Metabolic Outcomes in Patients With Prolactinomas Under Dopamine Agonist Treatment
ConditionProlactinoma
Trial statusRecruiting
Trial phasePhase 4
Trial typeInterventional
Biological sexAll
Age18+
SponsorUniversity Hospital, Basel, Switzerland
About this trial
This randomized, active-controlled, parallel-arm, single-blind trial is to compare the effects of Dopamine agonists (DA) therapy targeting different established treatment strategies on glucose metabolism assessed by an oral glucose tolerance test.
Eligibility criteria
This trial does not accept healthy volunteersQualifiers
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.
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
Disqualifiers
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
Trial design
Design model
Parallel
Treatments tested in this trial
Cabergoline (Dopamine Agonist)
DrugCabergoline is available in tablet form, with doses of 0.5 mg per tablet. The standard dosing for hyperprolactinemia typically starts at 0.25 mg to 0.5 mg per week, which can be gradually increased based on the patient's response, with a usual range of 0.25 mg to 2 mg per week. The dose required to achieve the target prolactin levels (pre- defined for each intervention arm) may vary between patients, so a fixed dose is not specified. This allows for individualized treatment based on each patient's response.
Treatment groups
60 Participants
are divided into 2 treatment groupsGroup A: Experimental intervention arm (Cabergoline)Active comparator 1 intervention
Group B: Control intervention arm (Cabergoline)Active comparator 1 intervention
Trial outcomes
Primary outcomes
1
2-hour post-oral glucose tolerance test (OGTT) plasma glucose levels
The OGTT is a test used to assess the ability to process glucose. It involves fasting overnight and then drinking a solution containing a measured amount of glucose (75g). Blood Samples are taken at 120 min after glucose intake.
Time frame
assessed at 12 months after randomisationSecondary outcomes
1
Change in Insulin sensitivity by MATSUDA Index
The Matsuda Index is a measure used to assess insulin sensitivity from the data obtained during an OGTT. The Index is derived from OGTT data and reflects whole-body insulin sensitivity by incorporating both fasting and postprandial glucose and insulin levels. The formula uses (1) fasting glucose and insulin before the glucose load and (2) mean glucose and mean insulin.
Time frame
measured at time points (0, 30, 60, 90, and 120 minutes) during the OGTT2
Change in Insulin Sensitivity Index (ISI)
ISI is an OGTT-based measure that quantifies insulin sensitivity using fasting and post-load insulin and glucose values. It is similar to the Matsuda Index but has variations depending on specific formulas. Higher ISI values reflect better insulin action.
Time frame
measured at time points (0, 30, 60, 90, and 120 minutes) during the OGTT3
Change in Quantitative Insulin Sensitivity Check Index (QUICKI)
QUICKI is a simple, fasting- based index to estimate insulin sensitivity, calculated as 1 / (log(Fasting Insulin) + log(Fasting Glucose)). Higher values indicate greater insulin sensitivity.
Time frame
measured at time points Screening, Month 6, Month 12, Month 244
Change in Glycated Haemoglobin (HbA1c)
HbA1c reflects average blood glucose levels over the past 2-3 months by measuring glucose-bound haemoglobin. It is used for diagnosing and monitoring diabetes, with values ≥6.5% indicating diabetes.
Time frame
measured at time points Screening, Month 3, Month 6, Month 12Sponsors and contacts
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Source ClinicalTrials.gov