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

• Status: Completed
• Trial end date: 2018-06-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: N/A
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: University of Pisa
• Treatments: Glucagon; Glucagon-Like Peptide 1; Hormones

Criteria

Inclusion Criteria:(Morbid Obese Subjects Group)

1. Males and females undergoing bariatric surgery as per clinical management

2. Age = 18-60 years

3. BMI>35 Kg/m 2 and stable weight (± 3 lbs) over the preceding three months

4. Normal Glucose Tolerance (HbA1c > 4.5 % and < 5.7%) or Type 2 diabetes (HbA1c >5.7 % and <10.0%)

5. Stable eGFR (>60 ml/min/1.73 m2 )

6. 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.

7. Subjects are capable of giving informed consent

Inclusion Criteria (Healthy Subjects Group)

1. Males and females

2. Age = 18-60 years

3. BMI 22-35 Kg/m 2 and stable weight (± 3 lbs) over the preceding three months

4. Stable eGFR (>60 ml/min/1.73 m 2 )

5. Normal Glucose Tolerance (HbA1c>4.5 % and< 5.7%)

6. Subjects are capable of giving informed consent.

Exclusion Criteria:(both groups)

1. Steroids treatment

2. Psychiatric Disorders

3. Mental Retardation

4. Severe cognitive Impairment

5. Neurodegenerative diseases

6. Epilepsy

7. Depression Treatment

8. Traumatic Brain Injury over the preceding six months

9. Liver function enzymes higher more than two times the upper limit

10. Heart Failure (NYHA III-IV)

11. Type 1 Diabetes

12. Diabetic Ketoacidosis

13. GFR<60 ml/min/1.73 m 2

14. 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

15. Women who are pregnant or breastfeeding

16. 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.