Unique ID issued by UMIN | UMIN000040581 |
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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 |
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
5-ALA study of mitochondrial diabetes mellitus
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
5-ALA study of mitochondrial diabetes mellitus
Japan |
Mitochondrial diabetes mellitus
Endocrinology and Metabolism |
Others
NO
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.
Efficacy
Changes of AUC of IRI during 75gOGTT after administration of 5-ALA/SFC for 24 weeks.
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.
Interventional
Single arm
Non-randomized
Open -no one is blinded
Uncontrolled
1
Treatment
Medicine |
Patients with mitochondrial diabetes mellitus receive an additional 24 weeks of 5-ALA/SFC.
20 | years-old | <= |
Not applicable |
Male and Female
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.
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.
5
1st name | Yuta |
Middle name | |
Last name | Nakamura |
Nagasaki University Hospital
Department of Endocrinology and Metabolism
8528501
1-7-1 Sakamoto, Nagasaki
0958197262
y.nakamura@nagasaki-u.ac.jp
1st name | Yuta |
Middle name | |
Last name | Nakamura |
Nagasaki University Hospital
Department of Endocrinology and Metabolism
8528501
1-7-1 Sakamoto, Nagasaki
0958197262
y.nakamura@nagasaki-u.ac.jp
Nagasaki University Hospital
Neopharama Japan Co.LTD
Profit organization
Nagasaki University Clinical Research Review Board
1-7-1 Sakamoto, Nagasaki
0958197726
gaibushikin@ml.nagasaki-u.ac.jp
NO
2020 | Year | 07 | Month | 01 | Day |
htps://doi.org/10.1097/MD.0000000000025100
Published
https://doi.org/10.1007/s13300-022-01335-8
5
Completed
2020 | Year | 06 | Month | 30 | Day |
2020 | Year | 06 | Month | 24 | Day |
2020 | Year | 06 | Month | 30 | Day |
2023 | Year | 06 | Month | 30 | Day |
2020 | Year | 05 | Month | 29 | Day |
2023 | Year | 07 | Month | 28 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000046223
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