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Name:
UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000038314
Receipt No. R000043561
Scientific Title Impact of carbohydrate sources on HbA1c, BMI and visceral fat in elder patients with type 2 diabetes
Date of disclosure of the study information 2019/11/01
Last modified on 2019/10/16

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Basic information
Public title Impact of carbohydrate sources on HbA1c and BMI in elder patients with type 2 diabetes
Acronym Impact of carbohydrate sources on HbA1c and BMI in elder patients
Scientific Title Impact of carbohydrate sources on HbA1c, BMI and visceral fat in elder patients with type 2 diabetes
Scientific Title:Acronym Impact of carbohydrate sources on HbA1c, BMI and visceral fat in elder type 2 diabetes
Region
Japan

Condition
Condition type 2 diabetes
Classification by specialty
Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 Incremental rises in blood glucose after ingesting various carbohydrate sources differ greatly, but little information on the direct impacts of carbohydrate sources on HbA1c, BMI and visceral fat have been reported. We aimed to evaluate decreases in HbA1c,BMI and vesceral fat achieved by reducing carbohydrate from various sources in elder patients with type 2 diabetes.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1 Exploratory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes body weight, BMI, HbA1c, macronutrients and carbohydrate sources based on dietary records at baseline and 6 months later and the association of changes in carbohydrate sources with changes in the above parameters
Key secondary outcomes insulin, HOMA-IR and serum lipid profile at baseline and 6 months later and AUC-insulin by OGTT

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Behavior,custom
Interventions/Control_1 We treat patients with type 2 diabetes with a moderate low carbohydrate diet over 6 months. We instruct to reduce carbohydrate intake according to patients baseline carbohydrate intake and HbA1c levels. Two dietitians give the instruction to participants twice during the first month and once a month thereafter. We measure the body mass index and HbA1c levels every month and serum lipid profile, visceral fat by CT, dietary records and oral glucose tolerance test at baseline and 6 months later.
Interventions/Control_2
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 New Japanese outpatients with type 2 diabetes and HbA1c levels of 6.5% or above at Haimoto Clinic who do not take any type of oral hypoglycemic agent, insulin or steroid hormone from 3 months before baseline.
Key exclusion criteria taking any type of oral hypoglycemic agent, insulin or steroid hormone from 3 months before baseline that would impact HbA1c levels; following strict carbohydrate restriction at baseline based on commercial diet therapies such as the Atkins diet; serum creatinine levels greater than 2.0 mg/dl, ketoacidosis, soft drink ketosis, cancer or decompensatory liver cirrhosis.
Target sample size 160

Research contact person
Name of lead principal investigator
1st name Hajime
Middle name
Last name Haimoto
Organization Haimoto Clinic
Division name Department of Internal Medicine
Zip code 486-0838
Address 1-80 Yayoi-cho, Kasugai, Aichi 486-0838, Japan
TEL 0568-85-0568
Email haimoto@gol.com

Public contact
Name of contact person
1st name Hajime
Middle name
Last name Haimoto
Organization Haimoto Clinic
Division name Department of Internal Medicine
Zip code 486-0838
Address 1-80 Yayoi-cho, Kasugai, Aichi 486-0838, Japan
TEL 0568-85-0568
Homepage URL
Email haimoto@gol.com

Sponsor
Institute Haimoto Clinic
Institute
Department

Funding Source
Organization Haimoto Clinic
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 the Ethical Committee of Aichi Syukutoku University
Address 2-9 Katahira-cho, Nagakute, Aichi 480-1197, Japan
Tel 0561-62-4111
Email kmaeda@asu.aasa.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
2019 Year 11 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 Open public recruiting
Date of protocol fixation
2019 Year 08 Month 01 Day
Date of IRB
2019 Year 05 Month 15 Day
Anticipated trial start date
2019 Year 09 Month 01 Day
Last follow-up date
2022 Year 03 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
2019 Year 10 Month 16 Day
Last modified on
2019 Year 10 Month 16 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043561

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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