Investigating the Central and Peripheral Mechanisms by Which Glucocorticoids Affect Hunger
- Registration Number
- NCT02722200
- Lead Sponsor
- Yale University
- Brief Summary
The purpose of this study is to examine if glucocorticoids will change neural activation in regions of the corticolimbic-striatal system that regulate feeding.
- Detailed Description
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.
Recruitment & Eligibility
- Status
- COMPLETED
- Sex
- All
- Target Recruitment
- 28
- BMI < = 26 kg/m2
- Ability to read and write English
- 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
- Smoking
- 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
Study & Design
- Study Type
- INTERVENTIONAL
- Study Design
- CROSSOVER
- Arm && Interventions
Group Intervention Description Intravenous saline 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. Intravenous glucocorticoids hydrocortisone 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.
- Primary Outcome Measures
Name Time Method Change in Brain Response to Food Imagery 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 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.
- Secondary Outcome Measures
Name Time Method Average Wanting Rating 90 minutes Average wanting 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.
Average Liking Rating 90 minutes Average wanting 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.
Adrenocorticotropic Hormone 90 minutes Adrenocorticotropic Hormone (ACTH) will be collected from serum at the beginning and end of the procedure.
Glucagon 90 minutes Glucagon will be collected from serum at the beginning and end of the procedure.
Leptin 90 minutes Leptin will be collected from serum at the beginning and end of the procedure.
Cortisone 90 minutes Cortisone will be collected from serum at the beginning and end of the procedure.
Glucose 90 minutes Glucose will be collected from serum at the beginning and end of the procedure.
Insulin 90 minutes Insulin will be collected from serum at the beginning and end of the procedure.
Neuropeptide Y 90 minutes Neuropeptide Y (NPY) will be collected from serum at the beginning and end of the procedure.
Total Cortisol 90 minutes Total cortisol will be collected from serum at the beginning and end of the procedure.
Free Cortisol 90 minutes Free cortisol will be collected from serum at the beginning and end of the procedure.
Ghrelin 90 minutes Ghrelin will be collected from serum at the beginning and end of the procedure.
Glucagon-like peptide-1 90 minutes Glucagon-like peptide-1 (GLP-1) will be collected from serum at the beginning and end of the procedure.
Trial Locations
- Locations (1)
Yale University
🇺🇸New Haven, Connecticut, United States