Clinical trial NCT02722200: 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
Overall status: COMPLETED
Phase: PHASE1
Conditions: Obesity
Keywords: fMRI obesity
Lead sponsor: Yale University
Sponsor class: OTHER
Collaborators: name: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
First posted: 2016-03-29
Enrollment: 28
Sex: ALL
Minimum age (years): 18
Maximum age (years): 45
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: CROSSOVER
Primary purpose: BASIC_SCIENCE

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.

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

Primary outcomes:
measure: Change in Brain Response to Food Imagery
timeFrame: 90 minutes
measure: Average Hunger Rating
timeFrame: 90 minutes
Secondary outcomes:
measure: Average Wanting Rating
timeFrame: 90 minutes
measure: Average Liking Rating
timeFrame: 90 minutes
measure: Total Cortisol
timeFrame: Baseline
measure: Total Cortisol
timeFrame: 90 minutes
measure: Free Cortisol
timeFrame: Baseline
measure: Free Cortisol
timeFrame: 90 minutes
measure: Cortisone
timeFrame: Baseline
measure: Cortisone
timeFrame: 90 minutes
measure: Adrenocorticotropic Hormone
timeFrame: Baseline
measure: Adrenocorticotropic Hormone
timeFrame: 90 minutes
measure: Glucose
timeFrame: Baseline
measure: Glucose
timeFrame: 90 minutes
measure: Glucagon
timeFrame: Baseline
measure: Glucagon
timeFrame: 90 minutes
measure: Insulin
timeFrame: Baseline
measure: Insulin
timeFrame: 90 minutes
measure: Leptin
timeFrame: Baseline
measure: Leptin
timeFrame: 90 minutes
measure: Ghrelin
timeFrame: Baseline
measure: Ghrelin
timeFrame: 90 minutes
measure: Neuropeptide Y
timeFrame: Baseline
measure: Neuropeptide Y
timeFrame: 90 minutes
measure: Glucagon-like peptide-1
timeFrame: Baseline
measure: Glucagon-like peptide-1
timeFrame: 90 minutes
Other outcomes:
Locations:
city: New Haven
country: United States
facility: Yale University
state: Connecticut
Study officials:
affiliation: Yale University
name: Robert M Sherwin, MD
role: PRINCIPAL_INVESTIGATOR
References: