Environmental Chemicals That Accumulate in Fat

NCT03726567 | Completed

• 1 other identifier: 10/H1304/13
• Study Type: interventional
• Target: 80
• Locations: 1 country
• Sites: 1

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

Conditions

Obesity

Outcome Measures

Primary Outcomes (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

  to investigate the distribution of endocrine disrupting chemicals in obese and control population

  2 years

Secondary Outcomes (1)

• Endocrine disrupting chemical concentrations in adipose tissue and liver samples after bariatric surgery

  2 years

Study Arms (2)

Bariatric surgery group

ACTIVE COMPARATOR

Patients who are undergoing bariatric surgery for weight loss

Procedure: Bariatric surgery

Non bariatric surgery group

NO INTERVENTION

Patients who are undergoing abdominal surgery for non-weight loss reasons

Interventions

Bariatric surgery PROCEDURE

Roux-en-Y surgery

Bariatric surgery group

Eligibility Criteria

• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• \* Participants unable to give informed consent

Sponsors & Collaborators

• Hull University Teaching Hospitals NHS Trust: lead
• University of Hull: collaborator

Study Sites (1)

Hull and east Yorkshire Hospitals NHS Trust

Hull, HU32RW, United Kingdom

Location

MeSH Terms

Conditions

Obesity

Interventions

Bariatric Surgery

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Bariatrics; Obesity Management; Therapeutics; Surgical Procedures, Operative

Study Officials

• Thozhukat Sathyapalan

  Hull University Teaching Hospitals NHS Trust

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER GOV
• Responsible Party: SPONSOR

Model Details: Participants who are undergoing bariatric surgery and control group who is having abdominal surgery for non-bariatric reasons

Study Record Dates

• First Submitted: July 22, 2017
• First Posted: October 31, 2018
• Study Start: October 12, 2012
• Primary Completion: December 30, 2015
• Study Completion: January 30, 2016
• Last Updated: July 15, 2019

Record last verified: 2019-07

Data Sharing

• IPD Sharing: Will not share

Locations

GB (1)