UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000025662 |
|---|---|
| Receipt number | R000029522 |
| Scientific Title | Study of hepatic insulin resistance measured using fasting 13C-glucose breath test in patients with ischemic heart disease. |
| Date of disclosure of the study information | 2017/01/17 |
| Last modified on | 2020/01/17 15:59:32 |
* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments
Basic information
Public title
Study of hepatic insulin resistance measured using fasting 13C-glucose breath test in patients with ischemic heart disease.
Acronym
Effects of hepatic insulin resistance on ischemic heart disease.
Scientific Title
Study of hepatic insulin resistance measured using fasting 13C-glucose breath test in patients with ischemic heart disease.
Scientific Title:Acronym
Effects of hepatic insulin resistance on ischemic heart disease.
Region
| Japan |
Condition
Condition
Ischemic heart disease
Classification by specialty
| Medicine in general | Cardiology | Endocrinology and Metabolism |
| Laboratory medicine |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To examine the relationship between hepatic insulin resistance and pathogenesis of ischemic heart disease.
Basic objectives2
Others
Basic objectives -Others
To explore novel risk factors for the diseases
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Hepatic insulin resistance measured using the fasting 13C-glucose breath test; 13C excretion rate at 2 hours.
Key secondary outcomes
Insulin resistance calculated using HOMA-IR,
High density lipoprotein(HDL) function, the relationship between 13C excretion rate and HDL function, and Blood analyses including Hemoglobin A1c levels, Plasma glucose levels, Immunoreactive insulin levels, Lipid profile,
Markers indicating obesity (e.g. adiponectin), inflammation (high sensitive CRP), oxidative stress (8-OHdG/ MDA-LDL), etc.
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
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
| 85 | years-old | > |
Gender
Male and Female
Key inclusion criteria
1) Patients with ischemic heart disease who have significant stenotic lesions on coronary arteries.
2) Patients with heart disease without ischemic heart disease.
3) Healthy volunteers without heart disease.
4) Patients who gave written informed consent
Key exclusion criteria
1) Less than 20 years old, 85 years old or older.
2) Acute coronary syndrome
3) End-stage renal disease (eGFR<30 ml/min) including patients under hemodialysis
4) Type1 diabetes mellitus
5) Subjects who are pregnant or possible to be pregnant
6) Shock
7) Subjects who are planned to have surgical operation or endoscopic therapy in 3 months which needs to stop antiplatelet therapy
8) Subjects whose doctor in charge do not agree to join the trial
Target sample size
200
Research contact person
Name of lead principal investigator
| 1st name | Masami |
| Middle name | |
| Last name | Sakurada |
Organization
Tokorozawa Heart Center
Division name
Department of Cardiology
Zip code
359-1142
Address
2-61-11 Kamiarai, Tokorozawa, Saitama, JAPAN 359-1142
TEL
04-2940-8611
ayaori@ba2.so-net.ne.jp
Public contact
Name of contact person
| 1st name | Hirotaka |
| Middle name | |
| Last name | Ezaki |
Organization
Tokorozawa Heart Center
Division name
Department of Cardiology
Zip code
359-1142
Address
2-61-11 Kamiarai, Tokorozawa, Saitama, JAPAN 359-1142
TEL
04-2940-8611
Homepage URL
hirotakaezaki@gmail.com
Sponsor or person
Institute
Tokorozawa Heart Center
Institute
Department
Personal name
Funding Source
Organization
Foundation for Promotion of Defense Medicine
Organization
Division
Category of Funding Organization
Non profit foundation
Nationality of Funding Organization
Japan
Other related organizations
Co-sponsor
1) The Jikei University School of Medicine, the Department of Laboratory Medicine.
2) National Defense Medical Collage, the Division of Anti-aging, Department of Internal Medicine.
Name of secondary funder(s)
The Jikei University School of Medicine, the Department of Laboratory Medicine.
IRB Contact (For public release)
Organization
The Ethics Committee of Tokorozawa Heart Center
Address
2-61-11 Kamiarai, Tokorozawa, Saitama, JAPAN 359-1142
Tel
04-2940-8611
cs.thc@oukai.or.jp
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
所沢ハートセンター
防衛医科大学校病院
東京慈恵会医科大学
Other administrative information
Date of disclosure of the study information
| 2017 | Year | 01 | Month | 17 | Day |
Related information
URL releasing protocol
Publication of results
Published
Result
URL related to results and publications
Number of participants that the trial has enrolled
200
Results
The value of C120 in each disease group was significantly lower than in HV, but the HOMA-IR in the IHD and NCD groups was not significantly different from that in HV. The value of C120 significantly correlated with known cardiovascular risk factors.
These results indicated the FGBT is more sensitive than HOMA-IR for evaluating hepatic IR as a cardiovascular risk factor and is likely useful for managing patients to prevent cardiovascular disease.
Results date posted
| 2020 | Year | 01 | Month | 17 | Day |
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
Main results already published
Date of protocol fixation
| 2016 | Year | 09 | Month | 16 | Day |
Date of IRB
| 2016 | Year | 01 | Month | 18 | Day |
Anticipated trial start date
| 2017 | Year | 01 | Month | 17 | Day |
Last follow-up date
| 2020 | Year | 01 | Month | 16 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Objective;
100 patients with ischemic heart disease, 50 patients with non-ischemic heart disease (arrhythmia, dilated cardiomyopathy, or so on) and 50 healthy volunteer. Patients who gave written informed consent.
Measurements;
13C excretion rate at 2hours using the fasting 13C-glucose breath test, HDL function (the ability of cholesterol efflux, antioxidant effects, anti-inflammatory effects, endothelial function), and Blood analyses including Hemoglobin A1c levels, Plasma glucose levels, Immunoreactive insulin levels, Lipid profile,
Markers indicating obesity (e.g. adiponectin), inflammation (high sensitive CRP), oxidative stress (8-OHdG/ MDA-LDL), etc.
Management information
Registered date
| 2017 | Year | 01 | Month | 13 | Day |
Last modified on
| 2020 | Year | 01 | Month | 17 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000029522
| Research Plan | |
|---|---|
| Registered date | File name |
| Research case data specifications | |
|---|---|
| Registered date | File name |
| Research case data | |
|---|---|
| Registered date | File name |
