Insulin Resistance in Primary Hyperparathyroidism, a Non-classical Manifestation
试验速览
- 阶段
- 不适用
- 状态
- 撤回
- 发起方
- 试验地点
- 2
- 主要终点
- quality of life - self estimation protocol
研究概览
简要总结
The aims of this study is to analyse if insulin resistance in primary hyperparathyroidism (pHPT) is normalised after parathyroid adenomectomy and if glucose tolerance test may be useful as a diagnostic tool by predicting potential improvement of insulin sensitivity after biochemical cure of pHPT.
详细描述
To be conducted at the Karolinska University Hospital, Stockholm. Patients with fb-glucos >6.1 and HbA1c without medical treatment will be included after informed consent and randomised to parathyroidectomy (PTX) within three months or not. The groups will be examined 4 ±4 weeks before and 12±2 weeks after PTX, similar for the control group. The number of participants will be estimated by power calculations based on a pilot study including 20 patients.
The test protocol includes glucose load with control of glucose and insulin, (0, 30, 60 and 120 min) together with measurement of markers of oxidative stress and inflammation.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Basic Science
- 盲法
- None
入排标准
- 年龄范围
- 50 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •primary hyperparathyroidism and fb-glukos>6,1 and/or HbA1c > 39 mmol/mol
排除标准
- •Treatment with insulin, sulfonylurea or metformin
结局指标
主要结局
quality of life - self estimation protocol
时间窗: 3 months
EORTC QLQ-C30
glucose tolerance test with estimation of insulin resistance
时间窗: 3 months
Homa IR
次要结局
- psychological wellbeing(3 months)
- anxiety, depression(6 months)
- cognition(6 months)
研究者
Inga-Lena Nilsson
MD, PhD, consultant surgeon
Karolinska University Hospital