UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045988 |
|---|---|
| Receipt number | R000052241 |
| Scientific Title | Evaluation of Acceptance and Commitment Therapy on glycemic control in type 2 diabetes patients |
| Date of disclosure of the study information | 2021/11/05 |
| Last modified on | 2021/11/05 14:12:28 |
* 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
Evaluation of Acceptance and Commitment Therapy on glycemic control in type 2 diabetes patients
Acronym
ACTION
Scientific Title
Evaluation of Acceptance and Commitment Therapy on glycemic control in type 2 diabetes patients
Scientific Title:Acronym
ACTION
Region
| Japan |
Condition
Condition
Type 2 diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Evaluation of the effect of acceptance and commitment therapy on HbA1c change in type 2 diabetes
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change in HbA1c after 6 months
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Behavior,custom |
Interventions/Control_1
Receive medical treatment guidance by Acceptance and Commitment Therapy within 3 months of obtaining consent.
Receive nutritional guidance at 0, 3, 6, and 9 months.
Interventions/Control_2
Receive nutritional guidance at 0, 3, 6, and 9 months.
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
| 70 | years-old | > |
Gender
Male and Female
Key inclusion criteria
Patient with type 2 diabetes
Patient whose HbA1c level is 6-9%
Patients who have given their written consent
Key exclusion criteria
Patient who can not speak Japanese
Patient with cognitive disorder
Patient who have been admitted to the hospital with diabetes within 3 months prior to the date of consent
Patient who were changed in glucose-lowering drugs within 3 months prior to the date of consent
Patient who participated in other interventional studies
Target sample size
106
Research contact person
Name of lead principal investigator
| 1st name | Hisashi |
| Middle name | |
| Last name | Makino |
Organization
National Cerebral and Cardiovascular Center
Division name
Diabetes and Lipid metabolism
Zip code
564-8565
Address
6-1, KIshibeshinmachi, Osaka, Japan
TEL
+81661701070
makinoh@ncvc.go.jp
Public contact
Name of contact person
| 1st name | Hisashi |
| Middle name | |
| Last name | Makino |
Organization
National Cerebral and Cardiovascular Center
Division name
Diabetes and Lipid metabolism
Zip code
564-8565
Address
6-1, KIshibeshinmachi, Osaka, Japan
TEL
+81661701070
Homepage URL
makinoh@ncvc.go.jp
Sponsor or person
Institute
National Cerebral and Cardiovascular Center
Institute
Department
Personal name
Funding Source
Organization
Japanese Agency for Medical Research and Development
Organization
Division
Category of Funding Organization
Japanese Governmental office
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Research Ethics Review Committee of National Cerebral and Cardiovascular Center
Address
6-1, KIshibeshinmachi, Osaka, Japan
Tel
+81661701070
rec-office-ac@ncvc.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
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 11 | Month | 05 | 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
Open public recruiting
Date of protocol fixation
| 2021 | Year | 03 | Month | 10 | Day |
Date of IRB
| 2021 | Year | 04 | Month | 08 | Day |
Anticipated trial start date
| 2021 | Year | 07 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 02 | Month | 28 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 11 | Month | 05 | Day |
Last modified on
| 2021 | Year | 11 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000052241
