UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Development of hyperglycemic glucose clamp methods and evaluation of its outcomes in healthy subjects
Title of the study (Brief title)	Development of hyperglycemic glucose clamp methods and evaluation of its outcomes in healthy subjects
Region	Japan

Condition
Condition	Diabetes mellitus
Classification by specialty	Endocrinology and Metabolism Adult
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To develop the series of methods to safely maintain hyperglycemic plateau, and to evaluate its outcomes, when hyperglycemic clamp technique is used in healthy male subjects.
Basic objectives2	Safety
Basic objectives -Others
Trial characteristics_1	Exploratory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Evaluation of hyperglycemic glucose clamp technique. Evaluation of the parameters of the first- and second- insulin secretory ability, and the transitions of glucose, insulin and c-peptide
Key secondary outcomes	Safety by evaluating AEs, serum potassium, and VAS for pain.

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	Prevention
Type of intervention	Maneuver
Interventions/Control_1	Hyperglycemic glucose clamp technique. 120 minute clamp/ subject
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	20 years-old <=
Age-upper limit	40 years-old >=
Gender	Male
Key inclusion criteria	1, Healthy Japanese male subjects who provide signed written informed consent. 2, Subjects between 20 and 40 (inclusive) year of age at the time of consent. 3, Subjects with BMI <=18.5 and >25.0 at the time of screening. 4, Subjects with negative serological tests. 5, Subject judged as adequate for this study by study physician at screening.
Key exclusion criteria	1, Subjects with present and/or past illness considered inadequate for this study. 2, Subjects with past history of drug allergy. 3, Subjects with history of caffeine, alcohol and/or drug abuse. 4, Subjects who was judged not appropriate for this study by study physician.
Target sample size	6

Research contact person
Name of lead principal investigator	Masanari Shiramoto
Organization	SOUSEIKAI Hakata Clinic
Division name	Clinical Pharmacology Department
Address	Random Square (5th-7th floors) 6-18 Tenyamachi, Hakata-ku, Fukuoka, 812-0025
TEL	0922837701
Email	masanari-shiramoto@lta-med.com

Public contact
Name of contact person	Hinako Uchimaru
Organization	SOUSEIKAI Hakata Clinic
Division name	Planning & Coordination Dept
Address	Random Square (5th-7th floors) 6-18 Tenyamachi, Hakata-ku, Fukuoka, 812-0025
TEL	0922837701
Homepage URL
Email	hinako-uchimaru@lta-med.com

Sponsor
Institute	SOUSEIKAI Hakata Clinic
Institute
Department

Funding Source
Organization	None
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
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	医療法人相生会　博多クリニック（福岡県）

Other administrative information
Date of disclosure of the study information	2016 Year 02 Month 12 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 02 Month 04 Day
Anticipated trial start date	2016 Year 02 Month 12 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results	Hyperglycemic state was maintained in all six subjects. Results of insulin and C-peptide indicated effectiveness of our methods to evaluate the first- and second- insulin secretory ability quantitatively. No AE including clinically significant decrease of Potassium was observed, and our methods were considered technically safe.
Other related information

Management information
Registered date	2016 Year 02 Month 09 Day
Last modified on	2017 Year 01 Month 26 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000024182