The Effect of Coenzyme Q10 on Quantitative Changes in Hepatic Fat in Patients With Mitochondrial Diabetes
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Liver Fat Quantification
研究概览
简要总结
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.
详细描述
- 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. 2. 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).
研究设计
- 研究类型
- Interventional
- 分配方式
- Non Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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.
排除标准
- •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.
- •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.
- •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.
研究组 & 干预措施
Mitochondrial Disease Experimental Group
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.
干预措施: Coenzyme Q10 (drug) (Drug)
Healthy Control Group
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.
干预措施: Only undergo baseline assessments without intervention. (Other)
Type 1 Diabetes Mellitus Control Group
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.
干预措施: Only undergo baseline assessments without intervention. (Other)
结局指标
主要结局
Liver Fat Quantification
时间窗: 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.
次要结局
- Blood biochemistry indicators(From enrollment to the end of treatment at 12 weeks)