UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000015055 |
|---|---|
| Receipt number | R000017519 |
| Scientific Title | Taking metformin before a meal prevents postprandial hyperglycemia; a randomized, open-label, crossover pilot study. |
| Date of disclosure of the study information | 2015/08/01 |
| Last modified on | 2015/08/03 18:40:18 |
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Basic information
Public title
Taking metformin before a meal prevents postprandial hyperglycemia; a randomized, open-label, crossover pilot study.
Acronym
Taking metformin before meal
Scientific Title
Taking metformin before a meal prevents postprandial hyperglycemia; a randomized, open-label, crossover pilot study.
Scientific Title:Acronym
Taking metformin before meal
Region
| Japan |
Condition
Condition
diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Taking metformin with a meal has been shown to decrease its bioavailability. We hypothesized that taking metformin before a meal improves glucose metabolism.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
postprandial glucose level
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Cross-over
Randomization
Randomized
Randomization unit
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
| Medicine |
Interventions/Control_1
taking metformin with a meal(1000mg)->wash out->taking metformin 30 minutes before meal(1000mg)
Interventions/Control_2
taking metformin 30 minutes before meal(1000mg)->wash out->taking metformin with a meal(1000mg)
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
| 25 | years-old | <= |
Age-upper limit
| 60 | years-old | >= |
Gender
Male
Key inclusion criteria
We invited patients with type 2 diabetes who were being treated by metformin monotherapy and whose HbA1c was under 6.0% from Hospital of Kyoto Prefectural University of Medicine.
Key exclusion criteria
Allergy to metformin
Target sample size
8
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Michiaki Fukui |
Organization
Kyoto Prefectural University of Medicine, Graduate School of Medical Science
Division name
Department of Endocrinology and Metabolism
Zip code
Address
465 Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto
TEL
0752515506
sayarinapm@hotmail.com
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Muhei Tanaka |
Organization
Kyoto Prefectural University of Medicine, Graduate School of Medical Science
Division name
Department of Endocrinology and Metabolism
Zip code
Address
465 Kajii-cho, Kawaramachi-Hirokoji, Kamigyo-ku, Kyoto
TEL
0752515506
Homepage URL
muhei-t@koto.kpu-m.ac.jp
Sponsor or person
Institute
Kyoto Prefectural University of Medicine, Graduate School of Medical Science
Institute
Department
Personal name
Funding Source
Organization
Kyoto Prefectural University of Medicine, Graduate School of Medical Science
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
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
| 2015 | Year | 08 | Month | 01 | 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
| 2014 | Year | 10 | Month | 22 | Day |
Date of IRB
Anticipated trial start date
| 2014 | Year | 10 | Month | 22 | 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
| 2014 | Year | 09 | Month | 04 | Day |
Last modified on
| 2015 | Year | 08 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000017519
| 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 |
