CI

At a glance

ClinicalIndex Comparison Record
N/ACompleted· 207 enrolled
Drug / intervention
Abdominal fat biopsyprocedure
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/NCT04040595
NCT04040595N/ACompleted

The Genetics of Adipose Tissue Function and Its Link to Type 2 Diabetes and Heart Disease

Royal Devon and Exeter NHS Foundation Trust·interventional·Posted Jul 31, 2019·Updated Jun 8, 2021

In Brief

A clinical study evaluating Abdominal fat biopsy for Diabetes Mellitus. Completed, enrolled 207 participants across 1 site.

Detailed Summary

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.

Study Details

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

Timeline

N/ACompletedFinished
20192020202120222023202420252026
First PostedJul 31, 2019
Enrollment StartMar 7, 2019
Primary CompletionMay 20, 2021
TodayJul 2, 2026
Enrollment to primary: 2.2 yearsPosted 6.9 years ago

Interventions

Abdominal fat biopsyprocedure

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.