Obesity Clinical Trial
Official title:
Environmental Chemicals That Accumulate in Fat
Verified date | July 2019 |
Source | Hull and East Yorkshire Hospitals NHS Trust |
Contact | n/a |
Is FDA regulated | No |
Health authority | |
Study type | Interventional |
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.
Status | Completed |
Enrollment | 80 |
Est. completion date | January 30, 2016 |
Est. primary completion date | December 30, 2015 |
Accepts healthy volunteers | No |
Gender | All |
Age group | N/A and older |
Eligibility |
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 |
Country | Name | City | State |
---|---|---|---|
United Kingdom | Hull and east Yorkshire Hospitals NHS Trust | Hull |
Lead Sponsor | Collaborator |
---|---|
Hull and East Yorkshire Hospitals NHS Trust | University of Hull |
United Kingdom,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | Concentration of the dioxin and related compounds (endocrine disrupting chemicals) in adipose tissue and liver samples of obese population compared to non-obese population | to investigate the distribution of endocrine disrupting chemicals in obese and control population | 2 years | |
Secondary | Endocrine disrupting chemical concentrations in adipose tissue and liver samples after bariatric surgery | endocrine disrupting chemical concentrations will be measured before and after bariatric surgery | 2 years |
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