Effects of Administration of Growth Hormone, Without and With Liraglutide, on AgRP, Energy and Glucose Metabolism in Healthy and GH Deficient Adults

What this Trial Is About

This research aims to understand how growth hormone (GH) affects a brain chemical called AgRP, which is involved in hunger and metabolism, in both healthy adults and adults with GH deficiency aged 18 to 45 years. The study also explores how the diabetes drug liraglutide might influence AgRP levels and investigates the link between GH, AgRP, and insulin resistance. The trial involves a randomized, placebo-controlled, single-blind, crossover design with four treatment arms to compare these effects. Participants will receive four different treatments in random order: GH alone, liraglutide alone, both GH and liraglutide together, and placebo. Each treatment period lasts 21 days, separated by 8-week washout breaks. GH is given as a nightly subcutaneous injection at specific doses depending on health status and gender, while liraglutide is also injected nightly with doses increased weekly to a target level. During each treatment arm, participants undergo a 7-day baseline including testing days, followed by the 21-day treatment with visits on days 2, 7, 14, and 21. Throughout the study, participants will have blood tests and physical measurements to assess insulin resistance, energy use, and body composition. Testing includes glucose tolerance tests, body composition scanning by magnetic resonance, and daily tracking of food intake and activity, except on visit days. The main outcomes measured are changes in AgRP levels during the treatment periods, with safety and metabolic effects also monitored. Total study participation spans multiple treatment and washout phases over several months.

Effects of GH and Lirglutide on AgRP