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| ID | Type | Description | Link |
|---|---|---|---|
| 2R01DK020495-42 | U.S. NIH Grant/Contract | View source |
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| Name | Class |
|---|---|
| National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) | NIH |
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The purpose of this study is to examine if glucocorticoids will change neural activation in regions of the corticolimbic-striatal system that regulate feeding.
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Intravenous glucocorticoids | Experimental | 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. |
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| Intravenous saline | Placebo Comparator | 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| hydrocortisone | Drug | Hydrocortisone will be used as the steroid of choice because it is bio-identical to cortisol and is subject to the same metabolism as cortisol. |
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| Measure | Description | Time Frame |
|---|---|---|
| Change in Brain Response to Food Imagery | 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. | 90 minutes |
| Average Hunger Rating | 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. | 90 minutes |
| Measure | Description | Time Frame |
|---|---|---|
| Average Wanting Rating | 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Robert M Sherwin, MD | Yale University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Yale University | New Haven | Connecticut | 06511 | United States |
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| ID | Term |
|---|---|
| D009765 | Obesity |
| ID | Term |
|---|---|
| D050177 | Overweight |
| D044343 | Overnutrition |
| D009748 | Nutrition Disorders |
| D009750 | Nutritional and Metabolic Diseases |
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| ID | Term |
|---|---|
| D006854 | Hydrocortisone |
| D012965 | Sodium Chloride |
| ID | Term |
|---|---|
| D011282 | Pregnenediones |
| D011283 | Pregnenes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 |
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| saline | Other | Saline will be used as the placebo comparator. It will be administered in the same manner as the active drug. |
|
| 90 minutes |
| Average Liking Rating | 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. | 90 minutes |
| Total Cortisol | Total cortisol will be collected from serum at the beginning and end of the procedure. | Baseline |
| Total Cortisol | Total cortisol will be collected from serum at the beginning and end of the procedure. | 90 minutes |
| Free Cortisol | Free cortisol will be collected from serum at the beginning and end of the procedure. | Baseline |
| Free Cortisol | Free cortisol will be collected from serum at the beginning and end of the procedure. | 90 minutes |
| Cortisone | Cortisone will be collected from serum at the beginning and end of the procedure. | Baseline |
| Cortisone | Cortisone will be collected from serum at the beginning and end of the procedure. | 90 minutes |
| Adrenocorticotropic Hormone | Adrenocorticotropic Hormone (ACTH) will be collected from serum at the beginning and end of the procedure. | Baseline |
| Adrenocorticotropic Hormone | Adrenocorticotropic Hormone (ACTH) will be collected from serum at the beginning and end of the procedure. | 90 minutes |
| Glucose | Glucose will be collected from serum at the beginning and end of the procedure. | Baseline |
| Glucose | Glucose will be collected from serum at the beginning and end of the procedure. | 90 minutes |
| Glucagon | Glucagon will be collected from serum at the beginning and end of the procedure. | Baseline |
| Glucagon | Glucagon will be collected from serum at the beginning and end of the procedure. | 90 minutes |
| Insulin | Insulin will be collected from serum at the beginning and end of the procedure. | Baseline |
| Insulin | Insulin will be collected from serum at the beginning and end of the procedure. | 90 minutes |
| Leptin | Leptin will be collected from serum at the beginning and end of the procedure. | Baseline |
| Leptin | Leptin will be collected from serum at the beginning and end of the procedure. | 90 minutes |
| Ghrelin | Ghrelin will be collected from serum at the beginning and end of the procedure. | Baseline |
| Ghrelin | Ghrelin will be collected from serum at the beginning and end of the procedure. | 90 minutes |
| Neuropeptide Y | Neuropeptide Y (NPY) will be collected from serum at the beginning and end of the procedure. | Baseline |
| Neuropeptide Y | Neuropeptide Y (NPY) will be collected from serum at the beginning and end of the procedure. | 90 minutes |
| Glucagon-like peptide-1 | Glucagon-like peptide-1 (GLP-1) will be collected from serum at the beginning and end of the procedure. | Baseline |
| Glucagon-like peptide-1 | Glucagon-like peptide-1 (GLP-1) will be collected from serum at the beginning and end of the procedure. | 90 minutes |
| D001835 |
| Body Weight |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |
| D015062 | 11-Hydroxycorticosteroids |
| D006889 | Hydroxycorticosteroids |
| D000305 | Adrenal Cortex Hormones |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D015065 | 17-Hydroxycorticosteroids |
| D002712 | Chlorides |
| D006851 | Hydrochloric Acid |
| D017606 | Chlorine Compounds |
| D007287 | Inorganic Chemicals |
| D017670 | Sodium Compounds |