RecruitingPhase 4ACTRN12620000627954

The effect of a GLP-1 agonist in patients with a dual diagnosis of Parkinson's Disease and Type 2 Diabetes Mellitus

Sponsor

St Vincent's Health Network

Enrollment

12 participants

Start Date

Jun 1, 2020

Study Type

Interventional

Conditions

Type 2 Diabetes Mellitus Parkinson's Disease

Summary

Parkinson’s Disease (PD) is a progressive neurodegenerative condition that is associated with significant morbidity and loss of independence. Currently, there are few avenues of treatment and even the most potent dopamine-replacement therapies, whilst alleviating some cardinal symptoms, do not alter the underlying disease process or interfere with the progression of the disease. This study will address the potential use of GLP-1 agonists, approved for the use of Type 2 Diabetes, as a therapeutic option. Pre-clinical and human studies have been released that show: (1) The shared mechanism of Parkinson's Disease and Type 2 Diabetes (2) The neuro-protective effects of GLP-1 agonists in Parkinson's Disease However, this study will be the first to analyse this effect in patients with a dual diagnosis of Type 2 Diabetes and Parkinson's Disease. A positive outcome from this study has the clinical potential for becoming the basis for a larger scale randomised-control trial and adjusting the existing diabetes management of this patient population. Both disease processes could be targeted with a medication that is already PBS-listed and the standard of care for one.

Eligibility

Sex: Both males and femalesMin Age: 45 Yearss

Plain Language Summary

Simplified for easier understanding

Parkinson's disease is a progressive brain condition that causes tremors, stiffness, and difficulty with movement, and for which there is currently no treatment that can slow or stop the underlying damage. Interestingly, research has found that Parkinson's disease and type 2 diabetes share similar biological mechanisms, and a class of diabetes medications called GLP-1 agonists (such as exenatide, used to lower blood sugar) have shown promise in protecting brain cells in animal studies and small human trials. This study will be the first to specifically test whether treating type 2 diabetes with a GLP-1 agonist medication also leads to improvements in Parkinson's disease symptoms in patients who have both conditions. This is a clever opportunity to use an already-approved, government-subsidised diabetes medication to potentially treat two conditions at once. You may be eligible if you are 45 or older, have been diagnosed with both Parkinson's disease (meeting UK Brain Bank criteria) and type 2 diabetes, have an HbA1c of 7% or above, and are not currently using a GLP-1 agonist medication or insulin. You must be able to give informed consent and have sufficient cognitive function (MMSE score of 24 or above).

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

The study intervention is administration of GLP1-agonist Exenatide extended release (Bydureon) 2mg subcutaneously weekly in patients with a dual diagnosis of Parkinson's Disease and Type 2 Diabetes Mellitus. The study intervention will be administered for a total of 12 months. Patients will be monitored for their Parkinson's symptoms and glycemic control at baseline, 3 months, 6 months and 12 months.