CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 304 enrolled
Drug / intervention
Oral Triglyceride Tolerance Test (OTTT) +1 moreother
Likely dose
Not stated in record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.

Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.

Search/NCT02505321
NCT02505321N/ACompleted

Defining Adipose Tissue Lipid Deposition in Normal Weight Individuals With a Genetic Predisposition to Insulin Resistance

Royal Devon and Exeter NHS Foundation Trust·interventional·Posted Jul 22, 2015·Updated Jun 21, 2018

In Brief

A clinical study evaluating Oral Triglyceride Tolerance Test (OTTT) and Abdominal fat biopsy (optional) for Diabetes Mellitus. Completed, enrolled 304 participants across 1 site.

Detailed 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.

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited Kingdom

Timeline

N/ACompletedFinished
20162017201820192020202120222023202420252026
First PostedJul 22, 2015
Enrollment StartMay 29, 2015
Primary CompletionOct 31, 2017
TodayJul 2, 2026
Enrollment to primary: 2.4 yearsPosted 10.9 years ago

Interventions

Oral Triglyceride Tolerance Test (OTTT)other

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.

Abdominal fat biopsy (optional)procedure

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.