Protocol summary
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Study aim
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1. Evaluating the effect of intranasal insulin on motor symptoms of Parkinson’s disease
2. Evaluating the effect of intranasal insulin on non-motor symptoms of Parkinson’s disease
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Design
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This study is a single-center, parallel and double-blind study. Patients, researchers (physicians, outcome assessors) and data analysts are blinded. Patients with Parkinson's disease referred to Motor Movement Clinic of Shohadaye Tajrish Hospital are randomly divided into control and treatment groups.
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Settings and conduct
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Patients with Parkinson's disease referred to Motor Movement Clinic of Shohadaye Tajrish Hospital are randomly received intranasal placebo or insulin, every day, twice a day for 6 weeks. Motor and non-motor symptoms of patients are evaluated during the study in four times; baseline, 4, 8 and 12 weeks after treatments. Primary outcome is motor symptoms, and secondary outcomes including symptoms cognitive, memory, sleep disorders, depression, heart rate and postural hypertension).
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Participants/Inclusion and exclusion criteria
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Inclusion criteria:
Man and woman over 17 years old; Patient with Parkinson's disease according to UKPDSBB criteria; Patients with written informed consent.
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, 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.
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Intervention groups
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Control (placebo) and insulin groups
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Main outcome variables
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Score of motor symptoms at Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) questionnaire (Part III, IV)
General information
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Reason for update
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1- The phase of the study has been written as phase 3, thus it was been changed.
2- The duration of study was changed from 6 weeks to 12 weeks, and follow up duration was changed from every two weeks to every four weeks.
3- The study has been registered in WWW.clinicaltrials.gov, therefore, its information has added to the profile.
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Acronym
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IRCT registration information
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IRCT registration number:
IRCT20191022045196N1
Registration date:
2019-12-07, 1398/09/16
Registration timing:
prospective
Last update:
2021-03-02, 1399/12/12
Update count:
1
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Registration date
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2019-12-07, 1398/09/16
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Registrant information
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Recruitment status
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Recruitment complete
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Funding source
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Expected recruitment start date
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2020-01-21, 1398/11/01
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Expected recruitment end date
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2022-01-21, 1400/11/01
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Actual recruitment start date
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empty
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Actual recruitment end date
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empty
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Trial completion date
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empty
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Scientific title
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Evaluating the effect of intranasal insulin administration on motor and non-motor symptoms in Parkinson’s disease patients; a randomized double-blinded placebo-controlled clinical trial
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Public title
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Evaluating the effect of intranasal insulin administration on motor and non-motor symptoms in Parkinson’s disease patients; a randomized double-blinded placebo-controlled clinical trial
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Purpose
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Treatment
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Inclusion/Exclusion criteria
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Inclusion criteria:
Man and woman over 17 years old
Patient with Parkinson's disease according to UKPDSBB criteria
Provide written informed consent to participate in the study
Understand that they may withdraw their consent at any time.
Exclusion criteria:
1. Pregnant and lactating women
2. Patients with diabetes and taking anti-hyperglycemic drugs
3. Other neurodegenerative diseases like multiple system atrophy, Huntington's, Wilson's disease, Alzheimer's, ALS, progressive supranuclear palsy, etc.
4. Patients who cannot walk for more than one minute without help.
5. Patients with history of allergic reactions to insulin
6. Patients with history of nasal cavity inflammation that prevents insulin absorption
7. Patients with kidney and liver diseases
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Age
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From 17 years old
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Gender
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Both
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Phase
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2
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Groups that have been masked
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- Participant
- Care provider
- Investigator
- Outcome assessor
- Data analyser
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Sample size
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Target sample size:
40
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Randomization (investigator's opinion)
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Randomized
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Randomization description
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Simple randomization
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Blinding (investigator's opinion)
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Double blinded
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Blinding description
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Patients, researchers (physicians, outcome assessors) and data analysts are not aware about prescribed drugs.
