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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Insulin | Experimental | Regular Insulin, 20 IU twice a day, intranasally, every day for 12 weeks |
|
| Placebo | Placebo Comparator | Normal saline, twice a day, intranasally, every day for 12 weeks |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Insulin | Drug | 20 IU twice a day, intranasally, every day for 12 weeks |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. | Base line, 4, 8 and 12 weeks after intervention |
| Measure | Description | Time Frame |
|---|---|---|
| Changes in Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) Part I, II | Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) part I, II assess the non motor signs of PD; higher score means more severity of the symptoms. | Base line, 4, 8 and 12 weeks after intervention |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Leila Dargahi, PharmD/PhD | Shahid Beheshti University of Medical Sciences | Principal Investigator |
| Mehri Salari, MDFellowship | Shahid Beheshti University of Medical Sciences | Principal Investigator |
| Abolhassan Ahmadiani, PharmD/PhD | Shahid Beheshti University of Medical Sciences | Principal Investigator |
| Neda Valian, PhD | Shahid Beheshti University of Medical Sciences | Study Director |
| Leila Mohaghegh Shalmani, PharmD/PhD | Shahid Beheshti University of Medical Sciences | Study Chair |
| Helia Ashourizadeh, Intern | Shahid Beheshti University of Medical Sciences | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Shahid Beheshti University of Medical Sciences, Shohada-e-Tajrish Hospital | Tehran | Iran |
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| ID | Term |
|---|---|
| D010300 | Parkinson Disease |
| D007333 | Insulin Resistance |
| ID | Term |
|---|---|
| D020734 | Parkinsonian Disorders |
| D001480 | Basal Ganglia Diseases |
| D001927 | Brain Diseases |
| D002493 | Central Nervous System Diseases |
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| ID | Term |
|---|---|
| D007328 | Insulin |
| D000077330 | Saline Solution |
| ID | Term |
|---|---|
| D011384 | Proinsulin |
| D061385 | Insulins |
| D010187 | Pancreatic Hormones |
| D036361 | Peptide Hormones |
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| Normal saline | Drug | twice a day, intranasally, every day for 12 weeks |
|
| Disease severity |
The modified Hoehn and Yahr Scale (HY) is used to assess severity of Parkinson's Disease. The scale ranges from 1 to 5. The lower score indicates better outcome. |
| Base line, 4, 8 and 12 weeks after intervention |
| Risk of Falling | Tinetti Balance Assessment Tool indicates the risk of falling, higher scores is indicative of low risk for falling. | Base line, 4, 8 and 12 weeks after intervention |
| Cognitive score | The Montreal Cognitive Assessment (MoCA) scores range between 0 and 30 with higher scores indicative of better cognitive performance. | Base line, 4, 8 and 12 weeks after intervention |
| Depression score | Beck's Depression Inventory II (BDI-II) scores range between 0 and 63; higher scores is indicative of more severe depression. | Base line, 4, 8 and 12 weeks after intervention |
| Anxiety score | Beck Anxiety Inventory (BAI) scores range between 0 and 63; higher scores is indicative of more anxiety. | Base line, 4, 8 and 12 weeks after intervention |
| Fatigue score | Fatigue Severity Scale (FSS) scores range between 0 and 7; higher scores is indicative of severe fatigue. | Base line, 4, 8 and 12 weeks after intervention |
| D009422 | Nervous System Diseases |
| D009069 | Movement Disorders |
| D000080874 | Synucleinopathies |
| D019636 | Neurodegenerative Diseases |
| D006946 | Hyperinsulinism |
| D044882 | Glucose Metabolism Disorders |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D006728 |
| Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D010455 | Peptides |
| D000602 | Amino Acids, Peptides, and Proteins |
| D000077324 | Crystalloid Solutions |
| D007552 | Isotonic Solutions |
| D012996 | Solutions |
| D004364 | Pharmaceutical Preparations |