None listed
Conditions
Brief 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.
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.
Sponsors
St Vincent's Health Network
Study design
Allocation
Non-randomised trial
Intervention model
Parallel
Primary purpose
Treatment
Masking
Blinded (masking used) (Investigator, Outcomes Assessor)
Eligibility
Sex/Gender
All
Age
45 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Diagnosis of Parkinson’s disease meeting UK Brain Bank Criteria 2. Diagnosis of Type 2 Diabetes not receiving GLP-1 agonist therapy 3. HbA1c greater than or equal to 7 % 4. Willingness to give written informed consent and willingness to participate to and comply with the study. 5. Patients with cognitive impairment sufficient to impair capacity to provide informed consent are excluded from the study (MMSE<24) 6. Age >45 years
Exclusion criteria
1. Patient incapable of providing informed consent 2. Patients receiving insulin treatment for type 2 diabetes 3. Contraindications to Extended release Exentatide (Bydureon) therapy including: pregnancy, Multiple Endocrine Neoplasia Type 2, Medullary Carcinoma of the thyroid, active Crohn’s disease or Ulcerative colitis, gastritis or severe gastroparesis, pancreatitis and chronic renal impairment with eGFR<30 ml/min
Outcome results
None listed