Cabergoline treatment targets and glucose metabolism in people with prolactinomas
Metabolic Outcomes in Patients With Prolactinomas Under Dopamine Agonist Treatment - A Randomized, Single-Blind Active- Controlled Trial
This trial will test whether different cabergoline treatment targets change blood sugar control in adults with prolactinomas.
Quick facts
| Phase | Phase 4 |
|---|---|
| Study type | Interventional |
| Enrollment | 60 (estimated) |
| Ages | 18 Years and up |
| Sex | All |
| Sponsor | University Hospital, Basel, Switzerland Academic / other |
| Locations | 1 site (Basel) |
| Trial ID | NCT07045935 on ClinicalTrials.gov |
What this trial studies
This is a randomized, active-controlled, parallel-arm, single-blind Phase 4 trial comparing two established dopamine agonist (cabergoline) treatment strategies over 12 months. Participants will undergo oral glucose tolerance testing with insulin measurements to quantify glucose tolerance, insulin sensitivity, and beta-cell function. The trial compares targeting different prolactin levels during cabergoline therapy to see if metabolic outcomes differ. All treatment and testing are carried out at the University Hospital Basel with cabergoline given according to guideline-based dosing.
Who should consider this trial
Good fit: Adults (≥18 years) with prolactinoma-induced hyperprolactinemia who are eligible for cabergoline therapy according to current imaging and laboratory criteria are ideal candidates.
Not a fit: People with alternative causes of high prolactin, recent pregnancy or breastfeeding, active substance use or psychotic disorders, severe liver or kidney impairment, or who cannot attend visits in Basel are unlikely to benefit from participation.
Why it matters
Potential benefit: If successful, results could clarify which cabergoline treatment target best preserves or improves glucose metabolism for people with prolactinomas.
How similar studies have performed: Dopamine agonists like cabergoline are well established for lowering prolactin and shrinking tumors, but randomized comparisons focusing on metabolic outcomes by different prolactin targets are limited and this approach is relatively novel.
Eligibility criteria
Show full inclusion / exclusion criteria
Inclusion Criteria (treatment-naïve patients): * Diagnosed adult patients (at least 18 years of age) with prolactinoma-induced hyperprolactinemia, defined as a prolactin level ≥ two times the local laboratory maximum and radiographic criteria, based on current guidelines. Inclusion Criteria (treatment-naïve patients): * Diagnosed adult patients (at least 18 years of age) with prolactinoma-induced hyperprolactinaemia based on current guidelines. * Patients treated with cabergoline as DA therapy and prolactin levels within the normal range Exclusion Criteria: * alternative explanation for hyperprolactinaemia * 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 or * AST/ ALT \> 3 x the upper limit of normal ULN or * Cholestasis (total bilirubin \> 2x ULN) * Severe renal impairment (eGFR \< 30 ml/min) * History of pulmonary, pericardial, and/or retroperitoneal fibrotic disorders * Concomitant treatment with strong or moderate CYP3A4 inhibitors * Local complications on morphological imaging, related to signs or clinical symptoms which make surgical intervention necessary or a clear patient's preference for surgical treatment * Gastrointestinal disease or previous surgery: chronic active inflammatory bowel disease, active gastrointestinal ulcer disease, or surgery on the gastrointestinal tract (e.g. sleeve stomach, gastric band) * Patient incapable of giving informed consent due to cognitive impairment or other reasons (e.g., legal incapacity)
Where this trial is running
Basel
- University Hospital Basel, Dept. of Endocrinology, Metabolism & Diabetes — Basel, Switzerland (Recruiting)
Study contacts
- Principal investigator: Cihan Atila, Dr. — University Hospital Basel, Dept. of Endocrinology, Metabolism & Diabetes
- Study coordinator: Cihan Atila, Dr.
- Email: cihan.atila@usb.ch
- Phone: +41 61 328 4579
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.