1. FDG PET scanning will permit evaluation of atherosclerotic disease in lower limbs (both density and activity of macrophages in local plaques) in patients with diabetes type 2 2. To obtain a more precise identification of ischemic borders…
ID
Source
Brief title
Condition
- Arteriosclerosis, stenosis, vascular insufficiency and necrosis
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
1. Assessment of FDG uptake by PET imaging along plaques in the distal
vasculature of the lower limbs that is compared with presence of
atherosclerotic lesions within the same individual (as determined by
conventional CT scanning).
2. Difference in the distribution of FDG uptake by endothelium (at baseline vs.
after temporary occlusion by use of a tourniquet for 3 minutes) for each
predefined segment along the distal vasculature.
Secondary outcome
1. To evaluate whether FDG uptake significantly correlates to vascular plaques
on CT
2. To evaluate whether a FDG PET-derived ischemic border zone correlate with
conventional clinical scores of ischemia
Background summary
A significant reduction in microvascular disease is attained due to recent
efforts in both screening programmes and therapy in patients with type 2
diabetes. Despite this success, major cause of both morbidity and mortality in
type 2 diabetes is currently macrovascular disease with its ischemic
complications. New developments in the field of nuclear medicine will extend
opportunities to evaluate tissue structures through its functional properties
(isotope scanning) and no more just its anatomical borders (CT scanning).
Combination of both functionality and anatomy may give rise to new approaches
that test tissue viability and this modality may be of great support in the
evaluation of microvasculature and macrovasculature in high risk cardiovascular
patients, like in the presence of type 2 diabetes. In regions of local ischemia
and its borderzones along the vasculature, arteriogenesis is sprouting as a
local rescue mechanism and with detection of these regions we may identify
regions in which vessel re-growth is permissive with a subsequent repair of
impaired circulation. Within some time, several therapeutic interventions are
expected to be introduced (such as fibroblast growth factor (FGF))
interventions, actually in phase II clinical research) and a tool, such as
fluorodeoxyglucose (FDG) PET CT scanning could be useful in evaluation of
follow up after intervention with these new compounds.
Study objective
1. FDG PET scanning will permit evaluation of atherosclerotic disease in lower
limbs (both density and activity of macrophages in local plaques) in patients
with diabetes type 2
2. To obtain a more precise identification of ischemic borders concerning
critical limb ischemia along the vasculature of the lower limb in patients
with diabetes type 2.
Study design
Pilot observational study
Study burden and risks
Each participant will be submitted to radiation burden by the use of FDG PET/CT
scanning. However, to reduce the radiation dose, only low-dose CT scans will be
acquired, and the total amount of radiation exposure will be limited to
approximately 10.4 mSv). Moreover, no intravenous or oral CT-contrast will be
used. The use of the tourniquet is not described as harmful and this method has
been used for several times in the clinical work-up of significant impaired
distal circulation. If a functional anatomical evaluation method will become
available to the clinic, a better scoring of the diabetic microvasculature and
macrovasculature could be performed and this can be of enormous support during
the clinical follow up after therapeutic interventions and during preparation
of invasive procedures to restore optimal distal flow.
meibergdreef 9
1100 DD Amsterdam
Nederland
meibergdreef 9
1100 DD Amsterdam
Nederland
Listed location countries
Age
Inclusion criteria
type 2 diabetes,
presence of an threatened distal circulation
no smoking.
Exclusion criteria
pregnancy or an actual wish for pregnancy
lactation period
less than a year in the postmenopausal state
HbA1c > 11%
at random glucose level more than 12 mmol/l at time of FGDPET scan.
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 | NL26561.018.09 |