Parkinsons Disease (PD)
Conditions
Keywords
Parkinson's disease, Neuroinflamation, Metformin, Alpha synuclein, MDA levels, MDS-UPDRS
Brief summary
This study will evaluate whether metformin when it will be given to patients with Parkinson's disease along with standard therapy (levodopa carbidopa) will improve motor symptoms and decreases levels of alpha synuclein and MDA in patients with PD as compare to PD patients receiving only standard therapy (levodopa carbidopa)
Interventions
DRUGMetformin 500mg
Metformin will be given to the group B along with the standard treatment
Sponsors
Jinnah Medical & Dental College
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
SUPPORTIVE_CARE
Masking
NONE
Masking description
Masking Description
Intervention model description
Model Description
Eligibility
Sex/Gender
ALL
Age
50 Years to 70 Years
Healthy volunteers
No
Inclusion criteria
: Male and female patients diagnosed with primary PD age 50-70 years receiving levodopa + carbidopa. Diagnosis will be made in accordance with movement disorder society clinical diagnostic criteria for Parkinson's disease
Exclusion criteria
Secondary Parkinsonism co-morbid (such as Diabetes mellitus, Cardio-vascular diseases, Senile tremors, Wilson's disease, Cancers etc.) Pregnant and lactating mothers Sensitivity to metformin Lactic acidosis History of alcohol use
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| MDS-UPDRS | 12weeks | Change in the Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) score from baseline to 12 weeks to assess changes in Parkinson disease symptoms. The MDS-UPDRS (Movement Disorder Society-Unified Parkinson's Disease Rating Scale) is the standard scale used to assess the severity and progression of Parkinson's disease (PD) and response to treatment. It has 4 parts. Part I Non-motor experiences of daily living 52 Part II Motor experiences of daily living 52 Part III Motor examination performed by clinician 132 Part IV Motor complications of treatment, e.g., dyskinesia and fluctuations 24 Total score: 260 Each item is generally scored: 0 = Normal / no problem 1. = Slight 2. = Mild 3. = Moderate 4. = Severe Higher scores represents greater severity of Parkinson's disease. |
| MDA levels | 12 weeks | Change in malondialdehyde (MDA) levels from baseline to 12 weeks to asses changes in oxidative stress |
| Alpha Synuclein levels | 12 weeks | Change in serum alpha-synuclein concentration from baseline to 12 weeks |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Safety profile of metformin | From baseline to Week 12 | Safety profile of the interventional drug (metformin) will be assed in Group B (intervention group) 30 patients. blood samples will be taken for blood (CBC) to check hemoglobin levels |
| Safety Profile of Metformin | From baseline to week 12 | Safety profile of the interventional drug (metformin) will be assed in Group B (intervention group) 30 patients. blood samples will be taken to assess the Renal side effects of drug by measuring Urea, creatinine, GFR |
Contacts
CONTACTSyeda Midhat Zaidi, MBBS
CONTACTNasim Karim, MBBS, MPhil, PhD, Post-doc
Outcome results
None listed