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临床试验/ACTRN12624001010583
ACTRN12624001010583招募中Unknown

Acute effects of dopaminergic therapy with levodopa/carbidopa on the gastric emptying, blood pressure and superior mesenteric artery blood flow responses to oral glucose in patients with mild to moderate Parkinson’s disease.

Professor Karen Jones, The University of Adelaide0 个研究点目标入组 20 人开始时间: 2024年8月20日最近更新:
适应症

试验速览

阶段
Unknown
状态
招募中
发起方
入组人数
20

研究概览

简要总结

暂无简介。

研究设计

研究类型
Interventional
分配方式
Randomised controlled trial
主要目的
Treatment
盲法
Blinded (masking used)

入排标准

年龄范围
50 Years 至 80 Years(—)
性别
All

入选标准

  • Patients currently taking short-acting levodopa/carbidopa
  • Body Mass Index (BMI) 19 - 30 kg/m²
  • A diagnosis of idiopathic PD according to the UK brain bank criteria of mild to moderate PD (Hoehn and Yahr Staging <2.5)

排除标准

  • History of diabetes mellitus (or fasting plasma glucose >7.0 mmol/L or HbA1C > or =6.5%), severe respiratory, cardiovascular, haematologic, hepatic and/or renal disease (creatinine clearance <50 mL/min), chronic alcohol abuse or epilepsy or if iron stores, or liver function tests are two times greater than the upper limit of the following normal ranges:
  • Alanine aminotransferase (ALT)< 55 U/L
  • Alkaline phosphatase (ALP)30 - 110 U/L
  • Aspartate transaminase (AST)< 45 U/L
  • Total bilirubin2 - 24 µmol/L
  • Haemoglobin115 – 165 g/L (Females)
  • 130 – 180 g/L (Males)
  • Ferritin15 – 200 µg/L (Females)
  • 30 – 300 µg/L (Males)
  • Medication that influence BP or GI function
  • Patients taking long-acting levodopa preparations
  • History of GI disease (unrelated to PD), including known gastroparesis, significant upper GI symptoms and gastric surgery
  • Smoking >10 cigarettes/day
  • Alcohol consumption > 20 g/day
  • Blood donation in the previous 12 weeks
  • Pregnancy or breastfeeding
  • Inability to withdraw from the morning dose of anti-Parkinsonian medication to allow a washout.
  • Contraindications to levodopa/carbidopa, including current treatment with MAO inhibitor, known hypersensitivity, narrow-angle glaucoma, melanoma and suspicious undiagnosed skin lesions.

研究者

发起方
Professor Karen Jones, The University of Adelaide

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