UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000034160 |
|---|---|
| Receipt number | R000038945 |
| Scientific Title | Effect of Whey Protein Supplement on Plasma Glucose Levels in Japanese Patients with Inadequately Controlled Type 2 Diabetes |
| Date of disclosure of the study information | 2020/12/31 |
| Last modified on | 2021/03/18 12:11:09 |
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Basic information
Public title
Effect of Whey Protein Supplement on Plasma Glucose Levels in Japanese Patients with Inadequately Controlled Type 2 Diabetes
Acronym
Effect of Whey Protein Supplement on Plasma Glucose Levels
Scientific Title
Effect of Whey Protein Supplement on Plasma Glucose Levels in Japanese Patients with Inadequately Controlled Type 2 Diabetes
Scientific Title:Acronym
Effect of Whey Protein Supplement on Plasma Glucose Levels
Region
| Japan |
Condition
Condition
Type 2 diabetes
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Inspect the effect of whey protein supplement on plasma glucose levels
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
The change of the HbA1c from baseline in the whey protein supplement performed after each 12 weeks
Key secondary outcomes
The change of the GA, GLP-1, GIP and PYY from baseline in the whey protein supplement performed after each 12 weeks
And the change of body composition by the Bioelectrical Impedance Analysis
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
Trained nutritionists calculate ideal body weight and assess their daily diet.
Interventions/Control_2
Patients were instructed to add on 10% of total energy by whey protein supplement.
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)Outpatients.
2)HbA1c before clinical trial start is 7.0% or more and 8.0% less.
3)Over 20years old. Gender unquestioned.
4)Patients are being treated DPP-4 inhibitor for more than 6 months,and variation of HbA1c by <0.5% whithin 3 months before recruitment.
5)Written informed consent was obtained from all participants.
Key exclusion criteria
1)Type1 diabetic patients and Type2 diabetic patients who depend on insulin.
2)Patients have renal failure (estimated glomerular filtration rate <60mL/min/1.73m2).
3)Patients have severe liver disfunction.
4)Women who may be pregnant, may become pregnant and are breastfeeding.
5)Patients have malignancy or had treated to malignancy past five years.
6)Patients have admission to improve glycemic control within a past year before written consent.
7)Patients are using a drug with the influence for glucose metabolism (steroid, interferon, hormone drugs, antipsychotic drugs and antitubercular drugs).
8)Patients have allergy to protein or dairy product.
9)Patients who were judged to be ineligible by the investigator.
Target sample size
70
Research contact person
Name of lead principal investigator
| 1st name | Yasushi |
| Middle name | |
| Last name | Tanaka |
Organization
St. Marianna University School of Medicine
Division name
Division of Metabolism and endocrinology, Depertment of Internal Medicine
Zip code
2168511
Address
2-16-1 Sugao, Miyamae-ku, Kawaski, Kanagawa, Japan.
TEL
044-977-8111
smu.tainai@gmail.com
Public contact
Name of contact person
| 1st name | Yutaro |
| Middle name | |
| Last name | Yamamoto |
Organization
St. Marianna University School of Medicine
Division name
Division of Metabolism and endocrinology, Depertment of Internal Medicine
Zip code
2168511
Address
2-16-1 Sugao, Miyamae-ku, Kawaski, Kanagawa, Japan.
TEL
044-977-8111
Homepage URL
y3yamamoto@marianna-u.ac.jp
Sponsor or person
Institute
St. Marianna University School of Medicine
Institute
Department
Personal name
Funding Source
Organization
None
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
St. Marianna University School of Medicine
Address
2-16-1 Sugao, Miyamae-ku, Kawaski, Kanagawa, Japan.
Tel
044-977-8111
k-sienbu.mail@marianna-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
聖マリアンナ医科大学病院（神奈川県）
Other administrative information
Date of disclosure of the study information
| 2020 | Year | 12 | Month | 31 | Day |
Related information
URL releasing protocol
none
Publication of results
Unpublished
Result
URL related to results and publications
none
Number of participants that the trial has enrolled
0
Results
Stopped as it falls under specific clinical research.
Results date posted
| 2021 | Year | 03 | Month | 18 | Day |
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
none
Participant flow
none
Adverse events
none
Outcome measures
none
Plan to share IPD
IPD sharing Plan description
Progress
Recruitment status
Terminated
Date of protocol fixation
| 2018 | Year | 05 | Month | 07 | Day |
Date of IRB
| 2018 | Year | 05 | Month | 15 | Day |
Anticipated trial start date
| 2018 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 12 | Month | 31 | 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 | 09 | Month | 15 | Day |
Last modified on
| 2021 | Year | 03 | Month | 18 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038945
