Comparing Cabergoline Treatment Strategies for Metabolic Effects in Adults with Prolactinomas

What this Trial Is About

Prolactinomas are common pituitary tumors that cause high prolactin levels leading to hormone imbalances and metabolic issues such as insulin resistance, abnormal blood fats, and obesity. This trial compares different dopamine agonist treatment strategies, specifically cabergoline dosing targets, to understand their impact on glucose metabolism in patients with prolactinomas. The study is a randomized, single-blind, active-controlled trial assessing these effects over 12 months. Participants are treated with cabergoline tablets, starting at 0.25 mg to 0.5 mg per week, with doses adjusted individually to reach either suppressed prolactin levels below normal or normalized prolactin levels within the normal range. The trial has two groups one aiming to reduce prolactin below normal, and the other aiming for normal prolactin levels. Dosing is flexible based on patient response, and treatment continues for 12 months. During the study, participants undergo an oral glucose tolerance test OGTT at 12 months to measure plasma glucose levels, insulin sensitivity, and beta-cell function. Various metabolic parameters, including glycated hemoglobin, fasting glucose and insulin, C-peptide, and prolactin levels, are monitored at screening and multiple time points throughout the year. The primary focus is on glucose metabolism changes after one year of dopamine agonist treatment, with safety and metabolic effects closely followed by the research team.

Metabolic Outcomes in Patients With Prolactinomas Under Dopamine Agonist Treatment