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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:
The research project will include two separate studies:
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:
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Roux-en- Y gastric bypass (RYGB) | Experimental | Roux-en- Y gastric bypass (RYGB) is the most popular bariatric procedure and it has been associated with improvements in glycemic control and cognitive function. It works by decreasing the amount of food you can eat at one sitting and by changing the hormones released at the bottom of the stomach and duodenum.we propose that RYGB is a model of chronic elevation of GLP-1 providing an opportunity to explore relationship between changes in the circulating hormone and brain glucose metabolism, cognitive function and neuroplasticity. |
|
| GLP-1 | Active Comparator | GLP-1 is an intestinal hormone secreted in response to nutrients. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| RYGB | Procedure | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| sustained Weight Loss | normalizing obesity-related comorbidities. | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| glycemic Control | GLP-1 level controled | 6 months |
| Measure | Description | Time Frame |
|---|---|---|
| cognitive Function | cognitive function measured by Mini Mental State Examination (MMSE). | 6 months |
Inclusion Criteria:(Morbid Obese Subjects Group)
Inclusion Criteria (Healthy Subjects Group)
Exclusion Criteria:(both groups)
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| Name | Affiliation | Role |
|---|---|---|
| Stefano Del Prato, MD | University of Pisa | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dept.Clinical and Experimental Medicine.Section of Diabetes. | Pisa | Italy |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 35729365 | Derived | Dardano A, Aghakhanyan G, Moretto C, Ciccarone A, Bellini R, Sancho Bornez V, Ceccarini G, Santini F, Volterrani D, Del Prato S, Daniele G. Brain effect of bariatric surgery in people with obesity. Int J Obes (Lond). 2022 Sep;46(9):1671-1677. doi: 10.1038/s41366-022-01162-8. Epub 2022 Jun 21. |
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| ID | Term |
|---|---|
| D044882 | Glucose Metabolism Disorders |
| D009765 | Obesity |
| D060825 | Cognitive Dysfunction |
| ID | Term |
|---|---|
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D050177 | Overweight |
| D044343 | Overnutrition |
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| ID | Term |
|---|---|
| D052216 | Glucagon-Like Peptide 1 |
| ID | Term |
|---|---|
| D004763 | Glucagon-Like Peptides |
| D052336 | Proglucagon |
| D005768 | Gastrointestinal Hormones |
| D006728 | Hormones |
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| GLP-1 | Drug | GLP-1 is an hormone secreted by gut in response to nutrients ingestion. |
|
|
| D009748 |
| Nutrition Disorders |
| D001835 | Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D003072 | Cognition Disorders |
| D019965 | Neurocognitive Disorders |
| D001523 | Mental Disorders |
| D006730 |
| Hormones, Hormone Substitutes, and Hormone Antagonists |