The Effect of Glucagon-like Peptide-1 (GLP-1) on Cognitive and Non-cognitive Function in Human
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 14
- 试验地点
- 1
- 主要终点
- sustained Weight Loss
研究概览
简要总结
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.
详细描述
The research project will include two separate studies:
- In obese subjects undergoing RYGB to test the effect of chronic elevation of GLP1 levels, and
- 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:
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •(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.
排除标准
- •(both groups)
- •Steroids treatment
- •Psychiatric Disorders
- •Mental Retardation
- •Severe cognitive Impairment
- •Neurodegenerative diseases
- •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.
研究组 & 干预措施
Roux-en- Y gastric bypass (RYGB)
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.
干预措施: RYGB (Procedure)
GLP-1
GLP-1 is an intestinal hormone secreted in response to nutrients.
干预措施: GLP-1 (Drug)
结局指标
主要结局
sustained Weight Loss
时间窗: 6 months
normalizing obesity-related comorbidities.
次要结局
- glycemic Control(6 months)
研究者
Prof. Stefano Del Prato
Clinical Resercher
University of Pisa