CompletedEarly Phase 1

Acute Consequences Of Food-induced Glucocorticoid Secretion In Healthy Individuals

Switzerland20 participantsStarted 2022-02-08

Plain-language 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.

Who can participate

Age range18 Years – 40 Years

SexMALE

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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Insulin sensitivity

Timeframe: Two 8-day intervention periods

Trial details

NCT IDNCT05167084

SponsorEleonora Seelig

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2023-06-08