UMIN-CTR Clinical Trial

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
Email	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
Email	hisayoshi.daito@heishinkai.com

Sponsor
Institute	InCROM Inc.
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000043258