Investigating the Central and Peripheral Mechanisms by Which Glucocorticoids Affect Hunger

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE1

Total Enrollment

28 participants

Study Classification

INTERVENTIONAL

Study Start Date

2016-05-31

Study Completion Date

2017-07-19

Brief Summary

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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.

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Detailed Description

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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

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Obesity

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

CROSSOVER

Primary Study Purpose

BASIC_SCIENCE

Blinding Strategy

SINGLE

Participants

Study Groups

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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.

Group Type EXPERIMENTAL

hydrocortisone

Intervention Type 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.

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.

Group Type PLACEBO_COMPARATOR

saline

Intervention Type OTHER

Saline will be used as the placebo comparator. It will be administered in the same manner as the active drug.

Interventions

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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.

Intervention Type DRUG

saline

Saline will be used as the placebo comparator. It will be administered in the same manner as the active drug.

Intervention Type OTHER

Eligibility Criteria

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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

Minimum Eligible Age

18 Years

Maximum Eligible Age

45 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

Yes