UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056505 |
|---|---|
| Receipt number | R000064573 |
| Scientific Title | Development and Validation of a Non-Invasive Scalp Hair Tool to Assess Diabetes Risk in Beauty Salons: The TellMe Study |
| Date of disclosure of the study information | 2024/12/19 |
| Last modified on | 2024/12/19 19:56:12 |
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Basic information
Public title
Development and Validation of a Non-Invasive Scalp Hair Tool to Assess Diabetes Risk in Beauty Salons: The TellMe Study
Acronym
The TellMe Study
Scientific Title
Development and Validation of a Non-Invasive Scalp Hair Tool to Assess Diabetes Risk in Beauty Salons: The TellMe Study
Scientific Title:Acronym
The TellMe Study
Region
| Japan |
Condition
Condition
Diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To investigate the relationship between blood HbA1c and hair glycated proteins and to calculate a cut-off value that predicts diabetes
Basic objectives2
Others
Basic objectives -Others
To investigate the relationship between blood HbA1c and hair glycated proteins and to calculate a cut-off value that predicts diabetes
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Not applicable
Assessment
Primary outcomes
Glycated protein and HbA1c in the hair are measured, and ROC (Receiver Operating Characteristic analysis) is used to calculate the Area Under the Curve (AUC) and cut-off value to predict diabetes.
Key secondary outcomes
The AUC and cut-off values of hair glycated proteins are calculated to predict the respective HbA1c category (less than 5.7%, 5.7-6.4%, 6.5% or more) or prediabetes (HbA1c 5.7-6.4% without the use of diabetes drugs).
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
| 64 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Age 20^64 years old
Key exclusion criteria
Those who cannot collect hair
Those who cannot measure glycated proteins in hair
Those who have difficulty obtaining informed consent from the research subject himself / herself
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Yuika |
| Middle name | |
| Last name | Kishi |
Organization
National Hospital Organization Osaka National Hospital
Division name
Diabetes center
Zip code
540-0006
Address
Osaka, Osaka-shi, Chuo-ku, Hoenzaka 2-1-14
TEL
06-6942-1331
kishi.yuika.bs@mail.hosp.go.jp
Public contact
Name of contact person
| 1st name | Yuika |
| Middle name | |
| Last name | Kishi |
Organization
National Hospital Organization Osaka National Hospital
Division name
Diabetes center
Zip code
540-0006
Address
Osaka, Osaka-shi, Chuo-ku, Hoenzaka 2-1-14
TEL
06-6942-1331
Homepage URL
kishi.yuika.bs@mail.hosp.go.jp
Sponsor or person
Institute
National Hospital Organization Osaka National Hospital
Institute
Department
Personal name
Yuika Kishi
Funding Source
Organization
Tellme Solutions Co
Organization
Division
Category of Funding Organization
Profit organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Clinical Research Institute- NHO Kyoto Medical Center, Division of Preventive Medicine
NHO Kyoto Medical Center, Clinical Nutrition & Diabetes Center
Tellme Solutions Co
Kinki Bunseki Center Co.-Ltd, Compliance Promotion Department
Name of secondary funder(s)
IRB Contact (For public release)
Organization
National Hospital Organization Osaka Medical Center Commissioned Research Review Committee 2nd Committee
Address
Osaka, Osaka-shi, Chuo-ku, Hoenzaka 2-1-14
Tel
06-6942-1331
408-chiken@mail.hosp.go.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
独立行政法人国立病院機構大阪医療センター（大阪府）
Other administrative information
Date of disclosure of the study information
| 2024 | Year | 12 | Month | 19 | 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
| 2024 | Year | 12 | Month | 06 | Day |
Date of IRB
| 2024 | Year | 12 | Month | 18 | Day |
Anticipated trial start date
| 2024 | Year | 12 | Month | 19 | Day |
Last follow-up date
| 2025 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Data from approximately 200 participants, both with and without diabetes, will be collected at the NHO Osaka Medical Center between 19th December 2024 and 31st March 2025. Written informed consent will be obtained from all participants for being included in the study. Demographic information, medical history, diabetes risk factors, and other relevant clinical data will be documented. Glycation of hair protein will be measured using luminol chemiluminescence. Correlation analysis will be performed using Spearman's correlation coefficient. Optimal cut-off points for predicting diabetes will be established using receiver operating characteristic curves. AUC greater than 0.9 are considered as excellent, 0.8~0.9 as very good, 0.7~0.8 as good, 0.6~0.7 as sufficient, 0.5~0.6 as bad and lower than 0.5 as test not useful. Statistical significance was defined as p<0.05.
Management information
Registered date
| 2024 | Year | 12 | Month | 19 | Day |
Last modified on
| 2024 | Year | 12 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064573
