Ignite Creation Date:
2025-12-25 @ 2:54 AM
Ignite Modification Date:
2025-12-26 @ 1:35 AM
Study NCT ID:
NCT03414333
Status:
COMPLETED
Last Update Posted:
2018-07-19
First Post:
2018-01-15
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
To Determine the Effect of GLP1 on Cognitive Function, Brain Glucose Metabolism and Neuroplasticity.
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D009765', 'term': 'Obesity'}, {'id': 'D060825', 'term': 'Cognitive Dysfunction'}], 'ancestors': [{'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D050177', 'term': 'Overweight'}, {'id': 'D044343', 'term': 'Overnutrition'}, {'id': 'D009748', 'term': 'Nutrition Disorders'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D003072', 'term': 'Cognition Disorders'}, {'id': 'D019965', 'term': 'Neurocognitive Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D052216', 'term': 'Glucagon-Like Peptide 1'}], 'ancestors': [{'id': 'D004763', 'term': 'Glucagon-Like Peptides'}, {'id': 'D052336', 'term': 'Proglucagon'}, {'id': 'D005768', 'term': 'Gastrointestinal Hormones'}, {'id': 'D006728', 'term': 'Hormones'}, {'id': 'D006730', 'term': 'Hormones, Hormone Substitutes, and Hormone Antagonists'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NON_RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 14}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2016-06-29', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2018-07', 'completionDateStruct': {'date': '2018-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2018-07-18', 'studyFirstSubmitDate': '2018-01-15', 'studyFirstSubmitQcDate': '2018-01-22', 'lastUpdatePostDateStruct': {'date': '2018-07-19', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2018-01-29', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2017-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'cognitive Function', 'timeFrame': '6 months', 'description': 'cognitive function measured by Mini Mental State Examination (MMSE).'}], 'primaryOutcomes': [{'measure': 'sustained Weight Loss', 'timeFrame': '6 months', 'description': 'normalizing obesity-related comorbidities.'}], 'secondaryOutcomes': [{'measure': 'glycemic Control', 'timeFrame': '6 months', 'description': 'GLP-1 level controled'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['obesity', 'cognitive dysfunction'], 'conditions': ['Glucose Metabolism Disorders', 'Obesity', 'Degenerative Brain Disorder']}, 'referencesModule': {'references': [{'pmid': '35729365', 'type': 'DERIVED', 'citation': '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.'}]}, 'descriptionModule': {'briefSummary': '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:\n\n* cognitive function measured by Mini Mental State Examination (MMSE) and Mental Deterioration Battery(MDB).\n* brain glucose metabolism measured by FDG-CT/PET\n* 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.', 'detailedDescription': 'The research project will include two separate studies:\n\n1. In obese subjects undergoing RYGB to test the effect of chronic elevation of GLP1 levels, and\n2. 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:.\n\nMorbid Obese Subjects Group:\n\nThis study will consist in a single arm, non randomized, uncontrolled, single center before-and after RYGB in 15 morbid obese subjects.\n\nHealthy Subjects Group:\n\nThis study will consist in a single arm, non randomized, uncontrolled, single center study in 8 healthy subjects.\n\nThe primary endpoint are the changes in:\n\n* cognitive function measured by Mini Mental State Examination (MMSE) and Mental Deterioration Battery (MDB)\n* brain glucose metabolism measured by FDG-CT/PET\n* 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.\n\nMorbid 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.\n\nHealthy 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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:(Morbid Obese Subjects Group)\n\n1. Males and females undergoing bariatric surgery as per clinical management\n2. Age = 18-60 years\n3. BMI\\>35 Kg/m 2 and stable weight (± 3 lbs) over the preceding three months\n4. Normal Glucose Tolerance (HbA1c \\> 4.5 % and \\< 5.7%) or Type 2 diabetes (HbA1c \\>5.7 % and \\<10.0%)\n5. Stable eGFR (\\>60 ml/min/1.73 m2 )\n6. Drug naive for type 2 diabetes treatment or on stable dose more than 3 months with anti-diabetic agents other than DPP4-inhibitors, GLP1 receptor agonists, and insulin.\n7. Subjects are capable of giving informed consent\n\nInclusion Criteria (Healthy Subjects Group)\n\n1. Males and females\n2. Age = 18-60 years\n3. BMI 22-35 Kg/m 2 and stable weight (± 3 lbs) over the preceding three months\n4. Stable eGFR (\\>60 ml/min/1.73 m 2 )\n5. Normal Glucose Tolerance (HbA1c\\>4.5 % and\\< 5.7%)\n6. Subjects are capable of giving informed consent.\n\nExclusion Criteria:(both groups)\n\n1. Steroids treatment\n2. Psychiatric Disorders\n3. Mental Retardation\n4. Severe cognitive Impairment\n5. Neurodegenerative diseases\n6. Epilepsy\n7. Depression Treatment\n8. Traumatic Brain Injury over the preceding six months\n9. Liver function enzymes higher more than two times the upper limit\n10. Heart Failure (NYHA III-IV)\n11. Type 1 Diabetes\n12. Diabetic Ketoacidosis\n13. GFR\\<60 ml/min/1.73 m 2\n14. Donation of blood to a blood bank, blood transfusion, or participation in a clinical study requiring withdrawal of \\> 400 mL of blood during the 8 weeks prior to the enrollment visit and at least 8 weeks thereafter\n15. Women who are pregnant or breastfeeding\n16. Patient with a history or current evidence of any condition, therapy, laboratory abnormality, or other circumstance which, in the opinion of the investigator or coordinator, might pose an unacceptable risk to the patient or interfere with trial procedures.'}, 'identificationModule': {'nctId': 'NCT03414333', 'briefTitle': 'To Determine the Effect of GLP1 on Cognitive Function, Brain Glucose Metabolism and Neuroplasticity.', 'organization': {'class': 'OTHER', 'fullName': 'University of Pisa'}, 'officialTitle': 'The Effect of Glucagon-like Peptide-1 (GLP-1) on Cognitive and Non-cognitive Function in Human', 'orgStudyIdInfo': {'id': 'PRA 2016'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Roux-en- Y gastric bypass (RYGB)', 'description': '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.', 'interventionNames': ['Procedure: RYGB']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'GLP-1', 'description': 'GLP-1 is an intestinal hormone secreted in response to nutrients.', 'interventionNames': ['Drug: GLP-1']}], 'interventions': [{'name': 'RYGB', 'type': 'PROCEDURE', 'description': '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.', 'armGroupLabels': ['Roux-en- Y gastric bypass (RYGB)']}, {'name': 'GLP-1', 'type': 'DRUG', 'otherNames': ['gut hormone'], 'description': 'GLP-1 is an hormone secreted by gut in response to nutrients ingestion.', 'armGroupLabels': ['GLP-1']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Pisa', 'country': 'Italy', 'facility': 'Dept.Clinical and Experimental Medicine.Section of Diabetes.', 'geoPoint': {'lat': 43.70853, 'lon': 10.4036}}], 'overallOfficials': [{'name': 'Stefano Del Prato, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'University of Pisa'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'University of Pisa', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Clinical Resercher', 'investigatorFullName': 'Prof. Stefano Del Prato', 'investigatorAffiliation': 'University of Pisa'}}}}