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Investigating the Central and Peripheral Mechanisms by Which Glucocorticoids Affect Hunger

Primary Purpose

Obesity

Status
Completed
Phase
Phase 1
Locations
United States
Study Type
Interventional
Intervention
hydrocortisone
saline
Sponsored by
Yale University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional basic science trial for Obesity focused on measuring fMRI obesity

Eligibility Criteria

18 Years - 45 Years (Adult)All SexesAccepts Healthy Volunteers

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

Sites / Locations

  • Yale University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Placebo Comparator

Arm Label

Intravenous glucocorticoids

Intravenous saline

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

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.
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.

Secondary Outcome Measures

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.
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.
Total Cortisol
Total cortisol will be collected from serum at the beginning and end of the procedure.
Total Cortisol
Total cortisol will be collected from serum at the beginning and end of the procedure.
Free Cortisol
Free cortisol will be collected from serum at the beginning and end of the procedure.
Free Cortisol
Free cortisol will be collected from serum at the beginning and end of the procedure.
Cortisone
Cortisone will be collected from serum at the beginning and end of the procedure.
Cortisone
Cortisone will be collected from serum at the beginning and end of the procedure.
Adrenocorticotropic Hormone
Adrenocorticotropic Hormone (ACTH) will be collected from serum at the beginning and end of the procedure.
Adrenocorticotropic Hormone
Adrenocorticotropic Hormone (ACTH) will be collected from serum at the beginning and end of the procedure.
Glucose
Glucose will be collected from serum at the beginning and end of the procedure.
Glucose
Glucose will be collected from serum at the beginning and end of the procedure.
Glucagon
Glucagon will be collected from serum at the beginning and end of the procedure.
Glucagon
Glucagon will be collected from serum at the beginning and end of the procedure.
Insulin
Insulin will be collected from serum at the beginning and end of the procedure.
Insulin
Insulin will be collected from serum at the beginning and end of the procedure.
Leptin
Leptin will be collected from serum at the beginning and end of the procedure.
Leptin
Leptin will be collected from serum at the beginning and end of the procedure.
Ghrelin
Ghrelin will be collected from serum at the beginning and end of the procedure.
Ghrelin
Ghrelin will be collected from serum at the beginning and end of the procedure.
Neuropeptide Y
Neuropeptide Y (NPY) will be collected from serum at the beginning and end of the procedure.
Neuropeptide Y
Neuropeptide Y (NPY) will be collected from serum at the beginning and end of the procedure.
Glucagon-like peptide-1
Glucagon-like peptide-1 (GLP-1) will be collected from serum at the beginning and end of the procedure.
Glucagon-like peptide-1
Glucagon-like peptide-1 (GLP-1) will be collected from serum at the beginning and end of the procedure.

Full Information

First Posted
March 22, 2016
Last Updated
May 18, 2022
Sponsor
Yale University
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
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1. Study Identification

Unique Protocol Identification Number
NCT02722200
Brief Title
Investigating the Central and Peripheral Mechanisms by Which Glucocorticoids Affect Hunger
Official Title
Investigating the Central and Peripheral Mechanisms by Which Glucocorticoids Affect Hunger
Study Type
Interventional

2. Study Status

Record Verification Date
May 2022
Overall Recruitment Status
Completed
Study Start Date
May 2016 (undefined)
Primary Completion Date
July 19, 2017 (Actual)
Study Completion Date
July 19, 2017 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Yale University
Collaborators
National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Obesity
Keywords
fMRI obesity

