The Effect of Intranasal Insulin on Motor and Non-motor Symptoms in Parkinson's Disease Patients

dr.dargahi28 enrolled

Overview

This study will evaluate the effect of intranasal insulin on motor and non-motor symptoms of patients with Parkinson's disease over a 12-week period.

This study is a single-center, parallel and double-blind study. Patients with Parkinson's disease referred to Movement Clinic of Shohada-e-Tajrish Hospital will randomly receive intranasal placebo or insulin, every day, twice a day for 12 weeks. Motor and non-motor symptoms will be evaluated in four time points; baseline, 4, 8 and 12 weeks after treatments. Primary outcome is motor symptoms (MDS-UPDRS; part III, IV), and secondary outcomes are motor (gait balance) and non-motor (MDS-UPDRS part I, II, cognition, depression, anxiety and fatigue) symptoms. Patients, researchers (physicians, outcome assessors) and data analysts are blinded.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

Conditions

Parkinson Disease

Interventions

InsulinDRUG

20 IU twice a day, intranasally, every day for 12 weeks

Normal salineDRUG

twice a day, intranasally, every day for 12 weeks

Eligibility

Sex: ALLMin age: 17 Years

Medical Language ↔ Plain English

Inclusion Criteria: * Man and woman over 17 years old * Patient with Parkinson's disease according to UK Parkinson's Disease Society Brain Bank Diagnostic Criteria * Provide written informed consent to participate in the study. * Understand that they may withdraw their consent at any time. Exclusion Criteria: * Pregnant and lactating women * Patients with diabetes and taking anti-hyperglycemic drugs * Patients with other neurodegenerative diseases like multiple system atrophy, Huntington's, Wilson's disease, Alzheimer's, Amyotrophic lateral sclerosis (ALS), progressive supranuclear palsy, etc. * Patients who cannot walk for more than one minute without help * A history of allergic reaction to insulin * The presence of inflammation of nasal cavity that may prevents absorption of insulin

Locations (1)

Shahid Beheshti University of Medical Sciences, Shohada-e-Tajrish Hospital

Tehran, Iran

Outcomes

Primary Outcomes

Changes in Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part III, IV

Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) part III, IV assess the motor signs of Parkinson's Disease; higher score means more severity of the motor symptoms.