UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000045209 |
|---|---|
| Receipt number | R000051644 |
| Scientific Title | Association of zinc deficiency and insulin resistance in hemodialysis patients using artificial pancreas |
| Date of disclosure of the study information | 2021/11/01 |
| Last modified on | 2021/08/20 17:09:15 |
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Basic information
Public title
Association of zinc deficiency and insulin resistance in hemodialysis patients using artificial pancreas
Acronym
AZIHAP
Scientific Title
Association of zinc deficiency and insulin resistance in hemodialysis patients using artificial pancreas
Scientific Title:Acronym
AZIHAP
Region
| Japan |
Condition
Condition
Zinc deficiency
Classification by specialty
| Medicine in general | Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Zinc deficiency, which is an essential trace element, causes symptoms such as dysgeusia, dermatitis, and anemia. In addition, zinc transporter is present in pancreatic beta cells, and zinc is said to be involved in insulin secretion. Furthermore, it is said to affect insulin resistance by enhancing the insulin receptor signal by being involved in the inhibition of dephosphorylation. In fact, it has been reported that supplementation with zinc in patients with metabolic syndrome with latent zinc deficiency improved HOMAR. There are various indicators of insulin resistance such as fasting blood insulin level and HOMAR, but the glucose clamp method is the golden standard, and the glucose clamp method should be performed accurately and easily by using an artificial pancreas. Approximately half of dialysis patients are considered to have zinc deficiency, but there is no report on the insulin resistance of zinc deficiency dialysis patients, and this will be clarified by the glucose clamp method using an artificial pancreas.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Hemodialyzed patients with zinc deficiency and latent zinc deficiency are supplemented with zinc for 6 weeks and insulin resistance is assessed by glucose clamp before and after that.
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Single arm
Randomization
Non-randomized
Randomization unit
Blinding
Open -no one is blinded
Control
Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
1
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Hemodialyzed patients with zinc deficiency and latent zinc deficiency are supplemented with zinc 50 mg / dL for 6 weeks, and insulin resistance is evaluated by the glucose clamp method before and after that.
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
| 30 | years-old | <= |
Age-upper limit
| 100 | years-old | >= |
Gender
Male
Key inclusion criteria
Patients on hemodialysis who have zinc deficiency and latent zinc deficiency.
Key exclusion criteria
Patients with zinc deficiency and latent zinc deficiency
Target sample size
10
Research contact person
Name of lead principal investigator
| 1st name | Naoki |
| Middle name | |
| Last name | Washida |
Organization
International University of Health and Welfare, Narita Hospital
Division name
Department of Nephrology
Zip code
286-8520
Address
Narita, Japan
TEL
0476355600
washida@iuhw.ac.jp
Public contact
Name of contact person
| 1st name | Ryunosuke |
| Middle name | |
| Last name | Mitsuno |
Organization
International University of Health and Welfare, Narita Hospital
Division name
Department of Nephrology
Zip code
286-8520
Address
Narita, Japan
TEL
0476355600
Homepage URL
r-mitsuno-p-k@iuhw.ac.jp
Sponsor or person
Institute
International University of Health and Welfare
Institute
Department
Personal name
Funding Source
Organization
International University of Health and Welfare
Organization
Division
Category of Funding Organization
Other
Nationality of Funding Organization
Other related organizations
Co-sponsor
Name of secondary funder(s)
IRB Contact (For public release)
Organization
International University of Health and Welfare
Address
Narita, Japan
Tel
0476355600
r-mitsuno-p-k@iuhw.ac.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
Other administrative information
Date of disclosure of the study information
| 2021 | Year | 11 | Month | 01 | 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
Preinitiation
Date of protocol fixation
| 2021 | Year | 08 | Month | 20 | Day |
Date of IRB
Anticipated trial start date
| 2021 | Year | 11 | Month | 01 | Day |
Last follow-up date
| 2022 | Year | 01 | Month | 31 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2021 | Year | 08 | Month | 20 | Day |
Last modified on
| 2021 | Year | 08 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051644
