Pilot study to test the feasibility of measuring glucose uptake in adipose tissue under hyperinsulinemic hypo- ande euglycaemic conditions to quantify the effect of hypoglycaemia on metabolic activity of adipose tissue (VAT, SAT and GFAT) in…
ID
Source
Brief title
Condition
- Glucose metabolism disorders (incl diabetes mellitus)
Synonym
Research involving
Sponsors and support
Intervention
Outcome measures
Primary outcome
FDG uptake in visceral, subcutaneous abdominal, and gluteofemoral adipose
tissue.
Secondary outcome
Not applicable.
Background summary
The metabolic function of different white adipose tissue depots in the body and
its role in the development of type 2 diabetes (T2D) remains unclear. Several
studies have used fluor-18 fluorodeoxyglucose positron emission tomography with
computed tomography (FDG PET/CT) to image the metabolic activity of different
adipose tissues in lean and obese healthy subjects and in patients with T2D
with or without euglycaemic hyperinsulinemic clamping, describing differences
in metabolic activity of visceral adipose tissue (VAT), subcutaneous adipose
tissue (SAT) and gluteal-femoral adipose tissue (GFAT). Recently, FDG PET/CT
showed high glucose uptake in VAT and SAT under unintentional hypoglycaemic
conditions in a non-diabetic patient. Evaluation of potential differences in
FDG uptake in white adipose tissue between healthy volunteers and T2D patients
and between VAT, SAT and GFAT in these subjects under hyperinsulinemic
hypoglycaemic conditions would be of great value in further exploring the
pathogenesis of insulin resistance in T2D.
Study objective
Pilot study to test the feasibility of measuring glucose uptake in adipose
tissue under hyperinsulinemic hypo- ande euglycaemic conditions to quantify the
effect of hypoglycaemia on metabolic activity of adipose tissue (VAT, SAT and
GFAT) in patients with T2D and healthy subjects by FDG PET/CT imaging, and
compare it with metabolic activity at euglycemia.
Study design
Pilot feasibility study.
Intervention
FDG PET/CT under hyperinsulinemic eu- or hypoglycemic clamp conditions.
Study burden and risks
Per subject one FDG PET/CT scan during a clamping procedure. The clamping
procedure will be performed under continuous supervision by an experienced
physician. Low radiation burden, comparable with the background radiation of a
person in the Netherlands during 3 years.
Geert Grooteplein-Zuid 10
Nijmegen 6525 GA
NL
Geert Grooteplein-Zuid 10
Nijmegen 6525 GA
NL
Listed location countries
Age
Inclusion criteria
Age>= 18 years
BMI 27-40
For healthy volunteers: Fasting blood glucose< 6.1 mmol/l, HbA1c< 42 mmol/mol (6%)
For patients with T2D: Clinical overt T2D, on a glucose-lowering diet or on oral glucose-lowering medication, stable and under control for minimal 2 years, HbA1c< 75 mmol/mol (9%)
Exclusion criteria
Renal dysfunction with MDRD< 60
Overt symptomatic neuropathy or proliferative retinopathy
A history of cardiovascular disease complications (myocardial infarction, stroke, peripheral artery disease)
Pregnancy or lactating
Receiving subcutaneous insulin
Incapability to provide informed consent
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 | NL44098.091.13 |