Investigating the Central and Peripheral Mechanisms by Which Glucocorticoids Affect Hunger
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 28
- 试验地点
- 1
- 主要终点
- Change in Brain Response to Food Imagery
研究概览
简要总结
The purpose of this study is to examine if glucocorticoids will change neural activation in regions of the corticolimbic-striatal system that regulate feeding.
详细描述
The primary hypothesis tested in this study will be to determine if that in response to food cues, glucocorticoids will change neural activation in regions of the corticolimbic-striatal system that regulate feeding. It is anticipate that these changes will correlate with hunger ratings and food intake. Further, this research will also examine if glucocorticoids will increase the basal metabolic rate and alter multiple systemic appetite-regulating hormones compared to saline. It is expected that these changes will correlate positively with hunger ratings and food intake as well.
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
- Single (Participant)
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
- •BMI < = 26 kg/m2
- •Ability to read and write English
排除标准
- •Creatinine > 1.5
- •Hgb < 10 mg/dL
- •ALT > 2.5 x ULN
- •Untreated thyroid disease
- •Uncontrolled or severe hypertension
- •Known neurological disorders
- •Diabetes or impaired glucose tolerance
- •Untreated or severe psychiatric disorders
- •Malignancy
- •Endogenous hypercortisolism
- •Addison's disease
- •Bleeding disorders
- •Current or recent steroid use in the last 3 months
- •Illicit drug use
- •Eating disorders
- •Drug or alcohol addiction
- •History of claustrophobia
- •Pregnancy
- •Breastfeeding
- •Contraindications to MRI
- •Use of any psychoactive medication within the past 3 months
研究组 & 干预措施
Intravenous glucocorticoids
Subjects in the glucocorticoids arm will receive an infusion of hydrocortisone overnight in the research unit prior to fMRI testing on either the first or second visit.
干预措施: hydrocortisone (Drug)
Intravenous saline
Subjects in the saline arm will receive an infusion of saline overnight in the research unit prior to fMRI testing on either the first or second visit.
干预措施: saline (Other)
结局指标
主要结局
Change in Brain Response to Food Imagery
时间窗: 90 minutes
Brain response to images of food either during hydrocortisone infusion or saline infusion will be measured through fMRI. Brain response is operationally defined as the change in functional MRI-measured blood oxygen levels in specific regions of the brain between the resting state and intervention state. The fMRI sequences last anywhere from 1-5 min. Total scan time will be approximately 90 minutes. The slices taken with each sequences equal 25-75. The outcome is a comparison between the resting oxygen levels and oxygen levels during the interventions. BioImage Suite software is used to categorize if there is a significance between the two levels at a p \< 0.05.
Average Hunger Rating
时间窗: 90 minutes
Average hunger rating will be captured using the Visual Food Cue Task. This standardized method presents a series of images consisting of high calorie food, low calorie food, and non-food pictures presented randomly across four runs during the fMRI session. Each picture will be presented only once in a randomized order for each participant. Participants will be instructed to rate their "hunger", "liking" and "wanting" of the item on a 9-point Likert scale utilizing a 4-key button box. The hunger, wanting, and liking scales are all rated on a scale of 1-9, 1 being the least and 9 being the most. These scores are presented as an average across measurement points during the fMRI. Every time a food image is shown, the rater provides a rating of hunger, wanting and liking of it- people will be shown approximately 40-60 photos.
次要结局
- Average Wanting Rating(90 minutes)
- Average Liking Rating(90 minutes)
- Adrenocorticotropic Hormone(90 minutes)
- Glucagon(90 minutes)
- Leptin(90 minutes)
- Cortisone(90 minutes)
- Glucose(90 minutes)
- Insulin(90 minutes)
- Neuropeptide Y(90 minutes)
- Total Cortisol(90 minutes)
- Free Cortisol(90 minutes)
- Ghrelin(90 minutes)
- Glucagon-like peptide-1(90 minutes)