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Completed

NCT Number: NCT02722200

Investigating the Central and Peripheral Mechanisms by Which Glucocorticoids Affect Hunger

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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Key information

Conditions

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

Age range

18 year–45 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Yale University

New Haven, Connecticut, 06511, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

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.

Saline

Other

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

Primary outcomes

  1. 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.

  2. 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.

Secondary outcomes

  1. Average Wanting Rating

    Time frame: 90 minutes

    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.

  2. Average Liking Rating

    Time frame: 90 minutes

    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.

  3. Total Cortisol

    Time frame: Baseline

    Total cortisol will be collected from serum at the beginning and end of the procedure.

  4. Total Cortisol

    Time frame: 90 minutes

    Total cortisol will be collected from serum at the beginning and end of the procedure.

  5. Free Cortisol

    Time frame: Baseline

    Free cortisol will be collected from serum at the beginning and end of the procedure.

  6. Free Cortisol

    Time frame: 90 minutes

    Free cortisol will be collected from serum at the beginning and end of the procedure.

  7. Cortisone

    Time frame: Baseline

    Cortisone will be collected from serum at the beginning and end of the procedure.

  8. Cortisone

    Time frame: 90 minutes

    Cortisone will be collected from serum at the beginning and end of the procedure.

  9. Adrenocorticotropic Hormone

    Time frame: Baseline

    Adrenocorticotropic Hormone (ACTH) will be collected from serum at the beginning and end of the procedure.

  10. Adrenocorticotropic Hormone

    Time frame: 90 minutes

    Adrenocorticotropic Hormone (ACTH) will be collected from serum at the beginning and end of the procedure.

  11. Glucose

    Time frame: Baseline

    Glucose will be collected from serum at the beginning and end of the procedure.

  12. Glucose

    Time frame: 90 minutes

    Glucose will be collected from serum at the beginning and end of the procedure.

  13. Glucagon

    Time frame: Baseline

    Glucagon will be collected from serum at the beginning and end of the procedure.

  14. Glucagon

    Time frame: 90 minutes

    Glucagon will be collected from serum at the beginning and end of the procedure.

  15. Insulin

    Time frame: Baseline

    Insulin will be collected from serum at the beginning and end of the procedure.

  16. Insulin

    Time frame: 90 minutes

    Insulin will be collected from serum at the beginning and end of the procedure.

  17. Leptin

    Time frame: Baseline

    Leptin will be collected from serum at the beginning and end of the procedure.

  18. Leptin

    Time frame: 90 minutes

    Leptin will be collected from serum at the beginning and end of the procedure.

  19. Ghrelin

    Time frame: Baseline

    Ghrelin will be collected from serum at the beginning and end of the procedure.

  20. Ghrelin

    Time frame: 90 minutes

    Ghrelin will be collected from serum at the beginning and end of the procedure.

  21. Neuropeptide Y

    Time frame: Baseline

    Neuropeptide Y (NPY) will be collected from serum at the beginning and end of the procedure.

  22. Neuropeptide Y

    Time frame: 90 minutes

    Neuropeptide Y (NPY) will be collected from serum at the beginning and end of the procedure.

  23. Glucagon-like peptide-1

    Time frame: Baseline

    Glucagon-like peptide-1 (GLP-1) will be collected from serum at the beginning and end of the procedure.

  24. Glucagon-like peptide-1

    Time frame: 90 minutes

    Glucagon-like peptide-1 (GLP-1) will be collected from serum at the beginning and end of the procedure.

Sponsors and collaborators

Lead sponsor

Yale University

Other

Collaborators

  • National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

Registry information

Important dates

Study start
2016
Primary completion
2017
Study completion
2017
First posted
Mar 29, 2016
Registry last updated
May 25, 2022

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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