UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025276 |
|---|---|
| Receipt number | R000029062 |
| Scientific Title | Intranasal Insulin for Enhancement of Declarative Memory |
| Date of disclosure of the study information | 2017/06/30 |
| Last modified on | 2019/12/31 03:55:26 |
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Basic information
Public title
Intranasal Insulin for Enhancement of Declarative Memory
Acronym
Effects of Intranasal insulin on the declarative memory of healthy volunteers.
Scientific Title
Intranasal Insulin for Enhancement of Declarative Memory
Scientific Title:Acronym
Effects of Intranasal insulin on the declarative memory of healthy volunteers.
Region
| Asia(except Japan) |
Condition
Condition
Healthy volunteers
Classification by specialty
| Endocrinology and Metabolism | Neurology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To elucidate the effects of intranasal insulin on the declarative memory of healthy volunteers.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Enhancement of declerative memory in healthy individuals after 4 weeks of intranasal insulin treatment
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Double blind -all involved are blinded
Control
Placebo
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
40 IU of intranasal regular insulin dissolved in 0.9% saline per day, in four divided doses, for four weeks.
Interventions/Control_2
0.9% saline (placebo) four times a day, for four weeks.
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10
Eligibility
Age-lower limit
| 18 | years-old | < |
Age-upper limit
| 60 | years-old | > |
Gender
Male and Female
Key inclusion criteria
students in institutes of higher education
those that have been through higher education
Age >18yrs
Key exclusion criteria
Any pre-existing medical condition
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Omar Abbas Ahmed Malik |
Organization
Dow University of Health Sciences
Division name
Dow Medical College
Zip code
Address
31/1, Zulfiqar Street 1, Phase 8, DHA, Karachi, Pakistan
TEL
00923362363569
omar.a.a.malik@gmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Omar Abbas Ahmed Malik |
Organization
Dow University of Health Sciences
Division name
Dow Medical College
Zip code
Address
31/1, Zulfiqar Street 1, Phase 8, DHA, Karachi, Pakistan
TEL
00923362363569
Homepage URL
omar.a.a.malik@gmail.com
Sponsor or person
Institute
Jinnah Postgraduate Medical Centre
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
Secondary IDs
Secondary IDs
NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW
Institutions
Institutions
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 06 | Month | 30 | Day |
Related information
URL releasing protocol
Publication of results
Unpublished
Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Suspended
Date of protocol fixation
| 2016 | Year | 10 | Month | 01 | Day |
Date of IRB
| 2016 | Year | 01 | Month | 01 | Day |
Anticipated trial start date
| 2016 | Year | 12 | Month | 30 | Day |
Last follow-up date
| 2017 | Year | 01 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2016 | Year | 12 | Month | 14 | Day |
Last modified on
| 2019 | Year | 12 | Month | 31 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029062
