| Trial ID: | L6397 |
| Source ID: | NCT01281228
|
| Associated Drug: |
Exenatide
|
| Title: |
The Effect of GLP-1 Receptor Activation on Central Reward and Satiety in Obesity and Diabetes
|
| Acronym: |
Braini-Ex
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Diabetes Mellitus|Diabetes Mellitus, Type 2|Obesity
|
| Interventions: |
DRUG: exenatide|DRUG: exenatide + exendin (9-39)|DRUG: placebo
|
| Outcome Measures: |
Primary: Differences in neuronal activity in CNS reward and satiety circuits, 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., 1 hour | Secondary: Feeding behavior, 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., 2 hours|Self-reported hunger, Self-reported hunger, satiety, fullness and prospective food consumption, will be rated on 100 mm visual analogue scales before and after the meal., 2 hours
|
| Sponsor/Collaborators: |
Sponsor: Amsterdam UMC, location VUmc | Collaborators: Eli Lilly and Company|Bristol-Myers Squibb
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
|
| Enrollment: |
48
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: SINGLE (PARTICIPANT)|Primary Purpose:
|
| Start Date: |
2011-09
|
| Completion Date: |
2013-10
|
| Results First Posted: |
|
| Last Update Posted: |
2015-06-03
|
| Locations: |
VU University Medical Center, Amsterdam, De Boelelaan 1117, 1007MB, Netherlands
|
| URL: |
https://clinicaltrials.gov/show/NCT01281228
|
