CoQ10 Effects on MDM Liver Fat Via FibroTouchI. | NCT07748130

NCT07748130

Overview

NCT ID: NCT07748130
Lead Sponsor: The 95th Hospital of Putian，Putian, Fujian, ChinaOTHER
Official Title: The Effect of Coenzyme Q10 on Quantitative Changes in Hepatic Fat in Patients With Mitochondrial Diabetes
Brief 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.
Conditions

Status and Timeline

Status: Not yet recruiting
Last Update Posted: Aug 5, 2026Actual
Start Date: Sep 2026Estimated
Primary Completion Date: Sep 2027Estimated
Completion Date

Participation Criteria

Ages Eligible for Study: Adult (18-64)Older Adult (65+)
Sexes Eligible for Study: All
Accepts Healthy Volunteers?: Yes
Eligibility Criteria: 1. 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.

Study Plan

Study Type: Interventional
Phase: Not Applicable
Enrollment: 30Estimated
Primary Purpose: Treatment
Allocation: Non-Randomized
Interventional Model: Parallel Assignment
Masking

Contacts and Locations

Central Contacts: Jing LinContact
564310896@qq.com

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Participant Group/Arms

Mitochondrial Disease Experimental GroupExperimental

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.

Drug: Coenzyme Q10 (drug)

Healthy Control GroupPlacebo Comparator

Only undergo baseline assessments without intervention. 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.

Other: Only undergo baseline assessments without intervention.

Type 1 Diabetes Mellitus Control GroupActive Comparator

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.

Other: Only undergo baseline assessments without intervention.

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