UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015385 |
|---|---|
| Receipt number | R000016968 |
| Scientific Title | The effect of miglitol on glucose, blood pressure, and heart rate variability in patients with type 2 diabetes. |
| Date of disclosure of the study information | 2014/10/10 |
| Last modified on | 2014/10/09 17:30:40 |
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Basic information
Public title
The effect of miglitol on glucose, blood pressure, and heart rate variability in patients with type 2 diabetes.
Acronym
Miglitol cardiovascular glycemic variability study
Scientific Title
The effect of miglitol on glucose, blood pressure, and heart rate variability in patients with type 2 diabetes.
Scientific Title:Acronym
Miglitol cardiovascular glycemic variability study
Region
| Japan |
Condition
Condition
Heart failure or acute myocardial infarction with type 2 diabetes.
Classification by specialty
| Cardiology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To elucidate the effect of postprandial glucose lowering by miglitol on blood pressure and heart rate variability in heart failure or acute myocardial infarction patients with type 2 diabetes.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
1. Change in circadian blood glucose levels assessed by continuous glucose monitoring (CGM)
2. Arrhythmia, heart rate variability, and T-wave alternans (TWA) assessed by Holter ECG monitoring.
Key secondary outcomes
1. Blood pressure and heart rate variability evaluated by ABPM.
Changes in circadian BP rhythm, BP level, and heart rate.
Base
Study type
Interventional
Study design
Basic design
Cross-over
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
| Medicine |
Interventions/Control_1
Group with miglitol first day
Interventions/Control_2
Group with miglitol second day
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. Stable HF patients with NYHA II or above
2. Patients with AMI who have finished rehabilitation, and just before leaving hospital.
3. HbA1c level 6.5% (NGSP) or more, or diagnosed as diabetes, or taking antdiabetic medications.
4. Age more than 20 yrs.
Key exclusion criteria
1. Patients with significant arrhythmia such as atrial fibrilation.
2. Patients with decompensated heart failure, fever, inflammation (CRP>1.0mg/dl)
3. Patients who are using insulin
4. Hepatic damage (AST, ALT >100 IU/L)
5. Patients with HBV, or HCV infection
6. Moderate renal dysfunction (serum creatinine >2.0mg/dl)
7. Patients with inflammatory bowel disease, colon ulcer, and bowel obstruction.
8. Severe chronic bowel diseases
9. Patients who have disease with increased bowel gas.
10. Patients with a history of gastric resection.
11. Lactose intolerance
12. Pregnant women or possible pregnancy.
13. Contraindication for miglitol
14. Dementia from whom we cannot obtain informed consent.
15. For whom the attending doctor considered he or she is not appropriate for the study.
Target sample size
20
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazuo Eguchi |
Organization
Jichi Medical University School of Medicine
Division name
Division of Cardiovascular Medicine, Department of Medicine
Zip code
Address
3311-1, Yakushiji, Shimotsuke, Tochigi, 329-0498, JAPAN
TEL
0285-58-7538
ke112@jichi.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kazuo Eguchi |
Organization
Jichi Medical University School of Medicine
Division name
Division of Cardiovascular Medicine, Department of Medicine
Zip code
Address
3311-1, Yakushiji, Shimotsuke, Tochigi, 329-0498, JAPAN
TEL
0285-58-7538
Homepage URL
ke112@jichi.ac.jp
Sponsor or person
Institute
Jichi Medical University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
Jichi Medical University School of Medicine
Organization
Division
Category of Funding Organization
Self funding
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
Other administrative information
Date of disclosure of the study information
| 2014 | Year | 10 | 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
Completed
Date of protocol fixation
| 2011 | Year | 09 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2011 | Year | 12 | Month | 20 | Day |
Last follow-up date
| 2013 | Year | 12 | Month | 20 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2014 | Year | 10 | Month | 09 | Day |
Last modified on
| 2014 | Year | 10 | Month | 09 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016968
