UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033362 |
|---|---|
| Receipt number | R000038027 |
| Scientific Title | Verification of multifaceted effects of konjac intake on type 2 diabetes |
| Date of disclosure of the study information | 2021/03/01 |
| Last modified on | 2021/03/01 14:48:27 |
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Basic information
Public title
Verification of multifaceted effects of konjac intake on type 2 diabetes
Acronym
Verification of multifaceted effects of konjac intake on type 2 diabetes
Scientific Title
Verification of multifaceted effects of konjac intake on type 2 diabetes
Scientific Title:Acronym
Verification of multifaceted effects of konjac intake on type 2 diabetes
Region
| Japan |
Condition
Condition
Type 2 diabetes mellitus
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
The aim of this study is to clarify the clinical effects of konnjac intake everyday on type 2 diabetic patients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in HbA1c after 12 week konnjac intake
Key secondary outcomes
1) Body weight, body mass index
2) Body composition / visceral fat level
3) Insulin resistance (insulin, HOMA-R)
4) The measured value of each blood test index related to glycolipid metabolism at each evaluation time point and the change amount from the value before ingesting the test food : hs-CRP, ghrelin, leptin, glucagon, GLP-1, LEAP 2, high molecular weight adiponectin, triglyceride, HDL-C, LDL-C, glucose.
5) The measured value of each blood biochemical test item other than 4) at the time of each evaluation and the change amount from the value before ingesting the test food.
6) Status of defecation
7) Quality of life
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
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
| Food |
Interventions/Control_1
Patients take konjac and/or konjac products everyday for 12 weeks with the effort target of 100g or more per day. Nutritional guidance is carried out at every monthly outpatient visit. During the intervention period, patients list a kind and the quantity of the konjac or konjac product which they take every day.
Interventions/Control_2
In the control group, they continue outpatient visit once a month with standard method. Nutritional guidance is carried out once.
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
| 75 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
Type 2 diabetic patients with insulin unuse, HbA1c 7.0 to 10%, and BMI 22 or more.
Key exclusion criteria
1. Patient who cannnot regulary visit h
ospital
2. Patient with advanced diabetic retin
opathy
3. Dialysis patient with diabetes
4. Patients with gastrointestinal disease (such as gastrectomy or Meckel diverticulum holder) in a state where ingestion of konjac is not recommended
5. Patients who have history of abdominal surgery and are at risk of bowel obstruction due to ingestion of konjac
6. Patients with severe ketosis, diabetic coma or anterior coma state
7. Patients with severe infections, before and after surgery, serious trauma
8. Patient who judged inappropriate d
ue to the complications and treatment
by attending doctor
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | Hiroaki |
| Middle name | |
| Last name | Ueno |
Organization
University of Miyazaki, fuculty of medicine
Division name
Neurology, Respirology, Endocrinology and Metabolism, Department of Internal Medicine
Zip code
889-1692
Address
5200 Kihara, Kiyotake, Miyazaki, Japan
TEL
0985-85-2965
intron@med.miyazaki-u.ac.jp
Public contact
Name of contact person
| 1st name | Hiroaki |
| Middle name | |
| Last name | Ueno |
Organization
University of Miyazaki, fuculty of medicine
Division name
Neurology, Respirology, Endocrinology and Metabolism, Department of Internal Medicine
Zip code
889-1692
Address
5200 Kihara, Kiyotake, Miyazaki, Japan
TEL
0985-85-2965
Homepage URL
intron@med.miyazaki-u.ac.jp
Sponsor or person
Institute
University of Miyazaki, fuculty of medicine, Neurology, Respirology, Endocrinology and Metabolism, Department of Internal Medicine
Institute
Department
Personal name
Funding Source
Organization
General Foundation Japan konjac Association
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Koga General Hospital
Miyazaki Prefectural Miyazaki Hospital
Name of secondary funder(s)
IRB Contact (For public release)
Organization
University of Miyazaki Hospital, Clinical Research Support Center
Address
5200 Kihara, Kiyotake, Miyazaki, Japan
Tel
0985-85-1510
rinken@med.miyazaki-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
宮崎大学医学部附属病院
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 03 | 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
| 2018 | Year | 08 | Month | 15 | Day |
Date of IRB
| 2018 | Year | 10 | Month | 01 | Day |
Anticipated trial start date
| 2018 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2021 | Year | 03 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 07 | Month | 11 | Day |
Last modified on
| 2021 | Year | 03 | Month | 01 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038027
| Research Plan | |
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| 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 |
