UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000040581
Receipt number 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 2023/07/28 08:44:21

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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 Yuta
Middle name
Last name Nakamura

Organization

Nagasaki University Hospital

Division name

Department of Endocrinology and Metabolism

Zip code

8528501

Address

1-7-1 Sakamoto, Nagasaki

TEL

0958197262

Email

y.nakamura@nagasaki-u.ac.jp


Public contact

Name of contact person

1st name Yuta
Middle name
Last name Nakamura

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

y.nakamura@nagasaki-u.ac.jp


Sponsor or person

Institute

Nagasaki University Hospital

Institute

Department

Personal name



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

htps://doi.org/10.1097/MD.0000000000025100

Publication of results

Published


Result

URL related to results and publications

https://doi.org/10.1007/s13300-022-01335-8

Number of participants that the trial has enrolled

5

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

2020 Year 06 Month 30 Day

Date of IRB

2020 Year 06 Month 24 Day

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

2023 Year 07 Month 28 Day



Link to view the page

Value
https://center6.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