Metabolic Outcomes in Patients With Prolactinomas Under Dopamine Agonist Treatment - A Randomized, Single-Blind Active- Controlled Trial
试验速览
- 阶段
- 4 期
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- 2-hour post-oral glucose tolerance test (OGTT) plasma glucose levels
研究概览
简要总结
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.
详细描述
Prolactinomas are the most common pituitary tumors, leading to hyperprolactinemia, which causes hypogonadism, infertility, and is associated with adverse metabolic effects such as insulin resistance, dyslipidemia, and obesity. Dopamine agonists (DAs), especially cabergoline, are the first-line treatment. They reduce prolactin levels and tumor size effectively. Despite their widespread use, there are no evidence-based guidelines regarding target prolactin levels during DA therapy. Limited evidence suggests that different prolactin levels may have different effects on metabolic health. This trial aims to assess glucose tolerance, insulin sensitivity, and beta-cell function-using OGTT with insulin levels-after 12 months of DA treatment, to target treatment options.
In Switzerland, cabergoline is the preferred DAs for treating hyperprolactinemia.
Cabergoline 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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Investigator, Outcomes Assessor)
盲法说明
Outcome assessors (e.g., study nurses and study physicians) will all remain blinded to the treatment allocation.
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- 未提供
排除标准
- •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)
研究组 & 干预措施
Experimental intervention arm (Cabergoline)
The experimental intervention arm aims to treat patients (with hyperprolactinemia) with Cabergoline (Dopamine Agonist) by targeting the suppression of prolactin levels (below the normal plasma prolactin range).
干预措施: Cabergoline (Dopamine Agonist) (Drug)
Control intervention arm (Cabergoline)
The control intervention arm aims to treat patients (with hyperprolactinemia ) with Cabergoline (Dopamine Agonist) by targeting the normalisation of prolactin levels (within the normal plasma prolactin range).
干预措施: Cabergoline (Dopamine Agonist) (Drug)
结局指标
主要结局
2-hour post-oral glucose tolerance test (OGTT) plasma glucose levels
时间窗: assessed at 12 months after randomisation
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.
次要结局
- Change in Insulin sensitivity by MATSUDA Index(measured at time points (0, 30, 60, 90, and 120 minutes) during the OGTT)
- Change in Insulin Sensitivity Index (ISI)(measured at time points (0, 30, 60, 90, and 120 minutes) during the OGTT)
- Change in Quantitative Insulin Sensitivity Check Index (QUICKI)(measured at time points Screening, Month 6, Month 12, Month 24)
- Change in Glycated Haemoglobin (HbA1c)(measured at time points Screening, Month 3, Month 6, Month 12)
- Change in Fasting glucose (mmol/L)(measured at time points Screening, Month 3, Month 6, Month 12)
- Change in Fasting insulin (µU/mL)(measured at time points Screening, Month 3, Month 6, Month 12)
- Change in C-peptide (nmol/l)(measured at time points Screening, Month 3, Month 6, Month 12)
- Change in Disposition Index (DI)(measured at time points Screening, Month 3, Month 6, Month 12)
- Change in plasma prolactin levels (ng/mL)(measured at time points Screening, Month 3, Month 6, Month 12)