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
Not Applicable
- Conditions
- Mitochondrial diabetes mellitus
- Registration Number
- JPRN-UMIN000040581
- Lead Sponsor
- agasaki University Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 5
Inclusion Criteria
Not provided
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Changes of AUC of IRI during 75gOGTT after administration of 5-ALA/SFC for 24 weeks.
- Secondary Outcome Measures
Name Time Method 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.