Hypothalamic fMRI Response to Nutrients
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 56
- 试验地点
- 1
- 主要终点
- The primary outcomes of this aim will be the change in fMRI response in the hypothalamus to IV glucose, to IV glucose during intralipid infusion, and to the IV glucose alone, in the lean and obese groups separately.
研究概览
简要总结
The purpose of this study is to identify how certain parts of the brain that control appetite respond to changes in dietary carbohydrate and fat.
详细描述
To measure fMRI signal change in hypothalamic and brainstem centers associated with control of food intake and energy expenditure in response to IV glucose, fructose, and saline. The fMRI response to these nutrients will then be compared in obese vs. lean subjects. Frequently timed blood samples will be obtained for measurement of nutrients (i.e., glucose) and blood levels of other factors (i.e., insulin, ghrelin, lactate) during these infusion protocols, and to test associations between these levels and the fMRI response.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Crossover
- 主要目的
- Basic Science
- 盲法
- Double (Participant, Investigator)
入排标准
- 年龄范围
- 18 Years 至 45 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age 18 year to 45 years of age
- •BMI 18 to 25 kg/m2 (25 subjects) and 30 to 40 kg/m2 (25 subjects), matched for age and sex.
- •At maximal lifetime weight.
- •Weight stable for at least 3 months.
排除标准
- •Those with a major medical illness or who require prescription medication, including: cancer, coronary artery disease, hypertension, and diabetes.
- •Subjects taking psychiatric or centrally-acting (CNS) medications, or who are diagnosed with a psychiatric or neurological illness, including: depression, anorexia, bulimia, and seizure disorder.
- •Subjects who have lost weight as a result of dieting, pharmacological treatment, or bariatric surgery.
- •Weight > 350 lbs or girth > 60 inches (the limits of the MR machine)
- •Exercise > 30 minutes, 3 times a week.
- •Alcohol consumption > 2 drinks / day.
- •Weight > 300 lbs (150 kg) (weight limit for MR machine).
- •Blood glucose > 100 mg/dL, abnormal creatinine or liver function tests.
- •Illicit drug use.
- •Pregnancy.
- •Extreme dietary habits as determined by a GCRC nutritionist: very high or low dietary carbohydrate, protein, or fat intakes.
- •Those with a contraindication to exposure to strong magnetic fields: presence of metal in the body such as body piercing, shrapnel, cardiac pacemakers or aneurysm clips.
- •Those with claustrophobia.
研究组 & 干预措施
Saline
干预措施: saline (Dietary Supplement)
Fructose
干预措施: fructose (Dietary Supplement)
Glucose
IV glucose
干预措施: glucose (Dietary Supplement)
结局指标
主要结局
The primary outcomes of this aim will be the change in fMRI response in the hypothalamus to IV glucose, to IV glucose during intralipid infusion, and to the IV glucose alone, in the lean and obese groups separately.
时间窗: 0,1,2 and 3 months
次要结局
未报告次要终点
研究者
Jonathan Purnell
Principal Investigator
Oregon Health and Science University