Status:
COMPLETED
To Determine the Effect of GLP1 on Cognitive Function, Brain Glucose Metabolism and Neuroplasticity.
Lead Sponsor:
University of Pisa
Conditions:
Glucose Metabolism Disorders
Obesity
Eligibility:
All Genders
18-60 years
Phase:
NA
Brief 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 oc...
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 effe...
Eligibility Criteria
Inclusion
- (Morbid Obese Subjects Group)
- Males and females undergoing bariatric surgery as per clinical management
- Age = 18-60 years
- BMI\>35 Kg/m 2 and stable weight (± 3 lbs) over the preceding three months
- Normal Glucose Tolerance (HbA1c \> 4.5 % and \< 5.7%) or Type 2 diabetes (HbA1c \>5.7 % and \<10.0%)
- Stable eGFR (\>60 ml/min/1.73 m2 )
- 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.
- Subjects are capable of giving informed consent
- Inclusion Criteria (Healthy Subjects Group)
- Males and females
- Age = 18-60 years
- BMI 22-35 Kg/m 2 and stable weight (± 3 lbs) over the preceding three months
- Stable eGFR (\>60 ml/min/1.73 m 2 )
- Normal Glucose Tolerance (HbA1c\>4.5 % and\< 5.7%)
- Subjects are capable of giving informed consent.
Exclusion
- (both groups)
- Steroids treatment
- Psychiatric Disorders
- Mental Retardation
- Severe cognitive Impairment
- Neurodegenerative diseases
- Epilepsy
- Depression Treatment
- Traumatic Brain Injury over the preceding six months
- Liver function enzymes higher more than two times the upper limit
- Heart Failure (NYHA III-IV)
- Type 1 Diabetes
- Diabetic Ketoacidosis
- GFR\<60 ml/min/1.73 m 2
- 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
- Women who are pregnant or breastfeeding
- 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.
Key Trial Info
Start Date :
June 29 2016
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
June 1 2018
Estimated Enrollment :
14 Patients enrolled
Trial Details
Trial ID
NCT03414333
Start Date
June 29 2016
End Date
June 1 2018
Last Update
July 19 2018
Active Locations (1)
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1
Dept.Clinical and Experimental Medicine.Section of Diabetes.
Pisa, Italy