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Name:
UMIN ID:

Recruitment status Preinitiation
Unique ID issued by UMIN UMIN000040581
Receipt No. R000046223
Scientific Title A single-arm, open-label, intervention study to investigate the improvement of glucose tolerance after administration of the 5-aminolevulinic acid (5-ALA) in the patients with mitochondrial diabetes mellitus
Date of disclosure of the study information 2020/07/01
Last modified on 2020/05/29

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Basic information
Public title A single-arm, open-label, intervention study to investigate the improvement of glucose tolerance after administration of the 5-aminolevulinic acid (5-ALA) in the patients with mitochondrial diabetes mellitus
Acronym 5-ALA study of mitochondrial diabetes mellitus
Scientific Title A single-arm, open-label, intervention study to investigate the improvement of glucose tolerance after administration of the 5-aminolevulinic acid (5-ALA) in the patients with mitochondrial diabetes mellitus
Scientific Title:Acronym 5-ALA study of mitochondrial diabetes mellitus
Region
Japan

Condition
Condition Mitochondrial diabetes mellitus
Classification by specialty
Endocrinology and Metabolism
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate whether additional administration of 5-aminolevulinic acid/sodium ferrous citrate (5-ALA/SFC) to the patients with mitochondrial diabetes mellitus improves their glycemic control.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Changes of AUC of IRI during 75gOGTT after administration of 5-ALA/SFC for 24 weeks.
Key secondary outcomes Changes in the following items after administration of 5-ALA/SFC for 24 weeks; fasting blood glucose, glycated hemoglobin level, glycated albumin level, some values in 75gOGTT, and required amount of daily insulin treatment.

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 Patients with mitochondrial diabetes mellitus receive an additional 24 weeks of 5-ALA/SFC.
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 1. Patient aged 20 years or older.
2. Outpatient.
3. Patients who meet all of the following main criteria and one of the sub-criteria.
[main criteria]
a. Patients with diabetes mellitus treated with insulin or clinically required insulin therapy for glycemic control due to the insulin secretory defect.
b. Patients complicated with neurosensory deafness.
[sub-criteria]
a. Patients who have a family history of maternally inherited diabetes mellitus.
b. Patients whose serum lactate level or lactate/pyruvate ratio are high at bed rest.
c. Patients with short stature.
d. Patients complicated with cardiomyopathy or cardiac conduction abnormality.
e. Patients whose basal-ganglia and brainstem have bilaterally symmetric abnormal lesions on CT/MRI.
4. Patients who have not changed the drug or dose of antidiabetic agents except insulin for 8 weeks until obtaining informed consent.
5. Written informed consent.
Key exclusion criteria 1. Patients who have previously taken 5-ALA/SFC within 8 weeks.
2. Patients treated with metformin.
3. Patients with a history of porphyria, hemochromatosis, or viral hepatitis.
4. Women who are currently pregnant or will not be compliant with a medically approved contraceptive regimen during the study period and lactating women. Men who will not be compliant with a contraceptive regimen during the study period.
5. Patients participated in another clinical study within 4 months.
6. Patients whom the investigator considered inappropriate to participating this trial.
Target sample size 5

Research contact person
Name of lead principal investigator
1st name Norio
Middle name
Last name Abiru
Organization Nagasaki University Hospital
Division name Department of Endocrinology and Metabolism
Zip code 8528501
Address 1-7-1 Sakamoto, Nagasaki
TEL 0958197262
Email abirun@nagasaki-u.ac.jp

Public contact
Name of contact person
1st name Norio
Middle name
Last name Abiru
Organization Nagasaki University Hospital
Division name Department of Endocrinology and Metabolism
Zip code 8528501
Address 1-7-1 Sakamoto, Nagasaki
TEL 0958197262
Homepage URL
Email abirun@nagasaki-u.ac.jp

Sponsor
Institute Nagasaki University Hospital
Institute
Department

Funding Source
Organization Neopharama Japan Co.LTD
Organization
Division
Category of Funding Organization Profit organization
Nationality of Funding Organization

Other related organizations
Co-sponsor
Name of secondary funder(s)

IRB Contact (For public release)
Organization Nagasaki University Clinical Research Review Board
Address 1-7-1 Sakamoto, Nagasaki
Tel 0958197726
Email gaibushikin@ml.nagasaki-u.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
2020 Year 07 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
2020 Year 06 Month 30 Day
Date of IRB
Anticipated trial start date
2020 Year 06 Month 30 Day
Last follow-up date
2023 Year 06 Month 30 Day
Date of closure to data entry
Date trial data considered complete
Date analysis concluded

Other
Other related information

Management information
Registered date
2020 Year 05 Month 29 Day
Last modified on
2020 Year 05 Month 29 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046223

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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