ObesityPhase 1NCT02722200
Investigating the Central and Peripheral Mechanisms by Which Glucocorticoids Affect Hunger
A Phase 1 study testing hydrocortisone and saline in people with Obesity, run by Yale University at 1 site in United States.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 45 yearsHealthy volunteers can take part
- Conditions the study is for
- Obesity
- What is being tested?
- hydrocortisone and saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 28 participants
- Where
- 1 siteUnited States
- Study dates
- May 2016to 19 Jul 2017
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 45 years
- All sexes
- Healthy volunteers accepted
- Adult
Who may be able to join
- BMI < = 26 kg/m2
- Ability to read and write English
Who cannot join
- Creatinine > 1.5
- Hgb < 10 mg/dL
- ALT > 2.5 x ULN
- Untreated thyroid disease
- Uncontrolled or severe hypertension
- Known neurological disorders
Show all 22Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
The purpose of this study is to examine if glucocorticoids will change neural activation in regions of the corticolimbic-striatal system that regulate feeding.
Read the 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.
- Conditions
- Obesity
- Being tested
- hydrocortisone, saline
- Keywords
- fMRI obesity
- Medical subject headings
- Obesity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
hydrocortisoneDrug
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.
salineOther
Saline will be used as the placebo comparator. It will be administered in the same manner as the active drug.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: hydrocortisone |
| 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. Receives: Other: saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: 90 minutes
Secondary outcomes (24)
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.
Measured: 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.
Measured: 90 minutes
Total Cortisol
Total cortisol will be collected from serum at the beginning and end of the procedure.
Measured: Baseline
Total Cortisol
Total cortisol will be collected from serum at the beginning and end of the procedure.
Measured: 90 minutes
Free Cortisol
Free cortisol will be collected from serum at the beginning and end of the procedure.
Measured: Baseline
Free Cortisol
Free cortisol will be collected from serum at the beginning and end of the procedure.
Measured: 90 minutes
Cortisone
Cortisone will be collected from serum at the beginning and end of the procedure.
Measured: Baseline
Cortisone
Cortisone will be collected from serum at the beginning and end of the procedure.
Measured: 90 minutes
Adrenocorticotropic Hormone
Adrenocorticotropic Hormone (ACTH) will be collected from serum at the beginning and end of the procedure.
Measured: Baseline
Adrenocorticotropic Hormone
Adrenocorticotropic Hormone (ACTH) will be collected from serum at the beginning and end of the procedure.
Measured: 90 minutes
Glucose
Glucose will be collected from serum at the beginning and end of the procedure.
Measured: Baseline
Glucose
Glucose will be collected from serum at the beginning and end of the procedure.
Measured: 90 minutes
Glucagon
Glucagon will be collected from serum at the beginning and end of the procedure.
Measured: Baseline
Glucagon
Glucagon will be collected from serum at the beginning and end of the procedure.
Measured: 90 minutes
Insulin
Insulin will be collected from serum at the beginning and end of the procedure.
Measured: Baseline
Insulin
Insulin will be collected from serum at the beginning and end of the procedure.
Measured: 90 minutes
Leptin
Leptin will be collected from serum at the beginning and end of the procedure.
Measured: Baseline
Leptin
Leptin will be collected from serum at the beginning and end of the procedure.
Measured: 90 minutes
Ghrelin
Ghrelin will be collected from serum at the beginning and end of the procedure.
Measured: Baseline
Ghrelin
Ghrelin will be collected from serum at the beginning and end of the procedure.
Measured: 90 minutes
Neuropeptide Y
Neuropeptide Y (NPY) will be collected from serum at the beginning and end of the procedure.
Measured: Baseline
Neuropeptide Y
Neuropeptide Y (NPY) will be collected from serum at the beginning and end of the procedure.
Measured: 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.
Measured: Baseline
Glucagon-like peptide-1
Glucagon-like peptide-1 (GLP-1) will be collected from serum at the beginning and end of the procedure.
Measured: 90 minutes
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted29 Mar 2016 (estimated)
- Study startMay 2016
- Primary completion19 Jul 2017
- Study completion19 Jul 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for ObesityStudies of the same condition, open and under way.
- More trials run by Yale UniversityThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 28 participants (actual)
Sponsor and investigators
- Lead sponsor
- Yale University
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Robert M Sherwin, MD, Principal investigator, Yale University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02722200
- Sponsor's protocol ID
- 1510016716
- Other IDs
- 2R01DK020495-42
- Status last verified
- May 2022
- First submitted
- 22 Mar 2016
- Last updated
- 25 May 2022
- Results posted
- No
- Data monitoring committee
- Yes
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 25 May 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Central and Peripheral Mechanisms by Which Glucocorticoids Affect Hunger
- ClinicalTrials.gov ID
- NCT02722200
- Acronym / sponsor ID
- 1510016716
- Conditions
- Obesity
- Keywords
- fMRI obesity
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 28 participants (actual)
- Lead sponsor
- Yale UniversityUniversity, hospital or other
- Collaborators
- National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
- Study start
- May 2016
- Primary completion
- 19 Jul 2017 (actual)
- Study completion
- 19 Jul 2017 (actual)
- First posted
- 29 Mar 2016 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Basic science
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Intravenous glucocorticoids | Experimental | Drug: hydrocortisoneSubjects 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. |
| Intravenous saline | Placebo comparator | Other: salineSubjects 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. |
Who may qualify
- Ages
- 18 to 45 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult
Key inclusion criteria (2 listed)
- BMI < = 26 kg/m2
- Ability to read and write English
Key exclusion criteria (22 listed)
- Creatinine > 1.5
- Hgb < 10 mg/dL
- ALT > 2.5 x ULN
- Untreated thyroid disease
- Uncontrolled or severe hypertension
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| hydrocortisoneHydrocortisone will be used as the steroid of choice because it is bio-identical to cortisol and is subject to the same metabolism as cortisol. | Drug | Intravenous glucocorticoids |
| salineSaline will be used as the placebo comparator. It will be administered in the same manner as the active drug. | Other | Intravenous saline |
Primary outcome
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.
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.
24 secondary outcomes
Average Wanting Rating
Time frame: 90 minutes
Average Liking Rating
Time frame: 90 minutes
Total Cortisol
Time frame: Baseline
Total Cortisol
Time frame: 90 minutes
Free Cortisol
Time frame: Baseline
Free Cortisol
Time frame: 90 minutes
Cortisone
Time frame: Baseline
Cortisone
Time frame: 90 minutes
Adrenocorticotropic Hormone
Time frame: Baseline
Adrenocorticotropic Hormone
Time frame: 90 minutes
Glucose
Time frame: Baseline
Glucose
Time frame: 90 minutes
Glucagon
Time frame: Baseline
Glucagon
Time frame: 90 minutes
Insulin
Time frame: Baseline
Insulin
Time frame: 90 minutes
Leptin
Time frame: Baseline
Leptin
Time frame: 90 minutes
Ghrelin
Time frame: Baseline
Ghrelin
Time frame: 90 minutes
Neuropeptide Y
Time frame: Baseline
Neuropeptide Y
Time frame: 90 minutes
Glucagon-like peptide-1
Time frame: Baseline
Glucagon-like peptide-1
Time frame: 90 minutes
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 25 May 2022.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Robert M Sherwin, MD principal investigator
Yale University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing hydrocortisone and saline in people with Obesity, run by Yale University at 1 site in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 22 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 25 May 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in Brain Response to Food Imagery (time frame: 90 minutes). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 May 2022.