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

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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

JPRN

Registry ID

JPRN-UMIN000040581

Enrollment

Registered

2020-07-01

Start date

2020-06-30

Completion date

Unknown

Last updated

2026-06-29

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Mitochondrial diabetes mellitus

Interventions

Patients with mitochondrial diabetes mellitus receive an additional 24 weeks of 5-ALA/SFC.

Eligibility

Sex/Gender

All

Inclusion criteria

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.

Exclusion criteria

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.

Design outcomes

Primary

Measure	Time frame
Changes of AUC of IRI during 75gOGTT after administration of 5-ALA/SFC for 24 weeks.	—

Secondary

Measure	Time frame
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.	—

Countries

Japan

Contacts

Public ContactYuta Nakamura

Nagasaki University Hospital Department of Endocrinology and Metabolism

y.nakamura@nagasaki-u.ac.jp0958197262

Outcome results

None listed

Source: JPRN (via WHO ICTRP) · Data processed: Jul 3, 2026