UMIN-CTR Clinical Trial

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/icdr_e/ctr_view.cgi?recptno=R000038945