery for weight loss
Procedure: Bariatric surgery
Roux-en-Y surgery

No Intervention: Non bariatric surgery group
Patients who are undergoing abdominal surgery for non-weight loss reasons



Primary Outcome Measures :
  1. Concentration of the dioxin and related compounds (endocrine disrupting chemicals) in adipose tissue and liver samples of obese population compared to non-obese population [ Time Frame: 2 years ]
    to investigate the distribution of endocrine disrupting chemicals in obese and control population


Secondary Outcome Measures :
  1. Endocrine disrupting chemical concentrations in adipose tissue and liver samples after bariatric surgery [ Time Frame: 2 years ]
    endocrine disrupting chemical concentrations will be measured before and after bariatric surgery



Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Body mass index of more than 25
  • Listed for bariatric surgery
  • Control group - participants who are listed for abdominal surgery for non-weight loss reason

Exclusion Criteria:

* Participants unable to give informed consent


Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03726567


Locations
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United Kingdom
Hull and east Yorkshire Hospitals NHS Trust
Hull, United Kingdom, HU32RW
Sponsors and Collaborators
Hull University Teaching Hospitals NHS Trust
University of Hull
Investigators
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Principal Investigator: Thozhukat Sathyapalan Hull University Teaching Hospitals NHS Trust

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Responsible Party: Hull University Teaching Hospitals NHS Trust
ClinicalTrials.gov Identifier: NCT03726567     History of Changes
Other Study ID Numbers: 10/H1304/13
First Posted: October 31, 2018    Key Record Dates
Last Update Posted: July 15, 2019
Last Verified: July 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No
Plan Description: Will be published in Food Standards Agency website

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Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No