UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000038314 |
|---|---|
| Receipt number | R000043561 |
| Scientific Title | Impact of carbohydrate and its sources on visceral fat and non-alcoholic fatty liver in patients with type 2 diabetes |
| Date of disclosure of the study information | 2019/11/01 |
| Last modified on | 2023/12/19 14:49:10 |
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Basic information
Public title
Impact of carbohydrate and its sources on BMI, visceral fat and non-alcoholic fatty liver in patients with type 2 diabetes
Acronym
Impact of carbohydrate and its sources on visceral fat and non-alcoholic fatty liver in diabetes patients
Scientific Title
Impact of carbohydrate and its sources on visceral fat and non-alcoholic fatty liver in patients with type 2 diabetes
Scientific Title:Acronym
Impact of carbohydrate ant its sources on visceral fat and fatty liver in diabetes patients
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 ant its sources on BMI, visceral fat and non-alcoholic fatty liver have been reported. We aimed to evaluate changes in BMI, visceral fat and non-alcoholic fatty liver achieved by reducing carbohydrate from various sources in 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
BMI and visceral fat by CT and CT value in the liver and spleen, macronutrients and carbohydrate sources based on dietary records at baseline and 6 months, 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
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. A Dietitian gives 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 and CT value in the liver and spleen, 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
| 25 | 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 and alcoholic fatty liver disease.
Target sample size
300
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
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
haimoto@gol.com
Sponsor or person
Institute
Haimoto Clinic
Institute
Department
Personal name
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
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 | 11 | Month | 22 | Day |
Anticipated trial start date
| 2019 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2023 | Year | 09 | Month | 30 | Day |
Date of closure to data entry
| 2023 | Year | 11 | Month | 30 | Day |
Date trial data considered complete
| 2023 | Year | 12 | Month | 31 | Day |
Date analysis concluded
| 2024 | Year | 03 | Month | 31 | Day |
Other
Other related information
Management information
Registered date
| 2019 | Year | 10 | Month | 16 | Day |
Last modified on
| 2023 | Year | 12 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043561
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