UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000017800 |
|---|---|
| Receipt number | R000020623 |
| Scientific Title | Observational study for detailed blood sugar (BS) fluctuation in myotoic dystrophy by continuous glucose monitoring (CGM) |
| Date of disclosure of the study information | 2015/06/15 |
| Last modified on | 2018/12/08 10:16:16 |
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Basic information
Public title
Observational study for detailed blood sugar (BS) fluctuation in myotoic dystrophy by continuous glucose monitoring (CGM)
Acronym
BS fluctuation in myotonic dystrophy: CGM observational study
Scientific Title
Observational study for detailed blood sugar (BS) fluctuation in myotoic dystrophy by continuous glucose monitoring (CGM)
Scientific Title:Acronym
BS fluctuation in myotonic dystrophy: CGM observational study
Region
| Japan |
Condition
Condition
Myotonic dystrophy type 1
Amyotrophic neuromuscular disease
Classification by specialty
| Endocrinology and Metabolism | Neurology |
Classification by malignancy
Others
Genomic information
YES
Objectives
Narrative objectives1
To clear BS fluctuation in myotonic dystrophy
Basic objectives2
Others
Basic objectives -Others
Observation of BS fluctuation
Trial characteristics_1
Others
Trial characteristics_2
Others
Developmental phase
Not applicable
Assessment
Primary outcomes
Index by CGM (mean BS, SD of BS, M value, MAGE, BS area, proportion of hypoglycemia or hyperglycemia) and routine blood examination
Key secondary outcomes
Results of oral glucose tolerance test
Base
Study type
Observational
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
| 18 | years-old | <= |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
1.Genetically diagnosed case in myotonic dystrophy
2.Fasting BS < 130mg/dl and HbA1c < 7.0%
3.Without limitation for stage or severity of disease
Key exclusion criteria
1.Medicated by insulin, DPP-4 inhibitor or GLP-1 agonist
2.Serious infection, perioperative
or serious injury
3.Cardio-vascular event
4.Serious liver damage
5.Moderate or serious renal damage
6.Moderate or serious heart failure
7.Gestation or lactation period
8.Short bowel syndrome
9.Medicated by steroid, interferon, hormonal agent, atypical antipsychotic
10.Emaciation or skin disease with difficulty to be attached CGM
11.No informed consent with a form
12.Assessed as inadequate by a physician in charge
Target sample size
40
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Hiroto TAKADA |
Organization
National Aomori Hospital
Division name
Neurology
Zip code
Address
155-1 Namioka-Megasawa-Hirano, Aomori, Japan
TEL
+81-172-62-4055
takada@aomorihosp.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Hiroto TAKADA |
Organization
National Aomori Hospital
Division name
Neurology
Zip code
Address
155-1 Namioka-Megasawa-Hirano, Aomori, Japan
TEL
+81-172-62-4055
Homepage URL
http://plaza.umin.ac.jp/~DM-CTG/index.html
takada@aomorihosp.jp
Sponsor or person
Institute
Dystrophia Myotonica: Clinical Treatment Group
Institute
Department
Personal name
Funding Source
Organization
MHLW(Japan)
Health and labor science research
Organization
Division
Category of Funding Organization
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
Address
Tel
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
国立病院機構青森病院（青森県）Aomori National Hospital
国立病院機構刀根山病院（大阪府）Toneyama National Hospital
国立病院機構大牟田病院（福岡県）Omuta National Hospital
国立病院機構兵庫中央病院（兵庫県）Hyogo-chuo National Hospital
国立病院機構旭川医療センター（北海道）Asahikawa National Hospital
大阪大学大学院医学研究科（大阪府）Graduate school of medicine Osaka University
Other administrative information
Date of disclosure of the study information
| 2015 | Year | 06 | Month | 15 | Day |
Related information
URL releasing protocol
http://plaza.umin.ac.jp/~DM-CTG/index.html
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
| 2015 | Year | 04 | Month | 16 | Day |
Date of IRB
Anticipated trial start date
| 2015 | Year | 06 | Month | 15 | Day |
Last follow-up date
| 2019 | Year | 03 | Month | 31 | Day |
Date of closure to data entry
| 2019 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2019 | Year | 03 | Month | 31 | Day |
Date analysis concluded
| 2019 | Year | 12 | Month | 31 | Day |
Other
Other related information
Index by CGM (mean BS, SD of BS, M value, MAGE, BS area, proportion of hypoglycemia or hyperglycemia) and routine blood examination, and resultsu of oral glucose tolerance test are observed.
Management information
Registered date
| 2015 | Year | 06 | Month | 03 | Day |
Last modified on
| 2018 | Year | 12 | Month | 08 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020623
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
