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Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000028500
Receipt No. 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 2019/05/16

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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.
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 OGTT 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
Middle name
Last name Yushi Hirota
Organization Kobe University Medical School Hospital
Division name Diabetesï½¥Endocrine internal medicine
Zip code
Address 7-5-2 Kusunokimachi, Chuo-ku, Kobe-shi Hyogo ken
TEL 078-382-5861
Email hirota@med.kobe-u.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Yasushi Nakagawa
Organization Kobe University Graduate School of Medicine
Division name Diabetes / Endocrine Internal Science
Zip code
Address 7-5-2 Kusunokimachi, Chuo-ku, Kobe-shi Hyogo ken
TEL 078-382-5861
Homepage URL
Email yasushi@med.kobe-u.ac.jp

Sponsor
Institute kobe University Graduate School of Medicine Diabetes / Endocrine Internal Science
Institute
Department

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
Address
Tel
Email

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
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
2018 Year 01 Month 18 Day
Date of IRB
Anticipated trial start date
2018 Year 05 Month 31 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2017 Year 08 Month 02 Day
Last modified on
2019 Year 05 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000032616

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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