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
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.
- Investigation of the toxicodynamics of/dioxin distribution in adipose of a morbidly obese and comparative control population
- Characterisation of the burden of dioxins in liver and adipose tissue, and the relationship with blood levels of dioxins, in a UK population
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
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||80 participants|
|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)|
|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|
Active Comparator: Bariatric surgery group
Patients who are undergoing bariatric surgery for weight loss
Procedure: Bariatric surgery
No Intervention: Non bariatric surgery group
Patients who are undergoing abdominal surgery for non-weight loss reasons
- 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
- 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
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
|Hull and east Yorkshire Hospitals NHS Trust|
|Hull, United Kingdom, HU32RW|
|Principal Investigator:||Thozhukat Sathyapalan||Hull University Teaching Hospitals NHS Trust|