UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Effects of preprandial administration of high-dose metformin on postprandial hypertriglyceridemia.
Title of the study (Brief title)	Effects of preprandial administration of high-dose metformin on postprandial hypertriglyceridemia.
Region	Japan

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

Objectives
Narrative objectives1	To investigate the effects of metformin on changes in postprandial serum triglyceride concentrations between postprandial and preprandial administration.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Changes in postprandial serum triglyceride concentrations between postprandial and preprandial administration
Key secondary outcomes	Changes of following parameters between postprandial and preprandial administration 1) plasma glucose, plasma insulin, GLP-1 2) Visual analyzing score of gastrointestinal symptoms and satiety

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -but assessor(s) are blinded
Control	Active
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Central registration

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Oral administration of 500-1000 mg metformin before test meal
Interventions/Control_2	Oral administration of 500-1000 mg metformin after test meal
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	70 years-old >
Gender	Male and Female
Key inclusion criteria	1) Aged >= 20, <70 at consent 2) In-patients with type2 diabetes at shiga universuty hospital with 500-1000 mg per single dose of metformin 3) Random non-fasting Triglyceride > 150mg/dl and < 1000mg/dl 4) Provided written informed consent
Key exclusion criteria	1) Receiving drugs that affect gastrointestinal motility (Glucagon-like peptide-1 analogue, or anticholinergic drug, etc.) 2) Has history of pancreatitis 3) With severe autonomic dysfunction (orthostatic hypotension, or neurogenic bladder, etc.) 4) Has history of intestinal obstruction after upper gastrointestinal surgery or hepato-biliary-pancreatic surgery 5) Receiving treatment for cancers 6) During pregnancy or lactation 7) With contraindications to metformin (history of lactic acidosis, or moderate and severe renal impairment, etc.) 8) Considered inadequate by the investigator
Target sample size	10

Research contact person
Name of lead principal investigator	Katsutaro Morino
Organization	Shiga University of Medical Science
Division name	Department of Medicine, Division of Diabetes, Nephrology and Neurology
Address	Seta Tsukinowa-cho, Otsu-city, Shiga, Japan 520-2192
TEL	077-548-2222
Email	morino@belle.shiga-med.ac.jp

Public contact
Name of contact person	Katsutaro Morino
Organization	Shiga University of Medical Science
Division name	Department of Medicine, Division of Diabetes, Nephrology and Neurology
Address	Seta Tsukinowa-cho, Otsu-city, Shiga, Japan 520-2192
TEL	077-548-2222
Homepage URL	http://www.shiga-med.ac.jp/hospital/doc/department/department/secretion/index.html
Email	morino@belle.shiga-med.ac.jp

Sponsor
Institute	Shiga University of Medical Science
Institute
Department

Funding Source
Organization	Shiga University of Medical Science Management Expenses Grants
Organization
Division
Category of Funding Organization	Other
Nationality of Funding Organization	Japan

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	滋賀医科大学附属病院(滋賀県）

Other administrative information
Date of disclosure of the study information	2016 Year 06 Month 13 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2016 Year 03 Month 22 Day
Anticipated trial start date	2016 Year 06 Month 13 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
Other related information

Management information
Registered date	2016 Year 06 Month 11 Day
Last modified on	2018 Year 06 Month 28 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000026161