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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000020549
Receipt No. R000023588
Scientific Title Clinical implications of plasma hydrogen sulphide level in in Japanese people with type 2 diabete
Date of disclosure of the study information 2016/01/13
Last modified on 2016/01/04

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Basic information
Public title Clinical implications of plasma hydrogen sulphide level in in Japanese people with type 2 diabete
Acronym Hydrogen Sulfide in type 2 diabetes
Scientific Title Clinical implications of plasma hydrogen sulphide level in in Japanese people with type 2 diabete
Scientific Title:Acronym Hydrogen Sulfide in type 2 diabetes
Region
Japan

Condition
Condition patients with type 2 diabetes and patients without diabetes
Classification by specialty
Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The goal of the present study was to investigate plasma hydrogen sulfide (H2S) levels in patients with type 2 diabetes. The plasma H2S levels in Japanese patients with type 2 diabetes remain unclear.
Basic objectives2 Others
Basic objectives -Others the purpose of this study was to examine plasma H2S levels in patients with type 2 diabetes and its relevance to the glycemic control state and the history of cardiovascular disease in these patients.
Trial characteristics_1 Exploratory
Trial characteristics_2 Others
Developmental phase Not applicable

Assessment
Primary outcomes plasma H2S levels in patients with type 2 diabetes
Key secondary outcomes The relevance between plasma H2S levels and the history of cardiovascular disease

The relevance between plasma H2S levels and the glycemic control

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

Not applicable
Gender Male and Female
Key inclusion criteria This randomized study included randomly selected 200 patients with type 2 diabetes and 100 patients without diabetes from the outpatients who had visited this institution for type 2 diabetes and 308 outpatients without diabetes who had visited for hypertension, dyslipidemia, or thyroid disease controlled satisfactorily by medication.
Key exclusion criteria 1) severe ketosis and diabetic coma, 2) severe complication of diabetes, 3) renal insufficiency (serum creatinine level >1.5 mg/dL in men or >1.3 mg/dL in women) and liver dysfunction, 4) severe infection, 5) pregnant or nursing women and those who might be pregnant, 6) alcoholism, and 7) any patients whom the investigators judged to be inappropriate for this study.
Target sample size 300

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Kunihiro Suzuki
Organization Dokkyo Medical University
Division name Department of Endocrinology and Metabolism
Zip code
Address 880 Kitakobayashi, Mibu, Simotsugagun, Tochigi
TEL 0282-86-1111
Email kuni-s@dokkyomed.ac.jp

Public contact
Name of contact person
1st name
Middle name
Last name Kunihiro Suzuki
Organization Dokkyo Medical University
Division name Department of Endocrinology and Metabolism
Zip code
Address 880 Kitakobayashi, Mibu, Simotsugagun, Tochigi
TEL 0282-86-1111
Homepage URL
Email kuni-s@dokkyomed.ac.jp

Sponsor
Institute Department of Endocrinology and Metabolism, Dokkyo Medical University
Institute
Department

Funding Source
Organization Department of Endocrinology and Metabolism, Dokkyo Medical University
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor
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

Other administrative information
Date of disclosure of the study information
2016 Year 01 Month 13 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 Completed
Date of protocol fixation
2015 Year 01 Month 01 Day
Date of IRB
Anticipated trial start date
2015 Year 01 Month 04 Day
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information This pilot, randomized study included randomly selected 200 patients with type 2 diabetes and 100 patients without diabetes from the 626 outpatients who had visited this institution for type 2 diabetes and 308 outpatients without diabetes who had visited for hypertension, dyslipidemia, or thyroid disease controlled satisfactorily by medication.

Management information
Registered date
2016 Year 01 Month 13 Day
Last modified on
2016 Year 01 Month 04 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023588

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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