Does levodopa/carbidopa, a common Parkinson's Disease drug, affect stomach emptying, blood pressure and heart rate?

Not Applicable

Recruiting

• Conditions: Parkinson's disease; Postprandial hypotension; Delayed gastric emptying; Oral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon; Cardiovascular - Diseases of the vasculature and circulation including the lymphatic system; Metabolic and Endocrine - Other metabolic disorders; Neurological - Parkinson's disease; Cardiovascular - Other cardiovascular diseases

• Registration Number: ACTRN12624001010583
• Lead Sponsor: Professor Karen Jones, The University of Adelaide

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Study Start: 2024-08-20
• Last Update Posted: 26 August 2024

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

•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)

Exclusion Criteria

•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.

Study & Design

• Study Type: Interventional
• Study Design: Not specified