7. Study Design

Primary Purpose
Basic Science
Study Phase
Phase 1
Interventional Study Model
Crossover Assignment
Masking
Participant
Allocation
Randomized
Enrollment
28 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Intravenous glucocorticoids
Arm Type
Experimental
Arm Description
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.
Arm Title
Intravenous saline
Arm Type
Placebo Comparator
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
hydrocortisone
Intervention Description
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.
Intervention Type
Other
Intervention Name(s)
saline
Intervention Description
Saline will be used as the placebo comparator. It will be administered in the same manner as the active drug.
Primary Outcome Measure Information:
Title
Change in Brain Response to Food Imagery
Description
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.
Time Frame
90 minutes
Title
Average Hunger Rating
Description
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.
Time Frame
90 minutes
Secondary Outcome Measure Information:
Title
Average Wanting Rating
Description
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.
Time Frame
90 minutes
Title
Average Liking Rating
Description
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.
Time Frame
90 minutes
Title
Total Cortisol
Description
Total cortisol will be collected from serum at the beginning and end of the procedure.
Time Frame
Baseline
Title
Total Cortisol
Description
Total cortisol will be collected from serum at the beginning and end of the procedure.
Time Frame
90 minutes
Title
Free Cortisol
Description
Free cortisol will be collected from serum at the beginning and end of the procedure.
Time Frame
Baseline
Title
Free Cortisol
Description
Free cortisol will be collected from serum at the beginning and end of the procedure.
Time Frame
90 minutes
Title
Cortisone
Description
Cortisone will be collected from serum at the beginning and end of the procedure.
Time Frame
Baseline
Title
Cortisone
Description
Cortisone will be collected from serum at the beginning and end of the procedure.
Time Frame
90 minutes
Title
Adrenocorticotropic Hormone
Description
Adrenocorticotropic Hormone (ACTH) will be collected from serum at the beginning and end of the procedure.
Time Frame
Baseline
Title
Adrenocorticotropic Hormone
Description
Adrenocorticotropic Hormone (ACTH) will be collected from serum at the beginning and end of the procedure.
Time Frame
90 minutes
Title
Glucose
Description
Glucose will be collected from serum at the beginning and end of the procedure.
Time Frame
Baseline
Title
Glucose
Description
Glucose will be collected from serum at the beginning and end of the procedure.
Time Frame
90 minutes
Title
Glucagon
Description
Glucagon will be collected from serum at the beginning and end of the procedure.
Time Frame
Baseline
Title
Glucagon
Description
Glucagon will be collected from serum at the beginning and end of the procedure.
Time Frame
90 minutes
Title
Insulin
Description
Insulin will be collected from serum at the beginning and end of the procedure.
Time Frame
Baseline
Title
Insulin
Description
Insulin will be collected from serum at the beginning and end of the procedure.
Time Frame
90 minutes
Title
Leptin
Description
Leptin will be collected from serum at the beginning and end of the procedure.
Time Frame
Baseline
Title
Leptin
Description
Leptin will be collected from serum at the beginning and end of the procedure.
Time Frame
90 minutes
Title
Ghrelin
Description
Ghrelin will be collected from serum at the beginning and end of the procedure.
Time Frame
Baseline
Title
Ghrelin
Description
Ghrelin will be collected from serum at the beginning and end of the procedure.
Time Frame
90 minutes
Title
Neuropeptide Y
Description
Neuropeptide Y (NPY) will be collected from serum at the beginning and end of the procedure.
Time Frame
Baseline
Title
Neuropeptide Y
Description
Neuropeptide Y (NPY) will be collected from serum at the beginning and end of the procedure.
Time Frame
90 minutes
Title
Glucagon-like peptide-1
Description
Glucagon-like peptide-1 (GLP-1) will be collected from serum at the beginning and end of the procedure.
Time Frame
Baseline
Title
Glucagon-like peptide-1
Description
Glucagon-like peptide-1 (GLP-1) will be collected from serum at the beginning and end of the procedure.
Time Frame
90 minutes

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
45 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility 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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Robert M Sherwin, MD
Organizational Affiliation
Yale University
Official's Role
Principal Investigator
Facility Information:
Facility Name
Yale University
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06511
Country
United States

12. IPD Sharing Statement

Plan to Share IPD
Undecided

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Investigating the Central and Peripheral Mechanisms by Which Glucocorticoids Affect Hunger

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