Actively Recruiting
Metabolic Outcomes in Patients With Prolactinomas Under Dopamine Agonist Treatment - A Randomized, Single-Blind Active-Controlled Trial
Led by University Hospital, Basel, Switzerland · Updated on 2025-09-23
60
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
AI-Summary
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.
CONDITIONS
Brief Title
Metabolic Outcomes in Patients With Prolactinomas Under Dopamine Agonist Treatment
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosed adult patients (at least 18 years of age) with prolactinoma-induced hyperprolactinemia as defined by prolactin levels at least twice the local laboratory maximum and radiographic criteria
- Diagnosed adult patients (at least 18 years of age) with prolactinoma-induced hyperprolactinemia based on current guidelines
- Patients treated with cabergoline as dopamine agonist therapy with prolactin levels within normal range
You will not qualify if you...
- Alternative explanation for hyperprolactinemia
- Active substance use disorder within the last six months
- Current or previous psychotic disorder
- Pregnancy or breastfeeding within the last 8 weeks
- Severe hepatic insufficiency or cholestasis (Child Pugh C, AST/ALT > 3 times upper limit of normal, or total bilirubin > 2 times upper limit of normal)
- Severe renal impairment (eGFR less than 30 ml/min)
- History of pulmonary, pericardial, or retroperitoneal fibrotic disorders
- Concomitant treatment with strong or moderate CYP3A4 inhibitors
- Local complications on imaging or clinical symptoms requiring surgical intervention or patient preference for surgery
- Gastrointestinal disease or surgery such as chronic active inflammatory bowel disease, active ulcers, or prior gastrointestinal surgery
- Incapacity to give informed consent due to cognitive or legal reasons
AI-Screening
AI-Powered Screening
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Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 12 months
Participants receive dopamine agonist treatment with cabergoline to target specific prolactin levels based on their assigned intervention arm.
Regular visits during the 12 months of treatment for dosing adjustments and assessments including oral glucose tolerance tests and blood draws
Trial Site Locations
Total: 1 location
1
University Hospital Basel, Dept. of Endocrinology, Metabolism & Diabetes
Basel, Switzerland, 4031
Actively Recruiting
Research Team
C
Cihan Atila, Dr.
How is the study designed?
Study Type
INTERVENTIONAL
Masking
DOUBLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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