UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000021916
Receipt No. R000024434
Scientific Title The study to investigate quantitative neurological examinations for diagnosis and staging of diabetic polyneuropathy
Date of disclosure of the study information 2016/04/16
Last modified on 2016/10/12

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title The study to investigate quantitative neurological examinations for diagnosis and staging of diabetic polyneuropathy
Acronym The quantitative assessments of diabetic polyneuropathy
Scientific Title The study to investigate quantitative neurological examinations for diagnosis and staging of diabetic polyneuropathy
Scientific Title:Acronym The quantitative assessments of 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 some quantitative examinations including corneal confocal microscopy for diagnosis and staging of diabetic polyneuropathy
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes 1. Corneal confocal microscopic findings
2. Nerve conduction studies
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. Current potential threshold
9. Iriscorder
10. Elctroretinography

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%
Key exclusion criteria 1. Pregnancy, lactation
2. Severe infection, Severe injuries
3. Treatment with steroids
4. Current/Past malignancy
5. Allergic to anesthetic drugs
6. Inappropriate patients for entry on this study in the judgement of the investigator
Target sample size 60

Research contact person
Last name of lead principal investigator
1st name
Middle name
Last name Jiro Nakamura
Organization Aichi Medical University
Division name Diabetes
Zip code
Address 1-1 Yazakokarimata, Nagakute
TEL 0561-63-1683
Email jiro@aichi-med-u.ac.jp

Public contact
1st name of contact person
1st name
Middle name
Last name Hideki Kamiya
Organization Aichi Medical University
Division name Diabetes
Zip code
Address 1-1 Yazakokarimata, Nagakute
TEL 0561-63-1683
Homepage URL
Email hkamiya@aichi-med-u.ac.jp

Sponsor
Institute Aichi Medical University
Institute
Department

Funding Source
Organization Division of Diabetes, Department of Internal Medicine, 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
Address
Tel
Email

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
2016 Year 04 Month 16 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
2015 Year 11 Month 18 Day
Date of IRB
Anticipated trial start date
2016 Year 03 Month 01 Day
Last follow-up date
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
2016 Year 04 Month 15 Day
Last modified on
2016 Year 10 Month 12 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024434

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.