CoQ10 Effects on MDM Liver Fat Via FibroTouchI.

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Conditions studied: Mitochondrial Diabetes

In brief

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.

Key facts

Study ID

NCT07748130

Run by

The 95th Hospital of Putian，Putian, Fujian, China

People needed

30

Starts

2026-09-01

Expected to finish

2027-12-01

Last updated by the study team

2026-08-05

Who can join

Age: 18 and older, up to 70. Sex: any. Healthy volunteers: accepted.

You may qualify if…

• Confirmed as a carrier of the mitochondrial DNA m.3243A>G mutation through genetic testing;
• Meeting the diagnostic criteria for diabetes (WHO 1999 diagnostic criteria);
• Aged between 18 and 70 years;
• Willing to participate and having signed the informed consent form.

You may not qualify if…

• Type 1 or type 2 diabetes (not caused by mitochondrial gene mutations);
• Comorbid with viral hepatitis, drug-induced hepatitis, alcoholic liver disease, Wilson's disease, or other specific diseases that can lead to fatty liver;
• Severe cardiac, pulmonary, or renal insufficiency;
• Pregnant or lactating women;
• Having used coenzyme Q10 or other mitochondrial-targeted drugs within the past 3 months;
• Having contraindications to MRI examination;
• Having experienced infection, surgery, or major trauma within the past 4 weeks.
• Withdrawal/Dropout Criteria:
• The subject withdraws informed consent;
• The occurrence of serious adverse events;
• Loss to follow-up;
• Medication adherence that continued participation in < 80%;
• The researcher believes the study is not in the best interest of the subject. 2. Type 1 Diabetes Control Group
• Inclusion Criteria:
• Meeting the diagnostic criteria for type 1 diabetes, with positive islet autoantibodies (GAD, IA-2, ICA, etc.);
• Aged between 18 and 70 years;
• Willing to participate and having signed the informed consent form.
• Exclusion Criteria:
• Same as the exclusion criteria (1) to (7) for the mitochondrial diabetes group. 3. Healthy Adult Control Group
• Inclusion Criteria:
• No history of diabetes, with fasting blood glucose < 5.6 mmol/L and HbA1c < 5.7%;
• Aged between 18 and 70 years;
• Willing to participate and having signed the informed consent form.
• Exclusion Criteria:
• Same as the exclusion criteria (1) to (7) for the mitochondrial diabetes group.

Where it is running

• The 95th hospital of Putian — Putian, Fujian, China

Full record on ClinicalTrials.gov

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