UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000028500 |
|---|---|
| Receipt number | R000032616 |
| Scientific Title | Clinical trials on weight loss in obesity impaired glucose tolerance (IGT) patients and mild diabetic patients using FreeStyle Libre. |
| Date of disclosure of the study information | 2018/04/10 |
| Last modified on | 2023/02/13 17:30:39 |
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Basic information
Public title
Clinical trials on weight loss in obesity impaired glucose tolerance (IGT) patients and mild diabetic patients using FreeStyle libre.(Transitioned to jRCT)
Acronym
Clinical trials on weight loss in obesity impaired glucose tolerance (IGT) patients and mild diabetic patients using FreeStyle libre.
Scientific Title
Clinical trials on weight loss in obesity impaired glucose tolerance (IGT) patients and mild diabetic patients using FreeStyle Libre.
Scientific Title:Acronym
Clinical trials on weight loss in obesity impaired glucose tolerance (IGT) patients and mild diabetic patients using FreeStyle Libre.
Region
| Japan |
Condition
Condition
Obesity impaired glucose tolerance patient
Obese mild diabetic patient
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To clarify whether visualization of blood glucose variability becomes an effective self-monitoring index for strengthening obesity behavioral therapy
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Weight loss amount during 6 months after intervention
Key secondary outcomes
Improvement of impaired glucose tolerance evaluated by 75gOGTT at 6 months after intervention, improvement of HbA1c, blood pressure, serum lipid, serum uric acid value, serum transaminase value, dietary intake, Change in quantity, change in health-related QOL, blood glucose fluctuation data, pruritus feeling of the attachment part of FreeStyle libre, frequency of eruption,lipid mediator values before and 6 months after intervention
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
No treatment
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Device,equipment |
Interventions/Control_1
Place FreeStyle Libre for 6 months
Interventions/Control_2
Place FreeStyle Libre Pro for 2 weeks
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)Patients who are over 20 years of age at consent acquisition
2)Patients who do not meet the diagnostic criteria of IGT at 75 g OGTT or who are not using oral hypoglycemic drugs with HbA 1 c below 7.0%
3)Sex is not an issue
4)Outpatient
5)With regard to participation in this study, patients who gained document consent by their own voluntary intention
Key exclusion criteria
1)Patients participating in other clinical trials
2)Patients with severe skin disease on the upper arm
3)Patients using other implantable medical devices such as pacemakers
4)In addition, patients judged inappropriate by the doctor in charge of this study
5)Patients who do not have dyslipidemia or hyperuricemia among patients with BMI of 25kg/m2 or more and less than 30kg/m 2 diagnosed with IGT
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | Yushi |
| Middle name | |
| Last name | Yushi |
Organization
Kobe University Medical School Hospital
Division name
Diabetesï½¥Endocrine internal medicine
Zip code
650-0017
Address
7-5-2 Kusunokimachi, Chuo-ku, Kobe-shi Hyogo ken
TEL
078-382-5861
hirota@med.kobe-u.ac.jp
Public contact
Name of contact person
| 1st name | Yasushi |
| Middle name | |
| Last name | Nakagawa |
Organization
Kobe University Graduate School of Medicine
Division name
Diabetes / Endocrine Internal Science
Zip code
650-0017
Address
7-5-2 Kusunokimachi, Chuo-ku, Kobe-shi Hyogo ken
TEL
078-382-5861
Homepage URL
yasushi@med.kobe-u.ac.jp
Sponsor or person
Institute
kobe University Graduate School of Medicine Diabetes / Endocrine Internal Science
Institute
Department
Personal name
Funding Source
Organization
none
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
Kobe University Clinical Research Review Committee Secretariat
Address
7-5-2 Kusunokimachi, Chuo-ku, Kobe-shi Hyogo ken
Tel
078-382-6669
cerb@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
| 2018 | Year | 04 | Month | 10 | 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
40
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
Terminated
Date of protocol fixation
| 2018 | Year | 01 | Month | 18 | Day |
Date of IRB
| 2018 | Year | 01 | Month | 18 | Day |
Anticipated trial start date
| 2018 | Year | 05 | Month | 31 | Day |
Last follow-up date
| 2022 | Year | 01 | Month | 18 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Transitioned to jRCT, jRCTs052180079
Management information
Registered date
| 2017 | Year | 08 | Month | 02 | Day |
Last modified on
| 2023 | Year | 02 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032616
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
