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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000032368
Receipt No. R000036175
Scientific Title Effects of branched-chain amino acids supplementation on skeletal muscle mass and glucose and lipid metabolism in elderly patients with type 2 diabetes: a randomized controlled study
Date of disclosure of the study information 2018/06/01
Last modified on 2021/04/26

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Basic information
Public title Effects of branched-chain amino acids supplementation on skeletal muscle mass and glucose and lipid metabolism in elderly patients with type 2 diabetes: a randomized controlled study
Acronym BCAA supplementation in elderly patients with type 2 diabetes
Scientific Title Effects of branched-chain amino acids supplementation on skeletal muscle mass and glucose and lipid metabolism in elderly patients with type 2 diabetes: a randomized controlled study
Scientific Title:Acronym BCAA supplementation in elderly patients with 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 To examine the effects of branched-chain amino acids (BCAA) supplementation on skeletal muscle mass and glucose and lipid metabolism in elderly patients with type 2 diabetes.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Changes in skeletal muscle mass after 24-week intervention
Key secondary outcomes Changes in HbA1c levels, fasting plasma glucose, HOMA-IR, serum levels of total cholesterol, triglycerides, LDL cholesterol and HDL cholesterol, amino acid profiles, tryptophan metabolites, body weight, lean body mass, fat mass, muscle strength (leg extension), grip strength, standing balance ability (index of postural stability, one-leg standing time) and score of Quick Inventory of Depressive Symptomatology

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit Individual
Blinding Single blind -investigator(s) and assessor(s) are blinded
Control Active
Stratification NO
Dynamic allocation YES
Institution consideration Institution is not considered as adjustment factor.
Blocking NO
Concealment Central registration

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Food
Interventions/Control_1 BCAA 6g
Interventions/Control_2 Soy protein 7.5g
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
65 years-old <=
Age-upper limit
80 years-old >
Gender Male and Female
Key inclusion criteria 1. Patients with type 2 diabetes.
2. Changes in HbA1c levels over the past six months are less than 1 %.
Key exclusion criteria 1. Patients with diabetes caused by other than type 2 diabetes
2. Insulin treated patients
3. Patients with eGFR <30 ml/min/1.73m2
4. Patients with active preproliferative or proliferative diabetic retinopathy
5. Patients who do not indicate for exercise therapy due to bone and joint disease
6. Patients treated with glucocorticoids or anabolic steroids
7. Patients treated with growth hormone
Target sample size 80

Research contact person
Name of lead principal investigator
1st name Hiroaki
Middle name
Last name Suzuki
Organization Faculty of Medicine, University of Tsukuba
Division name Department of Internal Medicine (Endocrinology and Metabolism)
Zip code 305-8575
Address 1-1-1 Tennodai, Tsukuba, Ibaraki 305-8575 Jpanan
TEL 029-853-3053
Email hirosuzu@md.tsukuba.ac.jp

Public contact
Name of contact person
1st name Hiroaki
Middle name
Last name Suzuki
Organization Faculty of Medicine, University of Tsukuba
Division name Department of Internal Medicine (Endocrinology and Metabolism)
Zip code 305-8575
Address 1-1-1, Tennodai, Tsukuba, Ibaraki 305-8575, Jpanan
TEL 029-853-3053
Homepage URL
Email hirosuzu@md.tsukuba.ac.jp

Sponsor
Institute Department of Internal Medicine (Endocrinology and Metabolism)
Faculty of Medicine,
University of Tsukuba
Institute
Department

Funding Source
Organization Honjo International Scholarship Foundation
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization

Other related organizations
Co-sponsor Graduate School of Agricultural and Life Sciences / Faculty of Agriculture, The University of Tokyo
Name of secondary funder(s)

IRB Contact (For public release)
Organization Tsukuba Clinical Research & Development Organization
Address 2-1-1 Amakubo, Tsukuba, Ibaraki 305-8576 Japan
Tel 029-853-3914
Email rinshokenkyu@un.tsukuba.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

Other administrative information
Date of disclosure of the study information
2018 Year 06 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 35
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 No longer recruiting
Date of protocol fixation
2018 Year 04 Month 27 Day
Date of IRB
2018 Year 05 Month 11 Day
Anticipated trial start date
2018 Year 06 Month 01 Day
Last follow-up date
2021 Year 03 Month 31 Day
Date of closure to data entry
2021 Year 03 Month 31 Day
Date trial data considered complete
2021 Year 03 Month 31 Day
Date analysis concluded

Other
Other related information

Management information
Registered date
2018 Year 04 Month 24 Day
Last modified on
2021 Year 04 Month 26 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000036175

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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