CoQ10 Effects on MDM Liver Fat Via FibroTouchI.

NCT07748130 · tracked via the Priya Life Science China tracker

Sponsor

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

Phase

Not applicable

Started

2026-09

Last updated

2026-08-05

Condition(s) studied

Mitochondrial Diabetes

Investigational drug(s) / intervention(s)

Coenzyme Q10 (drug) →Only undergo baseline assessments without intervention.Only undergo baseline assessments without intervention.

Coenzyme Q10 (drug): 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.: Only undergo baseline assessments without intervention.

Study summary

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.

Eligibility

Sex

ALL

Min age

18 Years

Max age

70 Years

Healthy volunteers

Accepted

1\. Mitochondrial Diabetes Group Inclusion Criteria: 1. Confirmed as a carrier of the mitochondrial DNA m.3243A\>G mutation through genetic testing; 2. Meeting the diagnostic criteria for diabetes (WHO 1999 diagnostic criteria); 3. Aged between 18 and 70 years; 4. Willing to participate and having signed the informed consent form. Exclusion Criteria: 1. Type 1 or type 2 diabetes (not caused by mitochondrial gene mutations); 2. Comorbid with viral hepatitis, drug-induced hepatitis, alcoholic liver disease, Wilson's disease, or other specific diseases that can lead to fatty liver; 3. Severe cardiac, pulmonary, or renal insufficiency; 4. Pregnant or lactating women; 5. Having used coenzyme Q10 or other mitochondrial-targeted drugs within the past 3 months; 6. Having contraindications to MRI examination; 7. Having experienced infection, surgery, or major trauma within the past 4 weeks. Withdrawal/Dropout Criteria: 1. The subject withdraws informed consent; 2. The occurrence of serious adverse events; 3. Loss to follow-up; 4. Medication adherence that continued participation in \< 80%; 5. The researcher believes the study is not in the best interest of the subject. 2. Type 1 Diabetes Control Group Inclusion Criteria: 1. Meeting the diagnostic criteria for type 1 diabetes, with positive islet autoantibodies (GAD, IA-2, ICA, etc.); 2. Aged between 18 and 70 years; 3. 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: 1. No history of diabetes, with fasting blood glucose \< 5.6 mmol/L and HbA1c \< 5.7%; 2. Aged between 18 and 70 years; 3. 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.

Primary outcome measure(s)

Liver Fat Quantification — 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.

Trial sites (1)

Facility	City	Region	Status
The 95th hospital of Putian	Putian	Fujian

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Official registry record

This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.

View NCT07748130 on ClinicalTrials.gov ↗ ← All trials in China