Investigating the effects of a glucagon-like peptide-1 receptor agonist on adrenal function in healthy males
Glucagon-like Peptide-1 Receptor Agnoists for the Assessment of Adrenal Function - the PIANO Study
This study is testing how a single dose of a diabetes drug called semaglutide affects stress hormones in healthy men aged 18-60.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 23 (estimated) |
| Ages | 18 Years to 60 Years |
| Sex | Male |
| Sponsor | University Hospital, Basel, Switzerland Academic / other |
| Locations | 1 site (Basel) |
| Trial ID | NCT06608433 on ClinicalTrials.gov |
What this trial studies
This study examines how a single dose of the glucagon-like peptide-1 receptor agonist semaglutide affects the hypothalamo-pituitary-adrenal axis and cortisol levels in healthy male volunteers. Participants will receive either semaglutide or a placebo to assess the drug's impact on stress hormones. The study focuses on understanding adrenal function and its regulation in response to this medication. Healthy males aged 18-60 with a specific BMI range will be recruited for this investigation.
Who should consider this trial
Good fit: Ideal candidates for this study are healthy male volunteers aged 18-60 years with a BMI between 18.5 and 30 kg/m2.
Not a fit: Patients with a history of glucocorticoid or GLP-1 receptor agonist intake in the last 8 weeks or those with known allergies to GLP-1 receptor agonists may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could enhance our understanding of adrenal function and improve treatment strategies for conditions related to cortisol deficiency.
How similar studies have performed: While the specific approach of using semaglutide in this context may be novel, similar studies have explored the effects of glucagon-like peptide-1 receptor agonists on various physiological processes.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria: * Healthy male volunteers aged 18-60 years * BMI 18.5-30 kg/m2 * No regular medication Exclusion Criteria: * participation in a trial with investigational drugs within 30 days * vigorous physical exercise within 24 hours before the study participation * alcohol intake within 24 hours before the study participation * a history of intake of glucocorticoids or GLP-1 RA within the last 8 weeks. * Known allergy towards GLP-1 RA
Where this trial is running
Basel
- University Hospital Basel — Basel, Switzerland (Recruiting)
Study contacts
- Study coordinator: Sandrine Urwyler, PD Dr. med.
- Email: sandrine.urwyler@usb.ch
- Phone: +41 61 265 50 78
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.