Investigating the Central and Peripheral Mechanisms by Which Glucocorticoids Affect Hunger

NCT02722200 | Completed Phase 1 DMC

• 2 other identifiers: 15100167162R01DK020495-42
• Study Type: interventional
• Target: 28
• Locations: 1 country
• Sites: 1

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.

Conditions

Obesity

Keywords

fMRI obesity

Outcome Measures

Primary Outcomes (2)

• 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.

  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.

  90 minutes

Secondary Outcomes (24)

• Average Wanting Rating

  90 minutes

• Average Liking Rating

  90 minutes

• Total Cortisol

  Baseline

• Total Cortisol

  90 minutes

• Free Cortisol

  Baseline

Study Arms (2)

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.

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.

Other: saline

Interventions

hydrocortisone 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 glucocorticoids

saline OTHER

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

Intravenous saline

Eligibility Criteria

• Age: 18 Years - 45 Years
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64)

You may qualify if:

• BMI \< = 26 kg/m2
• Ability to read and write English

You may not qualify if:

• 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

Sponsors & Collaborators

• Yale University: lead
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Yale University

New Haven, Connecticut, 06511, United States

Location

MeSH Terms

Conditions

Obesity

Interventions

Hydrocortisone; Sodium Chloride

Condition Hierarchy (Ancestors)

Overweight; Overnutrition; Nutrition Disorders; Nutritional and Metabolic Diseases; Body Weight; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Pregnenediones; Pregnenes; Pregnanes; Steroids; Fused-Ring Compounds; Polycyclic Compounds; 11-Hydroxycorticosteroids; Hydroxycorticosteroids; Adrenal Cortex Hormones; Hormones; Hormones, Hormone Substitutes, and Hormone Antagonists; 17-Hydroxycorticosteroids; Chlorides; Hydrochloric Acid; Chlorine Compounds; Inorganic Chemicals; Sodium Compounds

Study Officials

• Robert M Sherwin, MD

  Yale University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: PARTICIPANT
• Purpose: BASIC SCIENCE
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 22, 2016
• First Posted: March 29, 2016
• Study Start: May 1, 2016
• Primary Completion: July 19, 2017
• Study Completion: July 19, 2017
• Last Updated: May 25, 2022

Record last verified: 2022-05

Locations

US (1)