The Genetics of Adipose Tissue Function and Its Link to Type 2 Diabetes and Heart Disease (FATFUNgenes)
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|ClinicalTrials.gov Identifier: NCT04040595|
Recruitment Status : Recruiting
First Posted : July 31, 2019
Last Update Posted : July 31, 2019
Obesity is a major risk factor for Type 2 diabetes. However, two obese people of the same height and weight can have very different risks of the condition. As a greater proportion of the population is becoming obese, scientists need to understand more about why some people develop Type 2 diabetes at lower weight and why some people stay healthy despite being obese. The investigators and others provided evidence for genetic factors associated with higher weight for a given height but lower risk of diabetes, lower cholesterol and fat levels, lower blood pressure and lower risk of heart disease. The investigators showed that people who carry these genetic factors are able to store extra fat in a safe place, which is under the skin, as they gain weight. The proposed project aims to establish whether or not these genetic factors are associated with better development and function of fat tissue in storing extra fat. It is thought that a healthy and functional fat tissue in the human body has a key role in modifying the risk of diseases such as Type 2 diabetes, heart disease and hypertension.
Volunteers from Exeter 10,000 who gave their permission to contact them about further research will be recruited to the study. In those that agree, detailed body size measures, including body composition assessments by the BodPodTM machine will be recorded, a blood sample will be collected, and a small subcutaneous abdominal fat biopsy will be collected to measure fat cell size and from which a sample will be stored for future analyses. The results between people with and without the particular genetic changes of interest will be compared.
Knowing more about these genetic changes and how fat cells work could help to improve understanding of the factors that predispose, delay or protect obese individuals from Type 2 diabetes and other metabolic disturbances.
|Condition or disease||Intervention/treatment||Phase|
|Diabetes Mellitus||Procedure: Abdominal fat biopsy||Not Applicable|
Show Detailed Description
|Study Type :||Interventional (Clinical Trial)|
|Estimated Enrollment :||500 participants|
|Intervention Model:||Single Group Assignment|
|Intervention Model Description:||
• including current medications and lifestyle information (smoking/alcohol).
• Up to 20 ml venous blood sample for HbA1c and storage for analysis of biomarkers of adiposity.
Abdominal fat biopsy: for adipocyte measurements and store a sample for future analyses.
A sample of abdominal fat will be obtained by firstly injecting some local anaesthetic into an accessible area of the abdomen. Using a scalpel, a small incision (approx 2-3 cm) will be made to a depth of approx15mm and two small pea-sized samples of fat will be removed. The wound will be closed with simple sutures or steristrips.
|Masking:||None (Open Label)|
|Primary Purpose:||Basic Science|
|Official Title:||The Genetics of Adipose Tissue Function and Its Link to Type 2 Diabetes and Heart Disease|
|Actual Study Start Date :||March 7, 2019|
|Estimated Primary Completion Date :||February 28, 2021|
|Estimated Study Completion Date :||August 31, 2021|
Experimental: Adipocyte measurement
Abdominal fat biopsy
Procedure: Abdominal fat biopsy
A sample of abdominal fat will be obtained by firstly injecting some local anaesthetic into an accessible area of the abdomen. Using a scalpel, a small incision (approx 2-3 cm) will be made to a depth of approx 15mm and two small pea-sized samples of fat will be removed. The wound will be closed with simple sutures or steristrips.
- Mean adipocyte size (µm2) assessed using Image J software. [ Time Frame: Within 12 months of recruitment date of final participant ]ImageJ is a cross-platform image analysis tool developed to measure particle/cell size and will be used here to measure adipocyte size to test whether or not individuals carrying a high genetic load of "favourable adiposity" alleles have smaller subcutaneous fat cells.
- Adipose tissue expression of genes that are markers of adipogenesis (PPARy, CREBP). [ Time Frame: Within 12 months of recruitment date of final participant ]This secondary outcome is the adipocytes' gene expression measures of adipogenesis.
- Adipose tissue expression of genes that are markers of fibrosis (SPARC, collagens, TGFbeta, LOX). [ Time Frame: Within 12 months of recruitment date of final participant ]This secondary outcome is the adipocytes' gene expression measures of fibrosis.
- Adipose tissue expression of genes that are determinants of adipose inflammation (IL-1beta, IL-6, and 8, TNFalpha, MCP-1/CCL2). [ Time Frame: Within 12 months of recruitment date of final participant ]This secondary outcome is the adipocytes' gene expression measures of adipose inflammation.
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): NCT04040595
|Contact: Michelle Hudson, BSc||+44(0)1392 email@example.com|
|Contact: Hanieh Yaghootkar, PhD||H.Yaghootkar@exeter.ac.uk|
|Royal Devon and Exeter NHS Foundation Trust / University of Exeter||Recruiting|
|Exeter, Devon, United Kingdom, EX2 5DW|
|Contact: Michelle Hudson +44 (0)1392 408183 firstname.lastname@example.org|
|Contact: Andrew Pitt +44 (0)1392 408190 email@example.com|
|Principal Investigator: Timothy M Frayling (Professor), PhD|
|Sub-Investigator: Hanieh Yaghootkar, PhD|
|Sub-Investigator: Katarina Kos, PhD|
|Principal Investigator:||Timothy Frayling, PhD||University of Exeter|