UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025938 |
|---|---|
| Receipt number | R000029821 |
| Scientific Title | Quantitative examination of pain threshold of intra-epidermal nerve terminal for diagnosis and staging of diabetic polyneuropathy |
| Date of disclosure of the study information | 2017/02/01 |
| Last modified on | 2023/01/09 08:57:15 |
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Basic information
Public title
Quantitative examination of pain threshold of intra-epidermal nerve terminal for diagnosis and staging of diabetic polyneuropathy
Acronym
Pain threshold of intra-epidermal nerve terminal in diabetic polyneuropathy
Scientific Title
Quantitative examination of pain threshold of intra-epidermal nerve terminal for diagnosis and staging of diabetic polyneuropathy
Scientific Title:Acronym
Pain threshold of intra-epidermal nerve terminal in diabetic polyneuropathy
Region
| Japan |
Condition
Condition
Diabetic polyneuropathy
Classification by specialty
| Medicine in general | Endocrinology and Metabolism | Neurology |
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the effectiveness of quantitative examination of pain threshold of intra-epidermal nerve terminal for diagnosis and staging of diabetic polyneuropathy
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Explanatory
Developmental phase
Not applicable
Assessment
Primary outcomes
1. Pain threshold of intra-epidermal nerve terminal
2. Corneal confocal microscopic findings
3. Nerve conduction studies
Relationship of these three examinations
Key secondary outcomes
1. Score of Michigan Neuropathy Screening Instrument(MNSI)
2. Clinical findings: i) Absent or hypoactive Achilles tendon reflexes, ii) Impaired vibration sensation
3. HbA1c, blood glucose
4. Coefficients of variance of RR intervals
5. Diabetic nephropathy, Diabetic retinopathy
6. Laboratory data, blood pressure
7. Safety
8. Iriscorder
9. Elctroretinography
10. Somatosensory evoked potentials; SEP
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| 20 | years-old | <= |
Age-upper limit
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Group 1: non-diabetic patients
Group 2: type 2 diabetic patients with HbA1c<=13.0%
Subgroup 2-1: without diabetic polyneuropathy
Subgroup 2-2: with diabetic polyneuropathy
Diagnosis of diabetic polyneuropathy is based on "simplified diagnostic criteria of diabetic polyneuropathy and suggested staging" proposed from the consensus of the Japanese study group of diabetic neuropathy
Key exclusion criteria
1. Pregnancy, lactation
2. Type 1 diabetes, other types of diabetes
3. Suffering from diabetic ketoacidosis
4. Severe infection, Severe injuries
5. Implanted a pacemaker, a defibrillator, or cochlear implant
6. Treatment with steroids
7. Current/Past malignancy
8. Inappropriate patients for entry on this study in the judgement of the investigator
Target sample size
90
Research contact person
Name of lead principal investigator
| 1st name | Jiro |
| Middle name | |
| Last name | Nakamura |
Organization
Aichi Medical University
Division name
Diabetes
Zip code
480-1195
Address
1-1 Yazakokarimata, Nagakute
TEL
0561-63-1683
jiro@aichi-med-u.ac.jp
Public contact
Name of contact person
| 1st name | Hideki |
| Middle name | |
| Last name | Kamiya |
Organization
Aichi Medical University
Division name
Diabetes
Zip code
480-1195
Address
1-1 Yazakokarimata, Nagakute
TEL
0561-63-1683
Homepage URL
hkamiya@aichi-med-u.ac.jp
Sponsor or person
Institute
Aichi Medical University
Institute
Department
Personal name
Funding Source
Organization
Aichi Medical University
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
Aichi Medical University School of Medicine
Address
1-1 Yazakokarimata, Nagakute, Aichi
Tel
0561-63-1683
thimeno@aichi-med-u.ac.jp
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 | 02 | Month | 01 | 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
Enrolling by invitation
Date of protocol fixation
| 2016 | Year | 06 | Month | 27 | Day |
Date of IRB
| 2016 | Year | 06 | Month | 27 | Day |
Anticipated trial start date
| 2016 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2025 | Year | 10 | Month | 30 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
1. cross-sectional study in non-diabetic or diabetic patients
2. Cases are selected from inpatients of Aichi Medical University
Management information
Registered date
| 2017 | Year | 01 | Month | 31 | Day |
Last modified on
| 2023 | Year | 01 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029821
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
