1. To evaluate and optimize a protocol for quantifying brown adipose tissue with MRI and to assess BAT volume per patient. 2. To assess the reproducibility of MRI measurments by determining, inter-scan, intra-observer and inter-observer variability…
ID
Source
Brief title
Condition
- Other condition
Synonym
Health condition
Vetweefsel
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
Reproducibility of measuring BAT volume (mL) within the supraclavicular fossae
by determining inter-scan, inter-observer and intra-observer variability.
Addendum.
Adipose tissue estimated Fat Fraction. From this a volume estimation of brown
adipose tissue can be derived.
Secondary outcome
Not applicable.
Background summary
Brown Adipose Tissue (BAT) is responsible for non-shivering thermogenesis using
triglycerides and glucose as its substrate. Because BAT might be an attractive
target in diminishing or preventing obesity and obesity related cardiovascular
disease, reliable and reproducible quantification of BAT in patients at risk
for or having these diseases is highly desirable. MRI could address the need
for quantification of BAT. However, although few studies already have used this
new MRI technique in young adults without cardiovascular disease, it has never
been performed in older patients with cardiovascular disease and studies
regarding feasibility and reproducibility within this population are lacking.
Addendum.
Aforementioned MRI technique is currently feasible and displays high
reproducibility.
Study objective
1. To evaluate and optimize a protocol for quantifying brown adipose tissue
with MRI and to assess BAT volume per patient.
2. To assess the reproducibility of MRI measurments by determining, inter-scan,
intra-observer and inter-observer variability in BAT volume.
Addendum.
3. To quantify the relation between Fat Fraction measurements of
supraclavicular and subcutaneous adipose tissue depots and patient
characteristics (BMI and metabolic dysfunction) in an adult population of
patients with manifest vascular disease or at high risk for cardiovascular
events.
Study design
The design of this study is observational and cross-sectional.
At the scheduled appointment participants will come to the hospital to undergo
a MRI scan wich is expected to take around 1 hour in total.
BAT volume (mL) is estimated from differences in MRI Fat signal Fractions (FF)
values and differences in MRI T2*values between the bilateral supraclavicular
fossae (presumably BAT) and adjacent subcutaneous tissues (presumably WAT).
Study burden and risks
The SMART cohort comprises patients with cardiovascular disease. The effort
asked (MRI measurement of 1 hour) of participants is regarded as acceptable and
in proportion to the incentives. Patients do not have to be in a fasting state.
MRI does not involve ionizing radiation and no major risks are known with
regard to making a MRI. By participating in this MRI study SMART patients will
not experience direct benefits themselves, but with participation they will
contribute to scientific research in imaging of brown adipose tissue, which, in
the future might prove to be a valuable therapeutic target in obesity and
obesity related cardiovascular disease.
Heidelberglaan 100
Utrecht 3508 GA
NL
Heidelberglaan 100
Utrecht 3508 GA
NL
Listed location countries
Age
Inclusion criteria
Patients participating in the SMART cohort (protocol number 96-048).
Exclusion criteria
- Pregnancy or lactation.
- Mentally incapacitated subjects.
- Claustrophobia.
- Waist circumference >200cm.
- Metallic devices in the body of the participant such as cardioverter-defibrillators (AICD/ICD), pacemakers, cochlear implants, implanted insulin pumps, endoscopic (gastric) or aneurysm (brain) clips according to the UMCU MRI guidelines. (https://richtlijn.mijnumc.nl/Beeld/MRI/Documents/MRI%20Veiligheid%20MRI%20contra-indicaties.pdf)
- Patients with HIV infection.
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
Register | ID |
---|---|
CCMO | NL46994.041.13 |