NCT03414333

To Determine the Effect of GLP1 on Cognitive Function, Brain Glucose Metabolism and Neuroplasticity.

The Effect of Glucagon-like Peptide-1 (GLP-1) on Cognitive and Non-cognitive Function in Human

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 14 (actual)
• Sponsor: University of Pisa · Academic / Other
• Sex: All
• Age: 18 Years – 60 Years
• Healthy volunteers: Not accepted

Summary

To test the hypothesis that GLP1 can exert favourable effects on multiple aspects of brain function. To this purpose, the investigator determine whether chronic increase in GLP1 concentration as it occurs after bariatric surgery (Roux-en- Y Gastric Bypass) is associated with improvement in: * cognitive function measured by Mini Mental State Examination (MMSE) and Mental Deterioration Battery(MDB). * brain glucose metabolism measured by FDG-CT/PET * neuroplasticity measure by binocular rivalry and saccadic adaptation tests in morbid obese subjects. In order to discern the effect of GLP1 irrespective of changes in the metabolic milieu the investigator will test whether short-term GLP-1 infusion can modulate the same parameters in healthy subjects.

Detailed description

The research project will include two separate studies: 1. In obese subjects undergoing RYGB to test the effect of chronic elevation of GLP1 levels, and 2. In normal volunteers to test the acute effect of GLP1, irrespective of changes in the metabolic milieu In several aspects of brain function as detailed below:. Morbid Obese Subjects Group: This study will consist in a single arm, non randomized, uncontrolled, single center before-and after RYGB in 15 morbid obese subjects. Healthy Subjects Group: This study will consist in a single arm, non randomized, uncontrolled, single center study in 8 healthy subjects. The primary endpoint are the changes in: * cognitive function measured by Mini Mental State Examination (MMSE) and Mental Deterioration Battery (MDB) * brain glucose metabolism measured by FDG-CT/PET * neuroplasticity measure by binocular rivalry and saccadic adaptation tests six months after RYGB in morbid obese subjects and with elevation of circulating GLP1 levels in healthy subjects. Morbid obese subjects participating in this study will be evaluated before and 6 months after bariatric surgery which is routinely performed to treat morbid obesity. For the purpose of baseline assessment subjects will undergo 3 visits at 1 week interval. All test procedures will be repeated in two subsequent visits 6 months after surgery with body weight being stable. Therefore, participation in the study will require a total of 5 visit with a post-trial phone contact 2 weeks after completion for safety assessment. Healthy subjects will be recruited for determining the acute effect of GLP1 on brain function irrespective of changes in the metabolic milieu. The study will require participation in a total of 3 visits.

Conditions

• Glucose Metabolism Disorders
• Obesity
• Degenerative Brain Disorder

Interventions

Type	Name	Description
PROCEDURE	RYGB	RYGB is associated with a increase of circulating GLP-1 (up to ten-fold) especially in response to meal ingestion. This increased availability of GLP1 has been claimed to contribute to restoration of some of the beta-cell function.
DRUG	GLP-1	GLP-1 is an hormone secreted by gut in response to nutrients ingestion.

Timeline

• Start date: 2016-06-29
• Primary completion: 2017-06-01
• Completion: 2018-06-01
• First posted: 2018-01-29
• Last updated: 2018-07-19

Locations

1 site across 1 country: Italy