Investigating the Role of Polyol Pathway in the Central Nervous System
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 138
- 试验地点
- 1
- 主要终点
- Metabolite Measurements by MRS
研究概览
简要总结
Patients will undergo magnetic resonance spectroscopy (MRS) scanning to noninvasively measure intracerebral and plasma metabolite levels at baseline and following 2 and 4 hours of hyperglycemia. Subjects will also undergo a lumbar puncture at a separate occasion to assess cerebrospinal fluid levels of metabolites.
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 55 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Type 2 DM with HbA1C treated with metformin, sulfonylurea, insulin, or combination OR age-matched, non-diabetic obese (BMI > 30 kg/m^2) OR age-matched lean, healthy control subjects (BMI < 25 kg/m^2)
- •Age 18-55
- •BMI 18-45 kg/m^2
排除标准
- •Creatinine > 1.5 mg/dL
- •Hgb < 10 mg/dL
- •ALT > 2.5 x ULN
- •Untreated thyroid disease
- •Uncontrolled Hypertension
- •Known Neurological Disorders
- •Untreated Psychiatric Disorders
- •Malignancy
- •Bleeding Disorders
- •Current or recent steroid use in last 3 months
- •Illicit drug use
- •Pregnancy, actively seeking pregnancy, or breastfeeding
- •Inability to enter MRI/MRS
研究组 & 干预措施
Subjects with Type 2 Diabetes
Type 2 DM subjects with HbA1C > 7.5% treated with metformin, sulfonylurea, insulin or combination
干预措施: Brain MRS during hyperglycemic clamp (Other)
Subjects with Type 2 Diabetes
Type 2 DM subjects with HbA1C > 7.5% treated with metformin, sulfonylurea, insulin or combination
干预措施: Analysis of Metabolites in cerebrospinal fluid (Other)
Non-Diabetic Obese
Age-matched, non-diabetic obese (BMI > 30 kg/m^3) individuals
干预措施: Brain MRS during hyperglycemic clamp (Other)
Non-Diabetic Obese
Age-matched, non-diabetic obese (BMI > 30 kg/m^3) individuals
干预措施: Analysis of Metabolites in cerebrospinal fluid (Other)
Lean, healthy control subjects
Age-matched, lean, healthy control subjects (BMI < 25 kkg/m^3)
干预措施: Brain MRS during hyperglycemic clamp (Other)
Lean, healthy control subjects
Age-matched, lean, healthy control subjects (BMI < 25 kkg/m^3)
干预措施: Analysis of Metabolites in cerebrospinal fluid (Other)
结局指标
主要结局
Metabolite Measurements by MRS
时间窗: 4 hours post hyperglycemia
metabolite levels will be measured by MRS
次要结局
- Hunger Ratings(4 hours post hyperglycemia)
- Satiety Ratings(4 hours post hyperglycemia)
- Cognitive State(4 hours post hyperglycemia)