UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000037949 |
|---|---|
| Receipt number | R000043258 |
| Scientific Title | Comparison of GI levels of superfine sugar and fructose in patients with type 2 diabetes or impaired glucose tolerance |
| Date of disclosure of the study information | 2019/09/06 |
| Last modified on | 2020/02/13 08:37:10 |
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Basic information
Public title
Comparison of GI levels of superfine sugar and fructose in patients with type 2 diabetes or impaired glucose tolerance
Acronym
Comparison of GI levels of superfine sugar and fructose in patients with type 2 diabetes or impaired glucose tolerance
Scientific Title
Comparison of GI levels of superfine sugar and fructose in patients with type 2 diabetes or impaired glucose tolerance
Scientific Title:Acronym
Comparison of GI levels of superfine sugar and fructose in patients with type 2 diabetes or impaired glucose tolerance
Region
| Japan |
Condition
Condition
Type 2 diabetes mellitus or impaired glucose tolerance
Classification by specialty
| Endocrinology and Metabolism |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
GI levels of superfine sugar and fructose will be measured in patients with type 2 diabetes or impaired glucose tolerance and compared with those in our previous study.
Basic objectives2
Others
Basic objectives -Others
GI levels of superfine sugar and fructose
Trial characteristics_1
Exploratory
Trial characteristics_2
Developmental phase
Not applicable
Assessment
Primary outcomes
GI levels of superfine sugar and fructose computed when glucose solution 50 g/150 mL is ingested as the reference diet
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
Dynamic allocation
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
No need to know
Intervention
No. of arms
2
Purpose of intervention
Prevention
Type of intervention
| Food |
Interventions/Control_1
Glucose solution 50 g as the reference diet will be ingested and blood glucose level up to 3 hours after ingestion will be measured to have an area under the blood glucose concentration profile (AUC).
Interventions/Control_2
Subjects will ingest superfine sugar (test diet 1) or fructose (test diet 2) equivalent to carbohydrate content 50 g. Blood glucose level will be measured up to 3 hours after ingestion to compute GI levels: AUC of test diet 1 or 2 / AUC of reference diet * 100.
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) Subjects who give voluntary consent to participate in the study after they fully understand the explanations on the objective, procedure, duration, and foreseeable disadvantages of the study
(2) Subjects aged 20 years or older and have diagnosed type 2 diabetes or impaired glucose tolerance, or have these status suspected from previous tests
(3) Subjects who are able to follow the study doctor's instructions and report subjective symptoms
Key exclusion criteria
(1) Present or history of hepatic disorder, renal disorder, cardiovascular disease, respiratory disease, endocrine system disease, metabolic disease, neurological disease, or psychiatric disease which is not relevant for enrollment in the study as determined by the principal investigator or sub-investigator during the pre-study examinations
(2) Present or history of serious allergy or hypersensitivity
(3) Known allergic symptoms or aggravation of such symptoms when consuming sugar or a similar product
(4) Present or history of drug or alcohol dependence
(5) Medical treatment for diabetes with:
a) insulin
b) GLP-1 receptor agonist, or
c) thiazolidine compound
(6) Medical treatment for diabetes with 2 or more medications
(7) Blood glucose level exceeding 200 mg/dL by self-measured glucometer before ingest of the reference diet
(8) Other subjects who are not eligible for the study as determined by the investigator
Target sample size
48
Research contact person
Name of lead principal investigator
| 1st name | Hisayoshi |
| Middle name | |
| Last name | Daito |
Organization
Medical Corporation Heishinkai OCROM Clinic
Division name
Director
Zip code
565-0853
Address
Kasuga, Suita-shi, Osaka , Japan
TEL
06-6330-8810
hisayoshi.daito@heishinkai.com
Public contact
Name of contact person
| 1st name | Hisayoshi |
| Middle name | |
| Last name | Daito |
Organization
Medical Corporation Heishinkai OCROM Clinic
Division name
Director
Zip code
565-0853
Address
Kasuga, Suita-shi, Osaka , Japan
TEL
06-6330-8810
Homepage URL
hisayoshi.daito@heishinkai.com
Sponsor or person
Institute
InCROM Inc.
Institute
Department
Personal name
Funding Source
Organization
None
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Medical Corporation Heishinkai ToCROM Clinic
InCROM Inc.
Name of secondary funder(s)
None
IRB Contact (For public release)
Organization
Medical Corporation Heishinkai OPHAC Hospital ERC
Address
4-1-29 Miyahara, Yodogawa-ku, Osaka-shi, Osaka 532-0003, Japan
Tel
06-6395-9000
sumiko.kawamoto@heishinkai.com
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
医療法人 平心会 OCROMクリニック（大阪府）/Medical Corporation Heishinkai OCROM Clinic (Osaka, Japan)
医療法人 平心会 ToCROMクリニック（東京都）/Medical Corporation Heishinkai ToCROM Clinic (Tokyo, Japan)
Other administrative information
Date of disclosure of the study information
| 2019 | Year | 09 | Month | 06 | 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 | 09 | Month | 02 | Day |
Date of IRB
| 2019 | Year | 09 | Month | 13 | Day |
Anticipated trial start date
| 2019 | Year | 09 | Month | 17 | Day |
Last follow-up date
| 2020 | 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 | 09 | Month | 06 | Day |
Last modified on
| 2020 | Year | 02 | Month | 13 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043258
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