Investigating the Central and Peripheral Mechanisms by Which Glucocorticoids Affect Hunger

Yale University

Status and phase: Completed; Phase 1

Conditions: Obesity

Treatments: Other: saline; Drug: hydrocortisone

Study type: Interventional

Funder types: Other; NIH

Identifiers

NCT02722200

1510016716

2R01DK020495-42 (U.S. NIH Grant/Contract)

Details and patient eligibility

About

The purpose of this study is to examine if glucocorticoids will change neural activation in regions of the corticolimbic-striatal system that regulate feeding.

Full 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.

Enrollment: 28 patients

Sex: All

Ages: 18 to 45 years old

Volunteers: Accepts 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

Trial design

Primary purpose: Basic Science

Allocation: Randomized

Interventional model: Crossover Assignment

Masking: Single Blind

---

28 participants in 2 patient groups, including a placebo group

Intravenous glucocorticoids

Experimental group

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.

Treatment:

Drug: hydrocortisone

Intravenous saline

Placebo Comparator group

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.

Treatment:

Other: saline