UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000020549 |
|---|---|
| Receipt number | 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 11:48:12 |
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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
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
kuni-s@dokkyomed.ac.jp
Sponsor or person
Institute
Department of Endocrinology and Metabolism, Dokkyo Medical University
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000023588
