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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000025662
Receipt No. 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 2018/10/10

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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
Middle name
Last name Masami Sakurada
Organization Tokorozawa Heart Center
Division name Department of Cardiology
Zip code
Address 2-61-11 Kamiarai, Tokorozawa, Saitama, JAPAN 359-1142
TEL 04-2940-8611
Email ayaori@ba2.so-net.ne.jp

Public contact
Name of contact person
1st name
Middle name
Last name Hirotaka Ezaki
Organization Tokorozawa Heart Center
Division name Department of Cardiology
Zip code
Address 2-61-11 Kamiarai, Tokorozawa, Saitama, JAPAN 359-1142
TEL 04-2940-8611
Homepage URL
Email hirotakaezaki@gmail.com

Sponsor
Institute Tokorozawa Heart Center
Institute
Department

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
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 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 Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
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 No longer recruiting
Date of protocol fixation
2016 Year 09 Month 16 Day
Date of IRB
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
2018 Year 10 Month 10 Day


Link to view the page
URL(English) https://upload.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


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