Clinical Study to Evaluate the Possible Efficacy of Metformin in Patients With Parkinson's Disease

Study Overview
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Brief Summary
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Parkinson's disease (PD) is one of the most common neurodegenerative diseases characterized by the progressive loss of dopaminergic (DA) neurons in the substantia nigra compacta (SNc) and aggregation of Lewy bodies in neurons. Although aging, oxidative damage and neuroinflammation have been recognized to play crucial roles in the pathogenesis of PD, the precise etiology remains obscure. Emerging evidence suggests PD is a systemic metabolic disease, and metabolic abnormality correlates with functional alternations in PD

Official Title
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Clinical Study to Evaluate the Possible Efficacy of Metformin in Patients With Parkinson's Disease

Conditions
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Parkinson Disease

Intervention / Treatment
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* Drug: levodopa-carbidopa
* Drug: Metformin


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Age ≥ 18 years Both males and females will be included Negative pregnancy test and effective contraception. Diagnosed Parkinson's disease patient taking Levodopa Exclusion Criteria: Secondary causes of Parkinsonism Diabetic patients Patients taking anti-inflammatory drugs Atypical parkinsonian syndromes Prior stereotaxic surgery for Parkinson's disease Pregnancy and lactation Suffering from active malignancy Addiction to alcohol and/or drugs Known allergy to the studied medications

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Control Group<br>Control group ( Levo-dopa group, n =30 ) who will receive levodopa/carbidopa (50/250 mg) three times daily for 3 months | Drug: levodopa-carbidopa<br>* levodopa-carbidopa is the standard therapy used in Parkinson's disease<br>|
| Active Comparator: Metformin group<br>Patients will receive levodopa/carbidopa (50/250 mg) three times daily plus metformin 500 mg two times daily for 3 months | Drug: levodopa-carbidopa<br>* levodopa-carbidopa is the standard therapy used in Parkinson's disease<br>Drug: Metformin<br>* Metformin, a biguanide family member commonly used in treatment for type 2 diabetes, appears to increase liver and peripheral tissue sensitivity to insulin as well as reduce hepatic glucose production<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| • The primary endpoint is the change in The Unified Parkinson's Disease Rating Scale (UPDRS) | • The primary endpoint is the change in the Unified Parkinson's Disease Rating Scale (UPDRS | 3 months | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| The secondary endpoint is estimated by changes in serum biomarkers. | The secondary endpoint is estimated by changes in serum biomarkers such as brain derived neurotropic factor | 3 months |