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Investigating the Central and Peripheral Mechanisms by Which Glucocorticoids Affect Hunger

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ClinicalTrials.gov Identifier: NCT02722200
Recruitment Status : Active, not recruiting
First Posted : March 29, 2016
Last Update Posted : October 23, 2017
Sponsor:
Information provided by (Responsible Party):
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.

Condition or disease Intervention/treatment Phase
Obesity Drug: hydrocortisone Other: saline Phase 1

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.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 16 participants
Allocation: Randomized
Intervention Model: Crossover Assignment
Masking: Single (Participant)
Primary Purpose: Basic Science
Official Title: Investigating the Central and Peripheral Mechanisms by Which Glucocorticoids Affect Hunger
Study Start Date : May 2016
Estimated Primary Completion Date : November 2018
Estimated Study Completion Date : November 2018


Arm Intervention/treatment
Experimental: 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.
Drug: hydrocortisone
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.

Placebo Comparator: 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.
Other: saline
Saline will be used as the placebo comparator. It will be administered in the same manner as the active drug.




Primary Outcome Measures :
  1. Change in Brain Response to Food Imagery [ Time Frame: 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.


  2. Average Hunger Rating [ Time Frame: 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 :
  1. Average Wanting Rating [ Time Frame: 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.

  2. Average Liking Rating [ Time Frame: 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.

  3. Total Cortisol [ Time Frame: Baseline ]
    Total cortisol will be collected from serum at the beginning and end of the procedure.

  4. Total Cortisol [ Time Frame: 90 minutes ]
    Total cortisol will be collected from serum at the beginning and end of the procedure.

  5. Free Cortisol [ Time Frame: Baseline ]
    Free cortisol will be collected from serum at the beginning and end of the procedure.

  6. Free Cortisol [ Time Frame: 90 minutes ]
    Free cortisol will be collected from serum at the beginning and end of the procedure.

  7. Cortisone [ Time Frame: Baseline ]
    Cortisone will be collected from serum at the beginning and end of the procedure.

  8. Cortisone [ Time Frame: 90 minutes ]
    Cortisone will be collected from serum at the beginning and end of the procedure.

  9. Adrenocorticotropic Hormone [ Time Frame: Baseline ]
    Adrenocorticotropic Hormone (ACTH) will be collected from serum at the beginning and end of the procedure.

  10. Adrenocorticotropic Hormone [ Time Frame: 90 minutes ]
    Adrenocorticotropic Hormone (ACTH) will be collected from serum at the beginning and end of the procedure.

  11. Glucose [ Time Frame: Baseline ]
    Glucose will be collected from serum at the beginning and end of the procedure.

  12. Glucose [ Time Frame: 90 minutes ]
    Glucose will be collected from serum at the beginning and end of the procedure.

  13. Glucagon [ Time Frame: Baseline ]
    Glucagon will be collected from serum at the beginning and end of the procedure.

  14. Glucagon [ Time Frame: 90 minutes ]
    Glucagon will be collected from serum at the beginning and end of the procedure.

  15. Insulin [ Time Frame: Baseline ]
    Insulin will be collected from serum at the beginning and end of the procedure.

  16. Insulin [ Time Frame: 90 minutes ]
    Insulin will be collected from serum at the beginning and end of the procedure.

  17. Leptin [ Time Frame: Baseline ]
    Leptin will be collected from serum at the beginning and end of the procedure.

  18. Leptin [ Time Frame: 90 minutes ]
    Leptin will be collected from serum at the beginning and end of the procedure.

  19. Ghrelin [ Time Frame: Baseline ]
    Ghrelin will be collected from serum at the beginning and end of the procedure.

  20. Ghrelin [ Time Frame: 90 minutes ]
    Ghrelin will be collected from serum at the beginning and end of the procedure.

  21. Neuropeptide Y [ Time Frame: Baseline ]
    Neuropeptide Y (NPY) will be collected from serum at the beginning and end of the procedure.

  22. Neuropeptide Y [ Time Frame: 90 minutes ]
    Neuropeptide Y (NPY) will be collected from serum at the beginning and end of the procedure.

  23. Glucagon-like peptide-1 [ Time Frame: Baseline ]
    Glucagon-like peptide-1 (GLP-1) will be collected from serum at the beginning and end of the procedure.

  24. Glucagon-like peptide-1 [ Time Frame: 90 minutes ]
    Glucagon-like peptide-1 (GLP-1) will be collected from serum at the beginning and end of the procedure.



Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years to 45 Years   (Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Criteria

Inclusion Criteria:

  • BMI < = 26 kg/m2
  • Ability to read and write English

Exclusion Criteria:

  • 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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02722200


Locations
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United States, Connecticut
Yale University
New Haven, Connecticut, United States, 06511
Sponsors and Collaborators
Yale University
Investigators
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Principal Investigator: Robert M Sherwin, MD Yale University

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Responsible Party: Yale University
ClinicalTrials.gov Identifier: NCT02722200     History of Changes
Other Study ID Numbers: 1510016716
First Posted: March 29, 2016    Key Record Dates
Last Update Posted: October 23, 2017
Last Verified: October 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

Keywords provided by Yale University:
fMRI obesity

Additional relevant MeSH terms:
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Hydrocortisone
Hydrocortisone 17-butyrate 21-propionate
Hydrocortisone acetate
Hydrocortisone hemisuccinate
Glucocorticoids
Anti-Inflammatory Agents
Hormones
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs