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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000014575
Receipt No. R000016954
Scientific Title 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
Date of disclosure of the study information 2014/07/16
Last modified on 2016/12/09

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Basic information
Public title 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
Acronym Two Glucose Tolerance Tests on Incretin, beta-cell function and Insulin Sensitivity in Japanese T2DM Patients
Scientific Title 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
Scientific Title:Acronym 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
Last name of lead principal investigator
1st name
Middle name
Last name Yutaka Seino
Organization Kansai Electric Power Hospital
Division name Center for Diabetes, Endocrinology and Metabolism
Zip code
Address 2-1-7 Fukushima, Fukushima-ku, Osaka, Japan
TEL +81-6-6458-5821
Email seino.yutaka@e2.kepco.co.jp

Public contact
1st name of contact person
1st name
Middle name
Last name Daisuke Yabe
Organization Kansai Electric Power Hospital
Division name Center for Diabetes, Endocrinology and Metabolism
Zip code
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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Related information
URL releasing protocol
Publication of results Published

Result
URL related to results and publications http://www.jdcjournal.com/article/S1056-8727(14)00407-3/pdf
Number of participants that the trial has enrolled
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.
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 Completed
Date of protocol fixation
2007 Year 09 Month 30 Day
Date of IRB
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

Other
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

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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