| Trial ID: | L6201 |
| Source ID: | NCT01363609
|
| Associated Drug: |
Liraglutide Treatment 12 Weeks
|
| Title: |
Effects of Glucagon Like Peptide-1(GLP-1) and Liraglutide on Brain Satiety and Reward Circuits and Feeding Behavior in Diabetes
|
| Acronym: |
LIBRA
|
| Status: |
COMPLETED
|
| Study Results: |
NO
|
| Results: |
|
| Conditions: |
Obesity|Type 2 Diabetes
|
| Interventions: |
DRUG: Liraglutide treatment 12 weeks|DRUG: insulin glargine treatment|DRUG: GLP-1 receptor antagonist
|
| Outcome Measures: |
Primary: food-stimuli related neuronal activity in reward and satiety circuits as represented by BOLD fMRI signal change from baseline (%), * differences between obese T2DM patients and healthy lean subjects food-stimuli related neuronal activity in reward and satiety circuits as represented by BOLD fMRI signal change from baseline (%) * the involvement of endogenous GLP-1 food-stimuli related neuronal activity in reward and satiety circuits as represented by BOLD fMRI signal change from baseline (%) * Effects of treatment with the GLP-1 analog liraglutide in obese patients with type 2 diabetes in food-stimuli related neuronal activity in reward and satiety circuits as represented by BOLD fMRI signal change from baseline (%) * - To investigate the involvement of the increased meal-related endogenous GLP-1 levels after gastric bypass surgery in these food-stimuli related CNS satiety and reward responses and to investigate whether pharmacological blocking of endogenous GLP-1 receptor activation, using a GLP-1 antagonist, differentially affects these responses before and after gastric bypass surgery in obese individuals., approximately 3 years | Secondary: GLP-1 analog treatment related changes in obese patients with type 2 diabetes in self-reported hunger, satiety, fullness, approximately 3 years|GLP-1 analog treatment related changes in obese patients with type 2 diabetes in basal metabolic rate and post-prandial energy expenditure, approximately 3 years|GLP-1 analog treatment related changes in obese patients with type 2 diabetes in microvascular function and vasomotion, approximately 3 years|GLP-1 analog treatment related changes in obese patients with type 2 diabetes in cardiovascular autonomic nervous balance, approximately 3 years|GLP-1 analog treatment related changes in obese patients with type 2 diabetes in concomitant changes in metabolic and humoral markers, approximately 3 years|Alterations in resting state brain activity networks in obese patients with type 2 diabetes compared to lean, healthy individuals and the involvement of endogenous GLP-1, approximately 3 years|Alterations in brain arterial blood flow in obese patients with type 2 diabetes compared to lean, healthy individuals and the involvement of endogenous GLP-1, approximately 3 years|GLP-1 analog treatment related changes in obese patients with type 2 diabetes in resting state brain activity networks., approximately 3 years|GLP-1 analog treatment related changes in obese patients with type 2 diabetes in brain arterial blood flow., approximately 3 years
|
| Sponsor/Collaborators: |
Sponsor: Amsterdam UMC, location VUmc
|
| Gender: |
ALL
|
| Age: |
ADULT, OLDER_ADULT
|
| Phases: |
|
| Enrollment: |
50
|
| Study Type: |
INTERVENTIONAL
|
| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: CROSSOVER|Masking: NONE|Primary Purpose:
|
| Start Date: |
2011-10
|
| Completion Date: |
2015-01
|
| Results First Posted: |
|
| Last Update Posted: |
2015-02-18
|
| Locations: |
VU University Medical Center, Amsterdam, 1081 HV, Netherlands
|
| URL: |
https://clinicaltrials.gov/show/NCT01363609
|
