Acute Consequences Of Food-induced Glucocorticoid Secretion In Healthy Individuals

• Status: Not yet recruiting
• Trial end date: 2022-09-01
• Target enrollment: 0
• Participant gender: Male

Summary

In a randomized, cross-over study, 20 healthy volunteers will receive a block and replace therapy that mimics physiological GC rhythm (metyrapone plus hydrocortisone) or placebo. Participants will undergo two identical overfeeding periods with each treatment. With the block and replace therapy, food-induced GC peak will be suppressed. Metabolic and autonomic parameters will be compared to reveal, whether GCs mediate the physiological adaptions to excessive food intake.

Understanding acute effects of GCs upon food intake is critical, since repetitive disruptions of GC secretion may become harmful in chronic conditions.

• Phase: Early Phase 1
• Accepts Healthy Volunteers?: Accepts Healthy Volunteers

Details

• Lead Sponsor: Eleonora Seelig
• Treatments: Hydrocortisone; Metyrapone

Criteria

Inclusion Criteria:

• BMI 18.5 - 25 kg/m2

Exclusion Criteria:

• Previous medical history for any chronic condition in the last three months, active disease or abnormal physical examination as verified by a qualified physician.

• Casual smoking (>6 cigarettes per day)

• Frequent, heavy alcohol consumption (>30g/day)

• Frequent, heavy caffeine consumption (>4 caffeinated drinks/day)

• Regular physical exercise (>4hrs per week)

• Shift workers

• Participation in an investigational drug trail within the past two months

• Intake of any drugs (prescribed, over the counter or recreational) including topical steroids and inhalers, within 48 hours of the study initiation

• Known allergy to metyrapone

• Inability or unwillingness to provide informed consent