for Adipose Tissue DIabetes VAriants (fATDIVA)

NCT02505321 · Status: COMPLETED · Phase: NA · Type: INTERVENTIONAL · Enrollment: 304

Last updated 2018-06-21

No results posted yet for this study

Summary

The adipose (fat) cells under the skin are where individuals store excess fat. The more excess fat they have, the more "strain" they put on these cells which then get bigger and don't work as well as they should. Having some fat under the skin is important. People who have a genetic defect which results in them having almost no fat under their skin have a very high risk of a condition called insulin resistance (where the body does not respond as well to insulin and blood sugar levels rise). This can lead to diabetes and heart disease despite them not being overweight.

Scientists have only recently started to understand the importance of fat in insulin resistance and how people unable to store fat very well can have insulin resistance despite not being obese. The investigators have also recently discovered that small changes in a person's genetic code (their body's instruction manual) may also affect their ability to store fat and would like to explore this in more detail. To do this, they will recruit volunteers from the Exeter 10,000 study who gave permission to contact them about further research. The investigators will collect detailed body size measures and blood samples taken before and after a special drink that is high in fat (similar to a thick milk shake), then compare the results between people with and without the particular genetic changes of interest.

Knowing more about these genetic changes and how fat cells work could help to improve understanding about why some people develop diabetes and heart disease despite a relatively normal BMI.

Conditions

Interventions

OTHER

Oral Triglyceride Tolerance Test (OTTT)

Participants consume a fatty drink. An intravenous catheter is inserted into the antecubital veins in one arm for intermittent sampling over the following 4 hours. The OTTT permits simple evaluation of postchallenge triglyceride levels and is acceptable to participants.

PROCEDURE

Abdominal fat biopsy (optional)

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.

Sponsors & Collaborators

  • University of Exeter

    collaborator OTHER
  • Royal Devon and Exeter NHS Foundation Trust

    lead OTHER

Principal Investigators

  • Timothy M Frayling (Prof), PhD · University of Exeter

Study Design

Allocation
NON_RANDOMIZED
Purpose
BASIC_SCIENCE
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
75 Years
Sex
ALL
Healthy Volunteers
Yes

Timeline & Regulatory

Start
2015-05-29
Primary Completion
2017-10-31
Completion
2017-10-31

Countries

  • United Kingdom

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02505321 on ClinicalTrials.gov