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NCT Number: NCT07748130

CoQ10 Effects on MDM Liver Fat Via FibroTouchI.

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.

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Key information

Age range

18 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

The 95th hospital of Putian

Putian, Fujian, 351100, China

Location contact

The Scientific Research and Education Department

CONTACT

[email protected]

+8618760590880

About this study

  • Research Materials Coenzyme Q10: Utilize Coenzyme Q10 formulations that comply with Good Manufacturing Practice (GMP) standards (e.g., Bio-Quinone or equivalent quality products), with each capsule containing 100 mg of Coenzyme Q10 and excipients such as soybean oil and beeswax.

Control Medication: None.

  • Treatment Protocols Mitochondrial Diabetes Group: On the basis of maintaining the original hypoglycemic treatment regimen (primarily insulin, avoiding metformin), add Coenzyme Q10 at a dose of 100 mg three times daily (total dose of 300 mg/day) for 12 consecutive weeks.

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

  • Mitochondrial Diabetes Group

Inclusion criteria

  • 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.

Exclusion criteria

  • 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.

Treatment and study plan

Coenzyme Q10 (drug)

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.

Other

Only undergo baseline assessments without intervention.

Primary outcomes

  1. Liver Fat Quantification

    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.

Secondary outcomes

  1. Blood biochemistry indicators

    Time frame: From enrollment to the end of treatment at 12 weeks

    • Liver Function Tests (LFTs) Includes: Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), Albumin (ALB), Total bilirubin (TBIL), etc.
    • Kidney Function Tests Includes: Blood urea nitrogen (BUN), Creatinine (Cr), Estimated glomerular filtration rate (eGFR), etc.
    • Lipid Panel Includes (TG), High-density lipoprotein cholesterol (HDL-C), Low-density lipoprotein cholesterol (LDL-C), etc.
    • Glucose Metabolism Markers Includes: Fasting blood glucose (FBG), Oral glucose tolerance test (OGTT), Glycated hemoglobin (HbA1c), etc.
    • Pancreatic Islet Function Tests Includes: Fasting insulin, C-peptide, Glucose-stimulated insulin secretion test (e.g., after OGTT), etc.

Other outcomes

  1. Anthropometric Indicators

    Time frame: From enrollment to the end of treatment at 12 weeks

    Body Mass Index (BMI) = Weight (kg) / Height (m)²

Study contacts

Contact information is provided by the study sponsor or research team.

Sponsors and collaborators

Lead sponsor

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

Other

Registry information

Official study title

The Effect of Coenzyme Q10 on Quantitative Changes in Hepatic Fat in Patients With Mitochondrial Diabetes

Important dates

Study start
2026
Primary completion
2027
Study completion
2027
First posted
Aug 5, 2026
Registry last updated
Aug 5, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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