UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000056752 |
|---|---|
| Receipt number | R000064856 |
| Scientific Title | A Prospective Interventional Study to Estimate Glucose Tolerance Using Continuous Glucose Monitoring |
| Date of disclosure of the study information | 2025/01/18 |
| Last modified on | 2025/01/18 10:33:29 |
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Basic information
Public title
A Prospective Interventional Study to Estimate Glucose Tolerance Using Continuous Glucose Monitoring
Acronym
A Prospective Interventional Study to Estimate Glucose Tolerance Using Continuous Glucose Monitoring
Scientific Title
A Prospective Interventional Study to Estimate Glucose Tolerance Using Continuous Glucose Monitoring
Scientific Title:Acronym
A Prospective Interventional Study to Estimate Glucose Tolerance Using Continuous Glucose Monitoring
Region
| Japan |
Condition
Condition
Non-diabetes
Classification by specialty
| Endocrinology and Metabolism | Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Verify the validity of the parameter K estimated using the mathematical model F = KG to assess glucose tolerance based on continuous glucose monitoring.
Basic objectives2
Others
Basic objectives -Others
Evaluate the correlation between the glucose tolerance index K, estimated from glucose waveforms obtained through continuous glucose monitoring, and the glucose tolerance index calculated from the OGTT.
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Verify the validity of the parameter K estimated using the mathematical model F = KG to assess glucose tolerance based on continuous glucose monitoring.
Key secondary outcomes
The correlation between the glucose tolerance index K, estimated from glucose waveforms obtained through continuous glucose monitoring, and the glucose tolerance index calculated from the glucose clamp test.
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Prevention
Type of intervention
| Medicine | Food | Device,equipment |
Interventions/Control_1
Performing a 75gOGTT and glucose clamp test on non-diabetic individuals. Equip non-diabetic individuals with continuous glucose monitoring devices. Provide non-diabetic individuals with simple carbohydrates and mixed meals to consume.
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
(1) Individuals who have not been diagnosed with diabetes or who, despite a prior diagnosis, are not undergoing pharmacological treatment.
(2) Individuals aged 20 years or older.
(3) Individuals who have provided written informed consent to participate in this clinical study voluntarily.
Key exclusion criteria
(1) Individuals with a history of gastrointestinal surgery that could affect blood glucose changes or glucose tolerance (total gastrectomy, total colectomy, or bariatric surgery are excluded; endoscopic treatments and appendectomy are not excluded).
(2) Individuals with any skin condition (blisters, redness, swelling, rash, bleeding, infection, or purpura) at the CGM attachment site, such as the upper arm or abdomen.
(3) Individuals with a known history of hypersensitivity to the study drug.
(4) Individuals using medications that affect glucose metabolism (steroid preparations or beta-blockers).
(5) Individuals diagnosed within the past year with severe renal impairment ((eGFR 30 mL/min/1.73 m2 or less at the start of the study).
(6) Individuals diagnosed within the past year with severe cardiac disease (NYHA class III or higher).
(7) Individuals with coagulation disorders.
(8) Pregnant or potentially pregnant individuals, or those who are breastfeeding.
(9) Individuals undergoing treatment for malignant diseases.
(10) Individuals with psychiatric disorders or those lacking sufficient decision-making capacity to cooperate with the study.
(11) Individuals with endocrine disorders that could affect glucose tolerance (hyperthyroidism, pheochromocytoma).
(12) Any other individuals deemed inappropriate for participation by the investigator.
Target sample size
68
Research contact person
Name of lead principal investigator
| 1st name | Kazuhiko |
| Middle name | |
| Last name | Sakaguchi |
Organization
Kobe university
Division name
Department of Diabetes and Endocrinology
Zip code
650-0017
Address
7-5-2, Kusunoki-Cho, Chuo-ku, Kobe
TEL
078-382-5861
kzhkskgc@med.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | Kazuhiko |
| Middle name | |
| Last name | Sakaguchi |
Organization
Kobe university
Division name
Department of Diabetes and Endocrinology
Zip code
650-0017
Address
7-5-2, Kusunoki-Cho, Chuo-ku, Kobe
TEL
078-382-5861
Homepage URL
kzhkskgc@med.kobe-u.ac.jp
Sponsor or person
Institute
Kobe university
Institute
Department
Personal name
Funding Source
Organization
Others
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Intervention research ethics revies committee
Address
7-5-2, Kusunoki-Cho, Chuo-ku, Kobe
Tel
0783826669
kainyu@med.kobe-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
| 2025 | Year | 01 | Month | 18 | 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
Preinitiation
Date of protocol fixation
| 2025 | Year | 01 | Month | 17 | Day |
Date of IRB
Anticipated trial start date
| 2025 | Year | 04 | Month | 01 | Day |
Last follow-up date
| 2027 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2025 | Year | 01 | Month | 18 | Day |
Last modified on
| 2025 | Year | 01 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000064856
