CoQ10 Effects on MDM Liver Fat Via FibroTouchI.

ConditionMitochondrial Diabetes

Trial statusNot yet recruiting

Trial phaseNot applicable

Trial typeInterventional

Biological sexAll

Age18-70

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

About this trial

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 criteria

This trial accepts healthy volunteers

Qualifiers

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.

Disqualifiers

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;

Trial design

Design model

Parallel

Treatments tested in this trial

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 intervention
Only undergo baseline assessments without intervention.
Only undergo baseline assessments without intervention.
Other intervention
Only undergo baseline assessments without intervention.

Treatment groups

30 Participants

are divided into 3 treatment groups

Group A: Mitochondrial Disease Experimental GroupExperimental treatment 1 intervention

Group B: Healthy Control GroupPlacebo comparator 1 intervention

Group C: Type 1 Diabetes Mellitus Control GroupActive comparator 1 intervention

Trial outcomes

Primary outcomes

Liver Fat Quantification

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

Secondary outcomes

Blood biochemistry indicators

1. Liver Function Tests (LFTs) Includes: Alanine aminotransferase (ALT), Aspartate aminotransferase (AST), Albumin (ALB), Total bilirubin (TBIL), etc. 2. Kidney Function Tests Includes: Blood urea nitrogen (BUN), Creatinine (Cr), Estimated glomerular filtration rate (eGFR), etc. 2\. Lipid Panel Includes (TG), High-density lipoprotein cholesterol (HDL-C), Low-density lipoprotein cholesterol (LDL-C), etc. 3\. Glucose Metabolism Markers Includes: Fasting blood glucose (FBG), Oral glucose tolerance test (OGTT), Glycated hemoglobin (HbA1c), etc. 4\. Pancreatic Islet Function Tests Includes: Fasting insulin, C-peptide, Glucose-stimulated insulin secretion test (e.g., after OGTT), etc.

Time frame

From enrollment to the end of treatment at 12 weeks

Other outcomes

Anthropometric Indicators

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

Time frame

From enrollment to the end of treatment at 12 weeks

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

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

Lead sponsor

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: