UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000014575 |
|---|---|
| Receipt number | 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 09:35:07 |
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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
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
seino.yutaka@e2.kepco.co.jp
Public contact
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
ydaisuke-kyoto@umin.ac.jp
Sponsor or person
Institute
Kansai Electric Power Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000016954
