obesitas adult onset diabetes diabetes mellitus type 2
Conditions
Interventions
We will investigate and compare all participants with respect to food(-related)
neuronal activity in central reward and satiety circuits by blood oxygen
level-dependent (BOLD) fMRI at 3 different oc
b) the GLP-1 receptor agonist
exenatide in combination with a GLP-1 receptor antagonist (exendin 9-39) or c)
saline. These infusions will be performed in randomized order, on three
separate days. T
Sponsors
Vrije Universiteit Medisch Centrum
Eligibility
Age
18 Years to 99 Years
Inclusion criteria
Inclusion criteria: For all 3 study groups: 1. age 18*70 years. 2. Men and women. For women, only postmenopausal women (as ascertained by serum FSH) will be included in order to avoid variations related to the menstrual cycle. 3.To promote comparability and to overcome the interference of lateralization, only right-handed persons will be included.;For the healthy lean subjects, inclusion criteria will be: 1.body-mass index (BMI) of 3 months prior to screening 2. BMI *30 kg/m2 3.HbA1c 6.5*8.5% (48-69 mmol/mol) 4.Treatment with metformin at a stable dose for at least 3 months.
Exclusion criteria
Exclusion criteria: In the obese T2DM patients, no blood glucose- and weight lowering agents will be allowed within 3 months before screening except for metformin. The normoglycemic lean and obese individuals will not be allowed to take blood glucose-lowering agents at any time before and during the study. For all individuals, exclusion criteria will be: 1.congestive heart failure (NYHA II-IV) 2.chronic renal failure (glomerular filtration rate
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Differences in neuronal activity in CNS reward and satiety circuits (including striatum, amygdala, orbitofrontal cortex, insula, hypothalamus), as represented by BOLD fMRI signal change from baseline (%) in response to food(-related) stimuli, between obese T2DM patients, normoglycemic obese individuals and normoglycemic healthy lean subjects. | — |
Secondary
| Measure | Time frame |
|---|---|
| -Differences in neuronal activity in CNS reward and satiety circuits (including striatum, amygdala, orbitofrontal cortex, insula, hypothalamus), as represented by BOLD fMRI signal change from baseline (%) in response to food(-related) stimuli, (Appendix 4) between the infusion of exenatide and the infusion of exenatide in combination with a GLP-1 receptor antagonist. -Feeding behavior, measured as quantitative (kcal) and qualitative (energy density as well as nutrient composition; carbohydrate/fat/protein) changes in food choice during a choice-buffet lunch, will be compared between groups and conditions. -Self-reported hunger, satiety, fullness and prospective food consumption, will be rated on 100 mm visual analogue scales before and after the meal. | — |
Countries
Netherlands
Outcome results
None listed