UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effects of isomaltodextrin (IMD) on glucose, insulin, glucagon and incretins: Comparison with maltodextrin in healthy volunteers
Title of the study (Brief title)	IMD-01
Region	Japan

Condition
Condition	Type 2 diabetes, obesity
Classification by specialty	Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	This cross-over trial is designed to compare effects of isomaltodextrin with those of maltodextrin on glucose, insulin, C-peptide, glucagon and incretins (GLP-1 and GIP).
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Plasma levels of GIP and GLP-1 before and after ingestion of IMD or MD; and their area under the curves
Key secondary outcomes	Levels of glucose, insulin, C-peptide, and glucagon before and after ingestion of IMD or MD; and their area under the curves

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Single blind -investigator(s) and assessor(s) are blinded
Control	Active
Stratification	NO
Dynamic allocation	NO
Institution consideration
Blocking
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Prevention
Type of intervention	Food
Interventions/Control_1	Isomaltodextrin (IMD) 50g
Interventions/Control_2	maltodextrin (MD) 50g
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	75 years-old >=
Gender	Male
Key inclusion criteria	1. Healthy volunteers without diabetes 2. Gender: Male and female 3. BMI(kg/m2) at screening: 18 or more; and 30 or less 4. Age (years) at screening: 20 or more; and 75 or less
Key exclusion criteria	1. Individuals receiving anti-diabetic drugs 2. Individuals with renal impairment 3. Individuals with hepatic impairment 4. Individuals with history of cerebrovascular disorders and/or ischemic heart diseases 5. Individuals with heart failure (NYHA I-IV) 6. Individuals with history of GI surgery 7. Individuals with excess alcohol consumption 8. Individuals with low Hb values: male, < 13.0g/dL and female 12.5 g/dL 9. Individuals who cannot follow orders from chief investigator or sub investigator 10. Individuals enrolled in other clinical trials 11. Pregnant individuals or those suspected of pregnancy 12. Individuals who are judged as inappropriate to be enrolled in this trials by chief investigator or sub investigators
Target sample size	12

Research contact person
Name of lead principal investigator	Susumu Seino
Organization	Kobe University Graduate School of Medicine
Division name	Division of Molecular and Metabolic Medicine
Address	1-5-6 Minatojimaminamimachi, Chuo-ku, Kobe 650-0047, Japan
TEL	078-304-6061
Email	seino@med.kobe-u.ac.jp

Public contact
Name of contact person	Daisuke Yabe
Organization	Kansai Electric Power Hospital
Division name	Center for Diabetes, Endocrinology and Metabolism
Address	2-1-7 Fukushima, Osaka 553-0003, Japan
TEL	06-6458-5821
Homepage URL
Email	ydaisuke-kyoto@umin.ac.jp

Sponsor
Institute	Division of Molecular and Metabolic Medicine, Kobe University Graduate School of Medicine
Institute
Department

Funding Source
Organization	Hayashibara Co., Ltd.
Organization
Division
Category of Funding Organization	Profit organization
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor	Kansai Electric Power Hospital
Name of secondary funｄer(s)

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	2016 Year 12 Month 17 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2015 Year 10 Month 19 Day
Anticipated trial start date	2016 Year 02 Month 22 Day
Last follow-up date	2016 Year 03 Month 31 Day
Date of closure to data entry	2016 Year 05 Month 31 Day
Date trial data considered complete	2016 Year 05 Month 31 Day
Date analysis concluded	2016 Year 06 Month 30 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2016 Year 12 Month 17 Day
Last modified on	2017 Year 05 Month 30 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024202