UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000055889 |
|---|---|
| Receipt number | R000063871 |
| Scientific Title | A study to determine the effective timing and intensity of interventions to reduce the progression from impaired glucose tolerance to type 2 diabetes mellitus |
| Date of disclosure of the study information | 2024/10/21 |
| Last modified on | 2024/10/20 21:21:13 |
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Basic information
Public title
A study to determine the effective timing and intensity of interventions to reduce the progression from impaired glucose tolerance to type 2 diabetes mellitus
Acronym
A study to determine the effective timing and intensity of interventions to reduce the progression from impaired glucose tolerance to type 2 diabetes mellitus
Scientific Title
A study to determine the effective timing and intensity of interventions to reduce the progression from impaired glucose tolerance to type 2 diabetes mellitus
Scientific Title:Acronym
Study of timing and intensity of intervention for glucose impaired tolerance
Region
| Japan |
Condition
Condition
Impaired Glucose Tolerance (IGT)
Classification by specialty
| Medicine in general | Cardiology | Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To determine the timing and intensity of interventions for persons with impaired glucose tolerance
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Hazard ratios for the development of type 2 diabetes mellitus
Key secondary outcomes
Base
Study type
Others,meta-analysis etc
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
| 19 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1. RCT trials investigating the effects of preventing the progression of type 2 diabetes mellitus
2. English language articles
3. Full-text available
Key exclusion criteria
1. Trials where inhibition of progression of type 2 diabetes mellitus has not been studied
2. Trials for which 2-hour post-load blood glucose values are not available
3. Trials not including IGT (subjects with normal glucose, impaired fasting glucose (IFG) only, diabetes mellitus, other diseases (e.g., nephropathy))
4. Adults (19 years of age or older)
5. Not pregnant
6. Trials examining drugs other than diabetes mellitus medications
7. Trials with a follow-up period of less than 6 months
8. Trials for which the number of events for the outcome is not available
9. Not an Article
Target sample size
Research contact person
Name of lead principal investigator
| 1st name | Kotoba |
| Middle name | |
| Last name | Okuyama |
Organization
Toho University
Division name
Department of Medical Statistics, Graduate School of Medicine
Zip code
143-8540
Address
5-21-16 Omori-nishi, Ota-ku, Tokyo 143-8540, Japan
TEL
03-3762-4151
md19013o@st.toho-u.jp
Public contact
Name of contact person
| 1st name | Kotoba |
| Middle name | |
| Last name | Okuyama |
Organization
Toho University
Division name
Department of Medical Statistics, Graduate School of Medicine
Zip code
143-8540
Address
5-21-16 Omori-nishi, Ota-ku, Tokyo 143-8540, Japan
TEL
03-3762-4151
Homepage URL
md19013o@st.toho-u.jp
Sponsor or person
Institute
Toho University
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
NA
Address
NA
Tel
NA
NA
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
| 2024 | Year | 10 | Month | 21 | 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
| 2024 | Year | 10 | Month | 21 | Day |
Date of IRB
Anticipated trial start date
| 2024 | Year | 10 | Month | 21 | Day |
Last follow-up date
| 2024 | Year | 12 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Information to be obtained from literature:
1. Follow-up period (mean or median)
2. Baseline 2-hour post-glucose glucose (group combined mean)
3. Mean change from baseline to the most recent post-intervention 2-hour post-glucose glucose level for each group
4. Baseline fasting blood glucose (group combined mean)
5. Mean change from baseline to most recent post-intervention fasting plasma glucose in each group
6. Baseline HbA1c (group combined mean)
7. Baseline age (combined group mean)
8. Baseline BMI (combined group mean)
9. Baseline IGT percentage (%)
10. Hazard ratio
11. Number of cases in each group and number of patients who progressed to type 2 diabetes mellitus
Risk of bias:
Assessed with the Cochrane risk of bias (RoB) Tool.
Statistical analysis: Meta-regression
Statistical analysis software: SAS 9.4 or higher
Management information
Registered date
| 2024 | Year | 10 | Month | 20 | Day |
Last modified on
| 2024 | Year | 10 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000063871