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Placebo
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Used
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Assignment
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Parallel
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Other design features
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Secondary Ids
1
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Registry name
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مرکز ثبت کارآزمائي هاي باليني ايالات متحده آمريکا (www.clinicaltrial.gov)
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Secondary trial Id
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NCT04687878
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Registration date
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2020-12-29, 1399/10/09
Ethics committees
1
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Ethics committee
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Approval date
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2019-10-08, 1398/07/16
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Ethics committee reference number
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IR.SBMU.PHNS.REC.1398.094
Health conditions studied
1
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Description of health condition studied
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Parkinson's disease
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ICD-10 code
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ICD-10 code description
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Primary outcomes
1
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Description
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Score of motor symptoms
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Timepoint
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Motor symptoms score at the base line (before initiation the intervention) and 4, 8 and 12 weeks after intervention
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Method of measurement
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Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) questionnaire (Part III, IV)
Secondary outcomes
1
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Description
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Score of non-motor symptoms
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Timepoint
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Non-motor symptoms score at the base line (before initiation the intervention) and 4, 8 and 12 weeks after intervention
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Method of measurement
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Movement Disorder Society-Unified Parkinson's Disease Rating Scale (MDS-UPDRS) questionnaire (Part I, II)
2
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Description
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Score of depression
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Timepoint
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Depression score at the base line (before initiation the intervention) and 4, 8 and 12 weeks after intervention
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Method of measurement
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Beck's Depression Inventory II questionnaire
3
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Description
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Score of anxiety
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Timepoint
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Anxiety score at the base line (before initiation the intervention) and 4, 8 and 12 weeks after intervention
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Method of measurement
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Beck Anxiety Inventory (BAI) questionnaire
4
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Description
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Score of fatigue severity
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Timepoint
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fatigue score at the base line (before initiation the intervention) and 4, 8 and 12 weeks after intervention
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Method of measurement
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Fatigue Severity Scale (FSS) questionnaire
5
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Description
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Score of disease severity
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Timepoint
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severity score at the base line (before initiation the intervention) and 4, 8 and 12 weeks after intervention
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Method of measurement
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Modified Hoehn and Yahr (HY) questionnaire
6
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Description
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Score of cognitive symptoms
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Timepoint
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Cognitive symptoms score at the base line (before initiation the intervention) and 4, 8 and 12 weeks after intervention
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Method of measurement
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Montreal Cognitive Assessment (MOCA) questionnaire
7
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Description
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Score of cognitive symptoms
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Timepoint
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Cognitive symptoms score at the base line (before initiation the intervention) and 4, 8 and 12 weeks after intervention
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Method of measurement
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Scales for Outcomes of Parkinson’s disease-cognition (SCOPA-COG) questionnaire
8
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Description
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Score of Falling
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Timepoint
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Falling score at the base line (before initiation the intervention) and 4, 8 and 12 weeks after intervention
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Method of measurement
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Tinetti Balance Assessment Tool questionnaire
Intervention groups
1
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Description
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Control group: Placebo, intranasal administration, every day, twice a day, in both sides, for 12 weeks
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Category
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Behavior
2
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Description
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Intervention group: Insulin, intranasal administration, 40 IU/day, every day, twice a day, in both sides, for 12 weeks
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Category
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Behavior
1
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Sponsor
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Grant name
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Grant code / Reference number
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Is the source of funding the same sponsor organization/entity?
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Yes
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Title of funding source
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Shahid Beheshti University of Medical Sciences
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Proportion provided by this source
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100
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Public or private sector
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Public
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Domestic or foreign origin
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Domestic
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Category of foreign source of funding
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empty
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Country of origin
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Type of organization providing the funding
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Academic
Sharing plan
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Deidentified Individual Participant Data Set (IPD)
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Undecided - It is not yet known if there will be a plan to make this available
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Study Protocol
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Undecided - It is not yet known if there will be a plan to make this available
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Statistical Analysis Plan
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Undecided - It is not yet known if there will be a plan to make this available
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Informed Consent Form
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Undecided - It is not yet known if there will be a plan to make this available
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Clinical Study Report
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Undecided - It is not yet known if there will be a plan to make this available
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Analytic Code
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Undecided - It is not yet known if there will be a plan to make this available
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Data Dictionary
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Undecided - It is not yet known if there will be a plan to make this available