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Name:
UMIN ID:

Recruitment status Terminated
Unique ID issued by UMIN UMIN000034160
Receipt No. 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

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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
Email 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
Email y3yamamoto@marianna-u.ac.jp

Sponsor
Institute St. Marianna University School of Medicine
Institute
Department

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
Email 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000038945

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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