UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	A Crossover Study to Assess the 2 Glucose Tolerance Tests on Incretin, Beta-cell function and Insulin Sensitivity in Japanese Healthy and Type 2 Diabetes Subjects
Title of the study (Brief title)	Two Glucose Tolerance Tests on Incretin, beta-cell function and Insulin Sensitivity in Japanese T2DM Patients
Region	Japan

Condition
Condition	T2DM
Classification by specialty	Endocrinology and Metabolism
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To assess effects of two glucose tolerance (75g OGTT and mixed meal) on incretin, beta cell function and insulin sensitivity in Japanese T2DM and healthy volunteers.
Basic objectives2	Others
Basic objectives -Others	To assess correlation between incretin and beta cell function.
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	To assess effects of two glucose tolerance tests (75g OGTT and mixed meal) on following parameters in Japanese T2DM and healthy volunteers; 1) Changes in plasma glucose levels 2) Changes in serum insulin and C-peptide levels 3) Changes in plasma glucagon levels 4) Changes in plasma GIP (total, intact) levels 5) Changes in plasma GLP-1 (total, intact) levels
Key secondary outcomes

Base
Study type	Interventional

Study design
Basic design	Cross-over
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Pseudo-randomization

Intervention
No. of arms	2
Purpose of intervention	Diagnosis
Type of intervention	Other
Interventions/Control_1	75g OGTT
Interventions/Control_2	Mixed 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	65 years-old >=
Gender	Male
Key inclusion criteria	(Healthy volunteers) - free from any disease at screening - fasting plasma glucose less than 110 mg/dL at screening - BMI<27kg/m2 (T2DM volunteers) - Previous diagnosis of T2DM - No anti-diabetic medication - HbA1c (JDS) <7.5 at screening - BMI<27kg/m2
Key exclusion criteria	1) Patients with diabetes requiring insulin therapy (insulin intensive therapy, T1DM, etc) 2) Patients treated with any anti-diabetic drugs 3) Patients with heart disease 4) Patients with renal dysfunction 5) Patients with severe hepatic dysfunction 6) Patients with history of pancreatitis 7) Patients with a history of surgery of gastrointestinal tract 8) Patients with malignant tumor(s) 9) Patients with severe infection, in the perioperative period or with serious injury 10) Excessive alcohol intake or drug abuse 11) Patients found ineligible as a study patient according to the discretion of the investigator or sub-investigator 12)Pregnant or possibly pregnant women
Target sample size	32

Research contact person
Name of lead principal investigator	Yutaka Seino
Organization	Kansai Electric Power Hospital
Division name	Center for Diabetes, Endocrinology and Metabolism
Address	2-1-7 Fukushima, Fukushima-ku, Osaka, Japan
TEL	+81-6-6458-5821
Email	seino.yutaka@e2.kepco.co.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, Fukushima-ku, Osaka, Japan
TEL	+81-6-6458-5821
Homepage URL
Email	ydaisuke-kyoto@umin.ac.jp

Sponsor
Institute	Kansai Electric Power Hospital
Institute
Department

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

Other related organizations
Co-sponsor	Department of Diabetes and Clinical Nutrition, Kyoto University Graduate School of Medicine Department of Diabetes, Metabolism and Endocrinology, Showa University School of Medicine Center for Advanced Medicine and Clinical Research, Nagoya University Hospital Department of Biomedical Sciences, University of Copenhagen
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	関西電力病院（大阪府）/ Kansai Electric Power Hospital (Osaka) 京都大学大学院医学研究科 糖尿病・栄養内科（京都府）/ Department of Diabetes and Clinical Nutrition, Kyoto University Graduate School of Medicine (Kyoto) 昭和大学医学部 糖尿病・代謝・内分泌内科（東京都）/ Department of Diabetes, Metabolism and Endocrinology, Showa University School of Medicine (Tokyo)

Other administrative information
Date of disclosure of the study information	2014 Year 07 Month 16 Day

Progress
Recruitment status	Completed
Date of protocol fixation	2007 Year 09 Month 30 Day
Anticipated trial start date	2007 Year 11 Month 01 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	Published
URL releasing results	http://www.jdcjournal.com/article/S1056-8727(14)00407-3/pdf
Results	Hypersecretion of glucagon and reduced insulin secretion both contribute to hyperglycemia in type 2 diabetes (T2DM). However, the relative contributions of impaired glucagon and insulin secretions in glucose excursions at the various stages of T2DM development remain to be determined. In OGTT, T2DM showed a rise in glucagon at 0-30min, unlike NGT and IGT, along with reduced insulin. In MTT, all three groups showed a rise in glucagon at 0-30min, with that in T2DM being highest, while T2DM showed a significant reduction in insulin. Linear regression analyses revealed that glucose area under the curve (AUC)0-120 min was associated with glucagon-AUC0-30 min and insulin-AUC0-30 min in both OGTT and MTT. Total and biologically intact GIP and GLP-1 levels were similar among the three groups. Disordered early phase insulin and glucagon secretions but not incretin secretion are involved in hyperglycemia after ingestion of nutrients in T2DM of even a short duration.
Other related information

Management information
Registered date	2014 Year 07 Month 16 Day
Last modified on	2016 Year 12 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016954