RecruitingACTRN12624001010583

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

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.


Sponsor

Professor Karen Jones, The University of Adelaide

Enrollment

20 participants

Start Date

Sep 20, 2018

Study Type

Interventional

Conditions

Summary

In this study, we are interested in looking at the acute effects of the anti-Parkinson drug, levodopa/carbidopa (Sinemet®) on the rate of stomach emptying, blood pressure and abdominal blood flow after a sugary drink, and the relationship between the rate of stomach emptying and the rise in levodopa levels. The primary hypotheses underlying the study are that (i) a therapeutic dose of levodopa (200mg) / carbidopa (50mg) will slow gastric emptying in patients with mild to moderate Parkinson’s disease and (ii) this slowing of gastric emptying will be associated with an attenuation in the fall in blood pressure, and the rise in superior mesenteric artery (SMA) blood flow, after oral glucose.


Eligibility

Sex: Both males and femalesMin Age: 50 YearssMax Age: 80 Yearss

Plain Language Summary

Simplified for easier understanding

Levodopa/carbidopa (Sinemet) is the most commonly used medication for Parkinson's disease, but the way it is absorbed into the body is complex and varies from person to person. One factor that affects this is how quickly the stomach empties its contents into the small intestine — a process called gastric emptying — which directly influences how fast the drug is absorbed and how effective it is. This study is looking at how a standard therapeutic dose of levodopa/carbidopa affects gastric emptying speed, blood pressure, and blood flow in the abdomen after drinking a glucose solution. Researchers also want to understand the relationship between gastric emptying rate and the rise of levodopa in the blood, and whether the medication helps protect against the post-meal drop in blood pressure that is common in people with Parkinson's disease. This is a carefully controlled study comparing the effects before and after taking the medication. You may be eligible if you are aged 50 to 80, have a confirmed diagnosis of mild to moderate Parkinson's disease, and are currently taking short-acting levodopa/carbidopa. People with diabetes, severe heart, liver, or kidney disease, stomach or GI conditions unrelated to Parkinson's, or who are taking medications that affect blood pressure or gut function are not eligible. The study is run by the University of Adelaide.

This summary was AI-generated to explain the trial in plain language. It is not medical advice. Always discuss eligibility with your doctor before enrolling in a clinical trial.

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Interventions

Patients will attend on two separate occasions (after fasting from solids for 14 h and liquids for 12 h) at least five days apart. At t= -60 minutes, the patient will then be given either (1) an

Patients will attend on two separate occasions (after fasting from solids for 14 h and liquids for 12 h) at least five days apart. At t= -60 minutes, the patient will then be given either (1) an oral dose of levodopa (200mg)/carbidopa (50mg) (tablet) or (2) matching placebo. At t = -3 min, the patient will consume a drink comprising 75 g glucose labelled with 20 MBq 99mTc-calcium phytate, made up to 300ml water. The end of drink consumption will be recorded as t = 0 min Patients will then undergo concurrent measurements of gastrointestinal (GI) symptoms (questionnaire), gastric emptying (scintigraphy) , blood pressure, heart rate (Dinamap) and superior mesenteric artery blood flow (Doppler ultrasound), blood glucose , serum insulin , and plasma levodopa (L-DOPA) concentrations for a period of 3 hours i.e. t= 0-180 min, following the drink.


Locations(1)

The Royal Adelaide Hospital - Adelaide

SA, Australia

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ACTRN12624001010583