The 95th hospital of Putian
Putian, Fujian, 351100, China
NCT Number: NCT07748130
Mitochondrial diabetes mellitus (MDM) is a rare subtype of diabetes caused by mitochondrial dysfunction, often accompanied by hepatic steatosis. Coenzyme Q10 (CoQ10), a key electron carrier and antioxidant, may improve mitochondrial function and lipid metabolism. This prospective study aims to evaluate the effect of 12-week CoQ10 supplementation (300 mg/day) on liver fat content (assessed by FibroTouch CAP ) in MDM patients with m.3243A>G mutation. An exploratory case-control design will compare baseline characteristics among MDM patients, type 1 diabetes patients, and healthy controls. This study is the first to explore the link between mitochondrial defects and hepatic fat accumulation specifically in MDM, and to test CoQ10 as a potential therapy, offering new insights for both MDM and MAFLD management.
Trial opening soon.
Get Notified18 year–70 year
All sexes
Interventional
Not applicable
Putian, Fujian, 351100, China
Control Medication: None.
Type 1 Diabetes Control Group and Healthy Control Group: Only undergo baseline assessments without intervention.
Concomitant Medication Regulations:
Maintain the patient's original hypoglycemic treatment regimen unchanged. Avoid using medications that may affect mitochondrial function (e.g., minimize or switch metformin and statins if possible).
Do not add other medications or supplements with antioxidant or mitochondrial protective effects during the study period.
If adjustments to hypoglycemic medications are necessary due to clinical conditions, record the medication name, dosage, and reasons for adjustment in detail.
Healthy volunteers accepted: Yes
Only the study team can determine whether someone qualifies for participation.
Inclusion criteria
Exclusion criteria
Withdrawal/Dropout Criteria:
Inclusion criteria
Exclusion criteria
Same as the exclusion criteria (1) to (7) for the mitochondrial diabetes group. 3. Healthy Adult Control Group
Inclusion criteria
Exclusion criteria
Same as the exclusion criteria (1) to (7) for the mitochondrial diabetes group.
This prospective study aims to evaluate the effect of 12 week CoQ10 supplementation (300 mg/day) on liver fat content (assessed by FibroTouch CAP) in MDM patients with m.3243A>G mutation. An exploratory case control design will compare baseline characteristics among MDM patients, type 1 diabetes patients, and healthy controls.
Only undergo baseline assessments without intervention.
Time frame: From enrollment to the end of treatment at 12 weeks
The degree of hepatic fat deposition is assessed using the Controlled Attenuation Parameter (CAP) value measured by FibroTouch ultrasound imaging. The CAP value, expressed in dB/m, indicates the severity of hepatic steatosis, with higher values reflecting more advanced fat accumulation in the live.
Time frame: From enrollment to the end of treatment at 12 weeks
Time frame: From enrollment to the end of treatment at 12 weeks
Body Mass Index (BMI) = Weight (kg) / Height (m)²
Contact information is provided by the study sponsor or research team.
Jing Lin
CONTACT
Xuebai Chen
CONTACT
The 95th Hospital of Putian,Putian, Fujian, China
Other
The Effect of Coenzyme Q10 on Quantitative Changes in Hepatic Fat in Patients With Mitochondrial Diabetes
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