UMIN-CTR Clinical Trial

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
Email	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
Email	r-mitsuno-p-k@iuhw.ac.jp

Sponsor
Institute	International University of Health and Welfare
Institute
Department

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
Email	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000051644